EMA CHMP Meeting Agenda February 2026
Summary
The European Medicines Agency (EMA) has published the draft agenda for the Committee for Medicinal Products for Human Use (CHMP) meeting scheduled for February 23-26, 2026. The agenda outlines topics for discussion, including pre-authorisation and post-authorisation procedures for various medicinal products.
What changed
The European Medicines Agency (EMA) has released the draft agenda for the CHMP meeting taking place from February 23-26, 2026. The document details the planned discussions, which include oral explanations for pre-authorisation procedures (e.g., Furosemide, Copper (64Cu) oxodotreotide, Leniolisib) and post-authorisation procedures (e.g., Olumiant, Symtuza). Some information is marked as commercially confidential and will not be disclosed.
This agenda serves as a working document for CHMP members and provides insight into the committee's upcoming activities. Regulated entities, particularly drug manufacturers and pharmaceutical companies, can use this to anticipate potential discussions and review timelines for specific products. No immediate compliance actions are required based solely on this agenda, but it indicates areas of focus for the EMA in the near future.
Source document (simplified)
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged. 23 February 2026 Human Medicines Division Draft agenda for the meeting on 23-26 February 2026 Chair: Bruno Sepodes – Vice-Chair: Outi Mäki-Ikola 23 February 2026, 09:00 – 19:30, virtual meeting/room 2E 24 February 2026, 08:30 – 19:30, virtual meeting/room 2E 25 February 2026, 08:30 – 19:30, virtual meeting/room 2E 26 February 2026, 08:30 – 15:00, virtual meeting/room 2E Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006).
Page 2/38 Table of contents 1. Introduction 8 1.1. Welcome and declarations of interest of members, alternates and experts ............ 8 1.2. Adoption of agenda ................................................................................................ 8 1.3. Adoption of the minutes ......................................................................................... 8 2. Oral Explanations 8 2.1. Pre-authorisation procedure oral explanations ....................................................... 8 2.1.1. Furosemide - PUMA - EMEA/H/C/006617 ...................................................................... 8 2.1.2. Copper (64Cu) oxodotreotide - Orphan - EMEA/H/C/006608 ........................................... 8 2.1.3. Leniolisib - Orphan - EMEA/H/C/005927 ....................................................................... 9 2.1.4. Remibrutinib - EMEA/H/C/006313 ................................................................................ 9 2.1.5. Mavorixafor - Orphan - EMEA/H/C/006496 .................................................................... 9 2.2. Re-examination procedure oral explanations ......................................................... 9 2.3. Post-authorisation procedure oral explanations ..................................................... 9 2.3.1. Olumiant – Baricitinib - EMA/X/0000257923 ................................................................. 9 2.3.2. Symtuza – Darunavir / Cobicistat / Emtricitabine / Tenofovir alafenamide - EMA/X/0000248421 ............................................................................................................................. 10 2.4. Referral procedure oral explanations ................................................................... 10 3. Initial applications 10 3.1. Initial applications; Opinions ................................................................................ 10 3.1.1. Acoziborole - Article 58 - EMEA/H/W/006686 .............................................................. 10 3.1.2. Insulin lispro - EMEA/H/C/006158 .............................................................................. 10 3.1.3. Trofinetide - Orphan - EMEA/H/C/006482 ................................................................... 10 3.1.4. Insulin aspart - EMEA/H/C/006187 ............................................................................ 11 3.1.5. Iloperidone - EMEA/H/C/006561 ................................................................................ 11 3.1.6. Etanercept - EMEA/H/C/006738 ................................................................................ 11 3.1.7. Influenza and COVID-19 vaccine - EMEA/H/C/006472 .................................................. 11 3.1.8. Tovorafenib - Orphan - EMEA/H/C/006140 .................................................................. 11 3.1.9. Levodopa / Carbidopa - EMEA/H/C/006429 ................................................................. 12 3.1.10. Paltusotine - Orphan - EMEA/H/C/006636 ................................................................... 12 3.1.11. Pertuzumab - EMEA/H/C/006583 ............................................................................... 12 3.1.12. Tocilizumab - EMEA/H/C/006416 ............................................................................... 12 3.1.13. Teriparatide - EMEA/H/C/006688 ............................................................................... 12 3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable) ...................................................................... 13 3.2.1. Diazoxide choline - Orphan - EMEA/H/C/006576 .......................................................... 13 3.2.2. Tarlatamab - Orphan - EMEA/H/C/006451 .................................................................. 13
Page 3/38 3.2.3. Nerandomilast - EMEA/H/C/006405 ........................................................................... 13 3.2.4. Colchicine - EMEA/H/C/006653 .................................................................................. 13 3.2.5. Lerodalcibep - EMEA/H/C/006694 .............................................................................. 13 3.2.6. Palbociclib - EMEA/H/C/006624 ................................................................................. 14 3.2.7. Plozasiran - Orphan - EMEA/H/C/006579 .................................................................... 14 3.2.8. Ranibizumab - EMEA/H/C/006634 .............................................................................. 14 3.2.9. Alpelisib - Orphan - EMEA/H/C/006539....................................................................... 14 3.2.10. Onasemnogene abeparvovec - Orphan - ATMP - EMEA/H/C/006498 ............................... 14 3.3. Initial applications; List of questions (Day 120; Day 90 for procedures with accelerated assessment timetable) ...................................................................... 15 3.3.1. Denecimig - EMEA/H/C/006344 ................................................................................. 15 3.3.2. Relacorilant - Orphan - EMEA/H/C/006731 .................................................................. 15 3.3.3. Povorcitinib - EMEA/H/C/006727 ............................................................................... 15 3.3.4. Riociguat - EMEA/H/C/006838 ................................................................................... 15 3.3.5. Ruxolitinib - EMEA/H/C/006791 ................................................................................. 15 3.3.6. RABIES VIRUS (INACTIVATED) STRAIN WISTAR (PM/WI 38-1503-3M) - Article 28 – OPEN - EMEA/H/C/006602 ................................................................................................... 16 3.3.7. Navepegritide - Orphan - EMEA/H/C/006627 ............................................................... 16 3.4. Update on on-going initial applications for Centralised procedure ........................ 16 3.4.1. Azacitidine - EMEA/H/C/006695 ................................................................................. 16 3.5. Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004 ............................................................................................................. 16 3.5.1. Blarcamesine Anavex - Blarcamesine - EMEA/H/C/006475 ............................................ 16 3.6. Initial applications in the decision-making phase ................................................. 16 3.6.1. Enflonsia - Clesrovimab - EMEA/H/C/006497 ............................................................... 16 3.7. Withdrawals of initial marketing authorisation application .................................. 17 3.7.1. Sasanlimab - EMEA/H/C/006641 ............................................................................... 17 4. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 17 4.1. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Opinion ................................................................................ 17 4.1.1. Camcevi – Leuprorelin - EMA/X/0000258054 .............................................................. 17 4.1.2. Jorveza – Budesonide - EMA/X/0000257468 ............................................................... 17 4.1.3. Olumiant – Baricitinib - EMA/X/0000257923 ............................................................... 17 4.1.4. OPDIVO – Nivolumab - EMA/X/0000304427 ................................................................ 18 4.1.5. Scemblix – Asciminib - EMA/X/0000256688 ................................................................ 18 4.1.6. Symtuza – Darunavir / Cobicistat / Emtricitabine / Tenofovir alafenamide - EMA/X/0000248421 ............................................................................................................................. 18 4.2. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 180 list of outstanding issues ....................................... 19
Page 4/38 4.2.1. Lojuxta – Lomitapide - EMA/X/0000258068 ................................................................ 19 4.2.2. Orladeyo – Berotralstat - EMA/X/0000268892 ............................................................. 19 4.2.3. REZOLSTA – Darunavir / Cobicistat - EMA/X/0000268372 ............................................ 20 4.3. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 120 List of question ...................................................... 20 4.3.1. Iclusig – Ponatinib - EMA/X/0000296489 .................................................................... 20 4.3.2. RINVOQ – Upadacitinib - EMA/X/0000304823 ............................................................. 20 4.3.3. Wegovy – Semaglutide - EMA/X/0000304416 ............................................................. 21 4.4. Update on on-going extension application according to Annex I of Commission Regulation (EC) No 1234/2008 ............................................................................ 21 4.5. Re-examination procedure of extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 ....................................... 21 5. Type II variations - variation of therapeutic indication procedure according to Annex I of Commission Regulation (EC) No 1234/20085.1. Type II variations - variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008; Opinions or Requests for supplementary information ........................................................................................................... 21 5.1.1. AQUIPTA – Atogepant - EMA/VR/0000310717 ............................................................. 21 5.1.2. Dupixent – Dupilumab - EMA/VR/0000282164 ............................................................ 22 5.1.3. Fasenra – Benralizumab - EMA/VR/0000288520 .......................................................... 22 5.1.4. Feraccru – Ferric maltol - EMA/VR/0000268118 ........................................................... 22 5.1.5. HETRONIFLY – Serplulimab - EMA/VR/0000290021 ...................................................... 23 5.1.6. IMCIVREE – Setmelanotide - EMA/VR/0000288021 ...................................................... 23 5.1.7. Keytruda – Pembrolizumab - EMA/VR/0000293815 ...................................................... 23 5.1.8. Keytruda – Pembrolizumab - EMA/VR/0000312515 ...................................................... 24 5.1.9. Mounjaro – Tirzepatide - EMA/VR/0000310637............................................................ 24 5.1.10. mRESVIA – Respiratory syncytial virus mRNA vaccine (nucleoside modified) - EMA/VR/0000312911 ............................................................................................... 25 5.1.11. Ocrevus – Ocrelizumab - EMA/VR/0000309389 ........................................................... 25 5.1.12. Olumiant – Baricitinib - EMA/VR/0000288098 ............................................................. 25 5.1.13. Padcev – Enfortumab vedotin - EMA/VR/0000312495................................................... 26 5.1.14. RINVOQ – Upadacitinib - EMA/VR/0000312506 ........................................................... 26 5.1.15. Stelara – Ustekinumab - EMA/VR/0000290099 ............................................................ 26 5.1.16. Tepkinly – Epcoritamab - EMA/VR/0000311043 ........................................................... 27 5.1.17. Trodelvy – Sacituzumab govitecan - EMA/VR/0000312649 ............................................ 27 5.2. Update on on-going Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 .................................... 28 5.3. Re-examination of Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 .................................... 28
Page 5/38 6. Medical devices 28 6.1. Ancillary medicinal substances - initial consultation ............................................ 28 6.2. Ancillary medicinal substances – post-consultation update .................................. 28 6.3. Companion diagnostics - initial consultation ........................................................ 28 6.3.1. In vitro diagnostic medical device - EMEA/H/D/006931 ................................................ 28 6.3.2. In vitro diagnostic medical device - EMEA/H/D/006913 ................................................ 28 6.3.3. In vitro diagnostic medical device - EMEA/H/D/006887 ................................................ 28 6.3.4. In vitro diagnostic medical device - EMEA/H/D/006914 ................................................ 29 6.4. Companion diagnostics – follow-up consultation .................................................. 29 7. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use) 29 7.1. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use)29 8. Pre-submission issues 29 8.1. Pre-submission issue ............................................................................................ 29 8.1.1. Rebisufligene etisparvovec – H0005536 ...................................................................... 29 8.2. Priority Medicines (PRIME) ................................................................................... 29 9. Post-authorisation issues 30 9.1. Post-authorisation issues ..................................................................................... 30 9.1.1. Fluad Tetra – Influenza vaccine (surface antigen, inactivated, adjuvanted) – EMEA/H/C/004993 ............................................................................................................................. 30 9.1.2. Flucelvax Tetra – influenza vaccine (surface antigen, inactivated, prepared in cell cultures) – EMEA/H/C/004814 ................................................................................................... 30 9.1.3. Xevudy – Sotrovimab – EMEA/H/C/005676 ................................................................. 30 10. Referral procedures 30 10.1. Procedure for Centrally Authorised products under Article 20 of Regulation (EC) No 726/2004 ............................................................................................................. 30 10.1.1. Tecovirimat SIGA - Tecovirimat - EMA/REF/0000287477 .............................................. 30 10.2. Requests for CHMP Opinion under Article 5(3) of Regulation (EC) No 726/2004 . 31 10.3. Procedure under Articles 5(2) and 10 of Regulation (EC) No 726/2004 ............... 31 10.4. Disagreement between Member States on application for medicinal product (potential serious risk to public health) –under Article 29(4) of Directive 2001/83/EC ......................................................................................................... 31 10.5. Harmonisation - Referral procedure under Article 30 of Directive 2001/83/EC .... 31 10.6. Community Interests - Referral under Article 31 of Directive 2001/83/EC .......... 31 10.6.1. Sodium oxybate syrup and oral solution for alcohol dependence - EMA/REF/0000278933 . 31 10.7. Re-examination Procedure under Article 32(4) of Directive 2001/83/EC ............. 32 10.8. Procedure under Article 107(2) of Directive 2001/83/EC .................................... 32
Page 6/38 10.9. Disagreement between Member States on Type II variation– Arbitration procedure initiated by MAH under Article 6(13) of Commission Regulation (EC) No 1084/2003 ............................................................................................................................. 32 10.10. Procedure under Article 29 of Regulation (EC) 1901/2006................................... 32 10.11. Referral under Article 13 Disagreement between Member States on Type II variation– Arbitration procedure initiated by Member State under Article 13 (EC) of Commission Regulation No 1234/2008 ................................................................ 32 11. Pharmacovigilance issue 32 11.1. Early Notification System ..................................................................................... 32 12. Inspections 32 12.1. GMP inspections ................................................................................................... 32 12.2. GCP inspections .................................................................................................... 32 12.3. Pharmacovigilance inspections ............................................................................. 33 12.4. GLP inspections .................................................................................................... 33 13. Innovation Task Force 33 13.1. Minutes of Innovation Task Force ......................................................................... 33 13.2. Innovation Task Force briefing meetings .............................................................. 33 13.3. Requests for CHMP Opinion under Article 57(1)J and (1)P of Regulation (EC) No 726/2004 ............................................................................................................. 33 13.3.1. EC Request for EMA scientific opinion ......................................................................... 33 13.4. Nanomedicines activities ...................................................................................... 33 14. Organisational, regulatory and methodological matters 33 14.1. Mandate and organisation of the CHMP ................................................................ 33 14.1.1. Vote by Proxy ......................................................................................................... 33 14.1.2. CHMP membership ................................................................................................... 34 14.2. Coordination with EMA Scientific Committees....................................................... 34 14.2.1. Pharmacovigilance Risk Assessment Committee (PRAC) ............................................... 34 14.2.2. Paediatric Committee (PDCO) .................................................................................... 34 14.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups ......... 34 14.3.1. Biologics Working Party (BWP) .................................................................................. 34 14.3.2. Name Review Group (NRG) ....................................................................................... 34 14.3.3. Scientific Advice Working Party (SAWP) ...................................................................... 34 14.3.4. SAWP composition ................................................................................................... 35 14.4. Cooperation within the EU regulatory network ..................................................... 35 14.5. Cooperation with International Regulators........................................................... 35 14.6. Contacts of the CHMP with external parties and interaction with the Interested Parties to the Committee ...................................................................................... 35 14.7. CHMP work plan ................................................................................................... 35
Page 7/38 14.8. Planning and reporting ......................................................................................... 35 14.9. Others .................................................................................................................. 35 15. Any other business 35 15.1. AOB topic .............................................................................................................. 35 15.1.1. GIREX rules ............................................................................................................ 35 Explanatory notes 36
Page 8/38 1. Introduction 1.1. Welcome and declarations of interest of members, alternates and experts Pre-meeting list of participants and restrictions in relation to declarations of interests applicable to the items of the agenda for the CHMP plenary session to be held 23-26 February 2026. See February 2026 CHMP minutes (to be published post March 2026 CHMP meeting). 1.2. Adoption of agenda CHMP agenda for 23-26 February 2026 1.3. Adoption of the minutes CHMP minutes for 10-13 November 2025 meeting Minutes from PReparatory and Organisational Matters (PROM) meeting held on 16 February 2026. 2. Oral Explanations 2.1. Pre-authorisation procedure oral explanations 2.1.1. Furosemide - PUMA - EMEA/H/C/006617 treatment of all conditions requiring diuresis due to mechanical obstruction or venous insufficiency. Action: Oral explanation to be held on 25 February 2026 at 09:00 2.1.2. Copper (64Cu) oxodotreotide - Orphan - EMEA/H/C/006608 Cis Bio International; positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine neoplasms (NENs). Action: Oral explanation to be held on 24 February 2026 at 09:00
Page 9/38 2.1.3. Leniolisib - Orphan - EMEA/H/C/005927 Pharming Technologies B.V.; Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) Action: Oral explanation to be held on 25 February 2026 at 16:00 List of Outstanding Issues adopted on 30.05.2024, 25.01.2024, 09.11.2023, 20.07.2023. List of Questions adopted on 24.01.2023. 2.1.4. Remibrutinib - EMEA/H/C/006313 treatment of chronic spontaneous urticaria in patients with inadequate response to H1 antihistamine Action: Oral explanation to be held on 25 February 2026 at 14:00 2.1.5. Mavorixafor - Orphan - EMEA/H/C/006496 X4 Pharmaceuticals (Austria) GmbH; Treatment of WHIM syndrome Action: Oral explanation to be held on 24 February 2026 at 16:00 22.05.2025. 2.2. Re-examination procedure oral explanations No items 2.3. Post-authorisation procedure oral explanations 2.3.1. Olumiant – Baricitinib - EMA/X/0000257923 Action: Oral explanation to be held on 25 February 2026 at 11:00 See 4.1
Page 10/38 2.3.2. Symtuza – Darunavir / Cobicistat / Emtricitabine / Tenofovir alafenamide - EMA/X/0000248421 Rapporteur: Patrick Vrijlandt, PRAC Rapporteur: Ana Sofia Diniz Martins Action: Oral explanation to be held on 24 February 2026 at 14:00 See 4.1 2.4. Referral procedure oral explanations No items 3. Initial applications 3.1. Initial applications; Opinions 3.1.1. Acoziborole - Article 58 - EMEA/H/W/006686 Accelerated assessment treatment of first and second-stage human African Trypanosomiases due to Trypanosoma brucei gambiense List of Questions adopted on 09.12.2025. 3.1.2. Insulin lispro - EMEA/H/C/006158 treatment of diabetes mellitus 25.01.2024. 3.1.3. Trofinetide - Orphan - EMEA/H/C/006482 Acadia Pharmaceuticals (Netherlands) B.V.; treatment of Rett syndrome in adults and paediatric patients 2 years of age and older
Page 11/38 List of Outstanding Issues adopted on 16.10.2025. List of Questions adopted on 22.05.2025. 3.1.4. Insulin aspart - EMEA/H/C/006187 treatment of diabetes mellitus from 1 year of age 25.01.2024. 3.1.5. Iloperidone - EMEA/H/C/006561 treatment of schizophrenia, acute treatment of manic or mixed episodes associated with bipolar I disorder List of Outstanding Issues adopted on 13.11.2025, 18.09.2025. List of Questions adopted on 25.04.2025. 3.1.6. Etanercept - EMEA/H/C/006738 Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, paediatric plaque psoriasis List of Questions adopted on 16.10.2025. 3.1.7. Influenza and COVID-19 vaccine - EMEA/H/C/006472 immunisation for the prevention of diseases associated with seasonal influenza viruses and SARS-CoV-2 22.05.2025. 3.1.8. Tovorafenib - Orphan - EMEA/H/C/006140 Ipsen Pharma; treatment of paediatric low-grade glioma (LGG)
Page 12/38 3.1.9. Levodopa / Carbidopa - EMEA/H/C/006429 treatment of motor fluctuations in patients with Parkinson’s disease 19.06.2025. 3.1.10. Paltusotine - Orphan - EMEA/H/C/006636 Crinetics Pharmaceuticals Europe GmbH; Maintenance treatment in adult patients with acromegaly 3.1.11. Pertuzumab - EMEA/H/C/006583 treatment of breast cancer in adults 3.1.12. Tocilizumab - EMEA/H/C/006416 treatment of rheumatoid arthritis and other immunological conditions 3.1.13. Teriparatide - EMEA/H/C/006688 treatment of osteoporosis
Page 13/38 List of Outstanding Issues adopted on 13.11.2025. List of Questions adopted on 19.06.2025. 3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable) 3.2.1. Diazoxide choline - Orphan - EMEA/H/C/006576 Soleno Therapeutics Europe Limited; treatment of adult and paediatric patients with Prader- Willi syndrome (PWS) 3.2.2. Tarlatamab - Orphan - EMEA/H/C/006451 Amgen Europe B.V.; treatment of extensive-stage small cell lung cancer List of Questions adopted on 13.11.2025. 3.2.3. Nerandomilast - EMEA/H/C/006405 treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF) and adult patients with Progressive Pulmonary Fibrosis (PPF). 3.2.4. Colchicine - EMEA/H/C/006653 indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in patients with atherosclerotic disease or with multiple risk factors for cardiovascular disease. 3.2.5. Lerodalcibep - EMEA/H/C/006694 is indicated in adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and
Page 14/38 non-familial) or mixed dyslipidaemia as an adjunct to diet. 3.2.6. Palbociclib - EMEA/H/C/006624 treatment of breast cancer factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy 3.2.7. Plozasiran - Orphan - EMEA/H/C/006579 Arrowhead Pharmaceuticals Ireland Limited; treatment of familial chylomicronaemia syndrome (FCS). List of Questions adopted on 17.06.2025. 3.2.8. Ranibizumab - EMEA/H/C/006634 treatment of adults with neovascular (wet) age-related macular degeneration (AMD), visual impairment and other retinopathies List of Questions adopted on 16.10.2025. 3.2.9. Alpelisib - Orphan - EMEA/H/C/006539 Novartis Europharm Limited; treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS) 3.2.10. Onasemnogene abeparvovec - Orphan - ATMP - EMEA/H/C/006498 Novartis Europharm Limited; treatment of 5q spinal muscular atrophy (SMA)
Page 15/38 List of Questions adopted on 12.09.2025. 3.3. Initial applications; List of questions (Day 120; Day 90 for procedures with accelerated assessment timetable) 3.3.1. Denecimig - EMEA/H/C/006344 prophylaxis of bleeding episodes in patients with haemophilia A Scope: List of questions 3.3.2. Relacorilant - Orphan - EMEA/H/C/006731 Corcept Therapeutics Netherlands B.V.; treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer Scope: List of questions 3.3.3. Povorcitinib - EMEA/H/C/006727 treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults Scope: List of questions 3.3.4. Riociguat - EMEA/H/C/006838 treatment of Chronic thromboembolic pulmonary hypertension (CTEPH) in adults and treatment of Pulmonary arterial hypertension (PAH) in adults and children from 6 years of age Scope: List of questions 3.3.5. Ruxolitinib - EMEA/H/C/006791 treatment of myelofibrosis (MF) in adults, treatment of polycythaemia vera (PV) in adults and treatment of Graft versus host disease (GvHD) in adults and children Scope: List of questions
Page 16/38 3.3.6. RABIES VIRUS (INACTIVATED) STRAIN WISTAR (PM/WI 38-1503-3M) - Article 28 – OPEN - EMEA/H/C/006602 pre-exposure and post-exposure prophylaxis against rabies in all age groups Scope: List of questions 3.3.7. Navepegritide - Orphan - EMEA/H/C/006627 Ascendis Pharma Growth Disorders A/S; treatment of achondroplasia in children Scope: List of questions 3.4. Update on on-going initial applications for Centralised procedure 3.4.1. Azacitidine - EMEA/H/C/006695 Treatment of myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML) Scope: Request by the applicant for an extension to the clock stop to respond to the list of questions adopted in December 2025. List of questions adopted on 11.12.2025. 3.5. Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004 3.5.1. Blarcamesine Anavex - Blarcamesine - EMEA/H/C/006475 Anavex Germany GmbH; treatment of Alzheimer’s disease and dementia Scope: Adoption of timetable; questions to the SAG-N Opinion adopted on 11.12.2025. List of Outstanding Issues adopted on 18.09.2025. List of Questions adopted on 25.04.2025. 3.6. Initial applications in the decision-making phase 3.6.1. Enflonsia - Clesrovimab - EMEA/H/C/006497 Merck Sharp & Dohme B.V.; prevention of infections with respiratory syncytial virus (RSV) and lower respiratory tract disease (LRTD) Scope: Revised opinion. Revised dataset submitted by the applicant
Page 17/38 Opinion adopted on 18.09.2025. List of Outstanding Issues adopted on 24.07.2025. List of Questions adopted on 27.03.2025. 3.7. Withdrawals of initial marketing authorisation application 3.7.1. Sasanlimab - EMEA/H/C/006641 treatment of bladder cancer Scope: Withdrawal of marketing authorisation application 4. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 4.1. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Opinion 4.1.1. Camcevi – Leuprorelin - EMA/X/0000258054 Accord Healthcare S.L.U. Rapporteur: Johanna Lähteenvuo, PRAC Rapporteur: Amelia Cupelli Scope: Extension application to add a new strength of 21 mg for Leuprorelin prolonged- release suspension for injection pre-filled syringe, for subcutaneous (SC) administration. 4.1.2. Jorveza – Budesonide - EMA/X/0000257468 Dr. Falk Pharma GmbH Rapporteur: Janet Koenig, PRAC Rapporteur: Zane Neikena strength (0.2 mg/ml oral suspension). The new presentation is indicated for paediatric patients 2 to 17 years of age. 4.1.3. Olumiant – Baricitinib - EMA/X/0000257923
Page 18/38 Scope: Extension application to introduce a new pharmaceutical form (oral suspension) associated with a new strength (2 mg/ml). See 2.3 4.1.4. OPDIVO – Nivolumab - EMA/X/0000304427 Bristol-Myers Squibb Pharma EEIG Rapporteur: Carolina Prieto Fernandez, PRAC Rapporteur: Dirk Mentzer Scope: Extension application to add a new strength of 300 mg solution for injection. 4.1.5. Scemblix – Asciminib - EMA/X/0000256688 Novartis Europharm Limited Rapporteur: Martin Mengel, Co-Rapporteur: Peter Mol, PRAC Rapporteur: Eva Jirsová Scope: Extension application to introduce a new strength (100 mg film-coated tablets) grouped with a type II variation (C.I.6.a) to add a new indication (treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) harbouring the T315I mutation), based on final results from study CABL001X2101 and study CABL001A2004. Study CABL001X2101 is a Phase I, multicentre, open-label, dose escalation FIH study to define the MTD/RDEs, to characterize safety and tolerability, and to assess the PK profile and preliminary evidence of efficacy of asciminib given as single agent or in combination with either nilotinib or imatinib or dasatinib in patients with Ph+ CML or Ph+ ALL. Study CABL001A2004 assessed the real-world effectiveness of asciminib and treatment patterns in patients with Chronic Myeloid Leukaemia with T315I mutation. As a consequence, sections 1, 2, 3, 4, 5, 6 and 8 of the SmPC are updated. The Package Leaflet and Labelling are updated in accordance. Version 3.0 of the RMP has also been submitted. As part of the application the MAH is requesting a 1-year extension of the market protection. 4.1.6. Symtuza – Darunavir / Cobicistat / Emtricitabine / Tenofovir alafenamide - EMA/X/0000248421 Rapporteur: Patrick Vrijlandt, PRAC Rapporteur: Ana Sofia Diniz Martins Scope: Extension application to add a new strength of 675 mg/150 mg/ 20mg/ 10 mg film- coated tablets grouped with an Extension of indication (C.I.6) to include treatment of human immunodeficiency virus type 1 (HIV 1) infection in paediatric patients (aged 6 years and older with body weight at least 25 kg) for SYMTUZA, based on the 24-week interim results from study GS-US-216-0128 (Cohort 2); this is a Phase II/III, multicentre, open- label, multicohort interventional study evaluating efficacy, safety, and pharmacokinetics of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and
Page 19/38 Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 infected children. As a consequence, sections 1, 2, 3, 4.1, 4.2, 4.8, 5.1, 5.2, 6.1, 6.3, 6.4, 6.5 and 8 of the SmPC are updated. The Annex II, Labelling and Package Leaflet are updated accordingly. Version 9.1 of the RMP has also been submitted. Furthermore, the MAH took the opportunity to bring the PI in line with the latest QRD template version 10.4 and to update the list of local representatives in the Package Leaflet. See 2.3 4.2. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 180 list of outstanding issues 4.2.1. Lojuxta – Lomitapide - EMA/X/0000258068 Chiesi Farmaceutici S.p.A. Rapporteur: Patrick Vrijlandt, PRAC Rapporteur: Bianca Mulder Scope: Extension application to add a new strength of 2 mg hard capsules. This application is grouped with - type II variation (C.I.6.a): an Extension of Indication to include treatment of paediatric patients aged 5 years and older with homozygous familial hypercholesterolaemia (HoFH) for LOJUXTA, based on final results from the pivotal paediatric study APH-19; this is a phase 3, single-arm, open-label, international, multi-centre study to evaluate the efficacy and safety of lomitapide in paediatric patients with homozygous familial hypercholesterolaemia (HOFH) on stable lipid-lowering therapy. As a consequence, sections 4.1, 4.2, 4.4, 4.6, 4.8, 5.1, 5.2 and 5.3 of the SmPC are updated. The Annex II and Package Leaflet are updated accordingly. The RMP version 7.1 has also been submitted. In addition, the MAH took the opportunity to bring the PI in line with the latest QRD template version 10.4. - 3 x type IB variations (C.I.7.b): to delete the 30 mg, 40 mg and 60 mg strengths from the Lojuxta marketing authorisation (EU/1/13/851/004 - 006). 4.2.2. Orladeyo – Berotralstat - EMA/X/0000268892 Biocryst Ireland Limited Rapporteur: Finbarr Leacy, Co-Rapporteur: Margareta Bego, PRAC Rapporteur: Julia Pallos strengths (78 mg, 96 mg,108 and 132 film - coated granules). The new presentations are indicated to include treatment for paediatric patients aged 2 to less than 12 years. The extension application is grouped with a type II clinical variation (C.I.4). As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet and Labelling are updated in accordance. Version 2.1 of the RMP has also been submitted.
Page 20/38 4.2.3. REZOLSTA – Darunavir / Cobicistat - EMA/X/0000268372 Rapporteur: Patrick Vrijlandt, PRAC Rapporteur: Amelia Cupelli strength (600 mg darunavir/90 mg cobicistat dispersible tablet). The new presentation is indicated to include treatment for paediatric patients aged ≥ 3 years and older weighing at least 15 kg and less than 25 kg. The extension application is grouped with a type II clinical variation (C.I.4) to update sections 4.2, 4.4, 4.8, 5.1 and 5.2 in order to add efficacy and PK data in children based on final results from study GS-US-215-0128; this is a Phase 2/3, Multicentre, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Paediatric Participants. The Package Leaflet and Labelling are updated in accordance. Version 7.2 of the RMP has also been submitted. 4.3. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 120 List of question 4.3.1. Iclusig – Ponatinib - EMA/X/0000296489 Incyte Biosciences Distribution B.V. Rapporteur: Filip Josephson, Co-Rapporteur: Ewa Balkowiec Iskra, PRAC Rapporteur: Mari Thorn Scope: Extension application to introduce a new pharmaceutical form associated with a new strength (5 mg hard capsule) grouped with an Extension of Indication to include treatment of paediatric patients aged 6 years and older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant or intolerant to at least one tyrosine kinase inhibitor for ICLUSIG, based on interim results from study INCB 84344-102 and a final results from early-terminated study Ponatinib-1501; the first is an ongoing open-label, single-arm, Phase 1/2 study evaluating the safety and efficacy of ponatinib MONOTHERAPY for the treatment of R/R leukaemia, lymphomas, or solid tumours in paediatric participants. The second is a Phase 1/2, single-arm, open-label, multicentre study designed to evaluate the safety, tolerability, PK, and efficacy of ponatinib when administered IN COMBINATION WITH multiagent CHEMOTHERAPY in paediatric patients with Ph+ ALL, Ph+ MPAL, or Ph-like ALL who had a relapse, were resistant or intolerant to at least 1 prior BCR-ABL1 TKI therapy, or had the T315I mutation. As a consequence, sections 1, 2, 3, 4.1, 4.2, 4.8, 5.1, 5.2, 6.1 and 6.5 of the SmPC are updated. Package Leaflet is updated accordingly. The RMP version 23.4 has also been submitted. 4.3.2. RINVOQ – Upadacitinib - EMA/X/0000304823
Page 21/38 Rapporteur: Kristina Dunder, PRAC Rapporteur: Petar Mas Scope: Extension application to introduce a new pharmaceutical form associated with a new strength and change of pharmacokinetics (1 mg/ml oral solution) grouped with an extension of indication (C.I.6.a) to include the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older based on clinical data and results from clinical phase 1 study (study M15-340). As a consequence, sections 4.1, 4.2, 4.5, 4.8, 5.1, 5.2 and 5.3 of the SmPC have been updated. The Package Leaflet has been updated accordingly. Version 17 of the RMP has also been submitted. In addition, the MAH took the opportunity to update Annex II. 4.3.3. Wegovy – Semaglutide - EMA/X/0000304416 Novo Nordisk A/S Rapporteur: Patrick Vrijlandt Scope: Extension application to add a new strength of 7.2 mg in a single dose pen-injector. 4.4. Update on on-going extension application according to Annex I of Commission Regulation (EC) No 1234/2008 No items. 4.5. Re-examination procedure of extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 No items. 5. Type II variations - variation of therapeutic indication procedure according to Annex I of Commission Regulation (EC) No 1234/2008 5.1. Type II variations - variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008; Opinions or Requests for supplementary information 5.1.1. AQUIPTA – Atogepant - EMA/VR/0000310717 Rapporteur: Janet Koenig, Co-Rapporteur: Ewa Balkowiec Iskra, PRAC Rapporteur: Rugile Pilviniene Scope: A grouped application comprised of 1 Type II Variation and 3 Quality Type I Variations, as follows:
Page 22/38 Type II (C.I.6): Extension of indication to include acute treatment of migraine with or without aura in adults, based on interim results from study M24-305; this is a 24-week, global, Phase 3, multicentre, randomized, double blind, placebo-controlled, multiple- migraine attack study with an open label period to evaluate the safety and efficacy of atogepant in adult participants for the acute treatment of migraine (ECLIPSE). As a consequence, sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 2.2 of the RMP has also been submitted. 5.1.2. Dupixent – Dupilumab - EMA/VR/0000282164 Sanofi Winthrop Industrie Rapporteur: Jan Mueller-Berghaus, PRAC Rapporteur: Kimmo Jaakkola Scope: Extension of indication to include treatment of moderate to severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years whose disease is inadequately controlled by H1 antihistamines and who are naive to anti-IgE therapy for CSU for DUPIXENT, based on the results from study PKM16982; this is a multi-centre, single-arm study to investigate the pharmacokinetics and safety of dupilumab in male and female participants ≥2 years to <12 years of age with uncontrolled chronic spontaneous urticaria (CSU). Consequently, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 14.0 of the RMP has also been submitted. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet. Furthermore, the PI is brought in line with the latest QRD template. 5.1.3. Fasenra – Benralizumab - EMA/VR/0000288520 AstraZeneca AB Rapporteur: Paulo Paixão, PRAC Rapporteur: David Olsen Scope: Extension of indication to include treatment of adults and adolescents with hypereosinophilic syndrome (HES) for FASENRA, based on interim results from study D3254C00001 (NATRON); this is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, 24-week phase III study with an open-label extension to evaluate the efficacy and safety of benralizumab in patients with HES; As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 8 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to introduce editorial and administrative updates to the PI and to update the list of local representatives in the Package Leaflet. Furthermore, section 6.5 of the SmPC was updated. 5.1.4. Feraccru – Ferric maltol - EMA/VR/0000268118 Norgine B.V. Rapporteur: Antonio Gomez-Outes, PRAC Rapporteur: Adam Przybylkowski
Page 23/38 Scope: Extension of indication to include treatment of paediatric population (adolescents aged 12 years and above) for FERACCRU, based on results from phase 1 study ST10-01- 103, phase 3 study ST10-01-305 and a supportive phase 1 study ST10-01-104. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 9.1 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to update the list of local representatives in the Package Leaflet and to implement editorial changes to the PI. Furthermore, the PI is brought in line with the latest QRD template version 10.4 5.1.5. HETRONIFLY – Serplulimab - EMA/VR/0000290021 Accord Healthcare S.L.U. Rapporteur: Eva Skovlund, PRAC Rapporteur: Jan Neuhauser Scope: Extension of indication to include HETRONIFLY in combination with carboplatin and nab-paclitaxel is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma based on final results from study HLX10-004-NSCLC303; this is a randomized, double-blind, multi-centre, phase III pivotal study, was conducted to compare the clinical efficacy and safety of serplulimab combined with chemotherapy (carboplatin and nab-paclitaxel) versus placebo combined with chemotherapy (carboplatin and nab-paclitaxel). As a consequence, sections 4.1, 4.2, 4.8, 5.1, 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. The RMP Version 1.3 has been submitted. 5.1.6. IMCIVREE – Setmelanotide - EMA/VR/0000288021 Rhythm Pharmaceuticals Netherlands B.V. Rapporteur: Karin Janssen van Doorn, PRAC Rapporteur: Miroslava Gocova Scope: Extension of indication to include reduction in hunger (or hyperphagia) and BMI (Body Mass Index)/BMI z-score, improvement of metabolic parameters, and increase in energy expenditure in adults and children 4 years of age and above, following rapid and severe weight gain associated with hypothalamic injury and/or impairment for IMCIVREE, based on results from study RM-493-040 as well as supportive study RM-493-030. RM-493- 040 is a phase 3, double blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of setmelanotide in patients with acquired hypothalamic obesity, while RM-493- 030 is a phase 2, open-label 20-week study to evaluate the safety and efficacy of setmelanotide in subjects with hypothalamic obesity. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are being updated. The Package Leaflet is updated accordingly. The RMP version 3.0 has also been submitted. In addition, the MAH took the opportunity to introduce editorial and administrative changes to the PI. 5.1.7. Keytruda – Pembrolizumab - EMA/VR/0000293815 Merck Sharp & Dohme B.V.
Page 24/38 Rapporteur: Paolo Gasparini, PRAC Rapporteur: Bianca Mulder Scope: Extension of indication to include in combination with paclitaxel, with or without bevacizumab, the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens for KEYTRUDA, based on interim results from study PB96V01MK3475 (KEYNOTE-B96); this is a Phase 3, randomized, double-blind study of pembrolizumab in combination with paclitaxel with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. As a consequence, sections 4.1 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 50.1 of the RMP has also been submitted. In addition, the MAH took the opportunity to introduce minor editorial changes to the PI. 5.1.8. Keytruda – Pembrolizumab - EMA/VR/0000312515 Merck Sharp & Dohme B.V. Rapporteur: Paolo Gasparini, PRAC Rapporteur: Bianca Mulder Scope: Extension of indication to include in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment of adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin containing chemotherapy for KEYTRUDA, based on interim results from study KEYNOTE- 905, an open label, randomised, interventional phase 3 study. As consequence, sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 51.1 of the RMP has also been submitted. 5.1.9. Mounjaro – Tirzepatide - EMA/VR/0000310637 Rapporteur: Janet Koenig, PRAC Rapporteur: Bianca Mulder Scope: Extension of indication to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, or stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease for MOUNJARO, based on final results from study I8F-MC-GPGN (SURPASS-CVOT). SURPASS-CVOT was a Phase 3, event-driven, multicentre, international, randomized, double-blind, active-comparator, parallel-group study to assess the effect of tirzepatide versus dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes. As a consequence, sections 4.1, 4.4, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 8.1 of the RMP has also been submitted. In addition, the MAH took the opportunity to introduce minor editorial and formatting changes to the PI.
Page 25/38 5.1.10. mRESVIA – Respiratory syncytial virus mRNA vaccine (nucleoside modified) - EMA/VR/0000312911 Moderna Biotech Spain S.L. Rapporteur: Jan Mueller-Berghaus, PRAC Rapporteur: Jean-Michel Dogné Scope: Extension of indication to include active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in all adults 18 years of age and older for mRESVIA, based on results from Study mRNA-1345-P101, Study mRNA-1345-P301, Study mRNA-1345-P303 Part A, and Study mRNA-1345-P302 Part A and Part B. As a consequence, sections 4.1, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 5.0 of the RMP has also been submitted. 5.1.11. Ocrevus – Ocrelizumab - EMA/VR/0000309389 Roche Registration GmbH Rapporteur: Thalia Marie Estrup Blicher, PRAC Rapporteur: Dirk Mentzer Scope: Extension of indication to include treatment of paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (RRMS) for OCREVUS, based on primary analysis results from the pivotal phase III study (WN42086/Operetta 2) and primary and updated results from a supportive phase II study (WA39085/Operetta 1). Operetta 1 is an open-label, parallel-group, dose-finding Phase II study to determine the dosing regimen of ocrelizumab to be further investigated in Operetta 2, and Operetta 2 is a Phase III, randomized, double-blind, double-dummy, parallel-group, multicentre, non-inferiority study to evaluate the efficacy and safety of intravenous ocrelizumab in comparison with fingolimod. As a consequence, sections 2, 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 6.6 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 15.0 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to introduce updates to other sections of the SmPC and PL as per previous procedures linguistic review comments (sodium, pH and osmolality), updates to comply with the Excipient Guideline (polysorbates), changes to the list of local representatives in the Package Leaflet, as well as editorial and clarification changes to the PI. 5.1.12. Olumiant – Baricitinib - EMA/VR/0000288098 Scope: Extension of indication to include treatment of adolescent patients (12 to less than 18 years) with severe alopecia areata for OLUMIANT, based on results from study I4V-MC- JAIO; this is a Phase 3, double-blind, randomised, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of baricitinib in children from 6 years to less than 18 years of age with alopecia areata. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 26.1 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to introduce minor editorial changes to the PI and to update the list of local
Page 26/38 representatives in the Package Leaflet. 5.1.13. Padcev – Enfortumab vedotin - EMA/VR/0000312495 Astellas Pharma Europe B.V. Rapporteur: Thalia Marie Estrup Blicher, PRAC Rapporteur: Eva Jirsová Scope: Extension of indication to include PADCEV, in combination with pembrolizumab, for use as neoadjuvant treatment and continued as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy, based on interim results from study EV-303/KN-905; this is a randomized phase 3 study evaluating cystectomy with perioperative pembrolizumab and cystectomy with perioperative enfortumab, vedotin and pembrolizumab versus cystectomy alone in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer. As a consequence, sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 5.0 of the RMP has also been submitted. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet, and to bring the PI in line with the latest QRD template version 10.4. 5.1.14. RINVOQ – Upadacitinib - EMA/VR/0000312506 Rapporteur: Kristina Dunder, PRAC Rapporteur: Petar Mas Scope: Extension of indication to include the treatment of severe alopecia areata (AA) in adult and adolescents 12 years and older for RINVOQ, based on interim results from 2 pivotal, Phase 3 studies (M23-716 Study 1 and Study 2); those are randomized, double blind, placebo-controlled, multi-centre studies of Upadacitinib evaluating the efficacy and safety of Upadacitinib 15 mg QD and 30 mg QD versus placebo for the treatment of severe AA in subjects who are at least 12 years of age. As a consequence, sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet and Annex II are updated in accordance. Version 18.0 of the RMP has also been submitted. As part of the application, the MAH is requesting a 1-year extension of the market protection. 5.1.15. Stelara – Ustekinumab - EMA/VR/0000290099 Rapporteur: Ruth Kieran, Co-Rapporteur: Thalia Marie Estrup Blicher, PRAC Rapporteur: Rhea Fitzgerald Scope: Extension of indication to include treatment of moderately to severely active Crohn's disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy, for STELARA, based on final results from the Phase 3 open-label CNTO1275CRD3004 study and
Page 27/38 the supportive results from the Phase 1 PK CNTO1275CRD1001 study. Study CNTO1275CRD3004 is a Phase 3 study of the efficacy, safety, and pharmacokinetics of ustekinumab as open-label intravenous induction treatment followed by randomized double- blind subcutaneous ustekinumab maintenance in paediatric participants 2 to <18 years of age with moderately to severely active Crohn’s disease. As a consequence, sections 4.1, 4.2, 4.8, 5.1, 5.2 and 6.6 of the SmPC are being updated. The Package Leaflet is updated accordingly. The RMP version 32.1 has also been submitted. In addition, the MAH took the opportunity to introduce editorial, formatting and administrative changes to the PI, bringing it in line with the latest QRD template. In addition, the MAH updated the list of local representatives in the Package Leaflet. 5.1.16. Tepkinly – Epcoritamab - EMA/VR/0000311043 Rapporteur: Peter Mol, PRAC Rapporteur: Maria Martinez Gonzalez Scope: Extension of indication to include in combination with rituximab and lenalidomide treatment of patients with relapsed/refractory follicular lymphoma (FL) for Tepkinly, based on interim results from study M20-638; this is a Phase 3, open-label study to evaluate safety and efficacy of epcoritamab in combination with rituximab and lenalidomide (R2) compared to R2 in subjects with relapsed or refractory follicular lymphoma (EPCORE FL-1). As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 3.2.0 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to introduce minor changes to the PI. As part of the application, the MAH is requesting a 1- year extension of the market protection. 5.1.17. Trodelvy – Sacituzumab govitecan - EMA/VR/0000312649 Gilead Sciences Ireland Unlimited Company Rapporteur: Jan Mueller-Berghaus, PRAC Rapporteur: Bianca Mulder Scope: Extension of indication for treatment of adult patients with PD-L1-negative metastatic triple- negative breast cancer or PD-L1-positive metastatic triple-negative breast cancer previously treated with an anti-PD-(L)1 agent in the curative setting for Trodelvy, based on results from study GS-US-592-6238 (ASCENT-03), which is a phase 3 study of sacituzumab govitecan (IMMU-132) versus treatment of physician's choice (TPC) in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumours Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumours Do Express PD-L1. As a consequence, sections 4.1, 4.4, 4.5, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 4.1 of the RMP has also been submitted.
Page 28/38 5.2. Update on on-going Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 No items 5.3. Re-examination of Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 No items 6. Medical devices 6.1. Ancillary medicinal substances - initial consultation No items 6.2. Ancillary medicinal substances – post-consultation update No items 6.3. Companion diagnostics - initial consultation 6.3.1. In vitro diagnostic medical device - EMEA/H/D/006931 qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients; defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumour tissue (FFPET) or circulating cell-free tumour DNA (cfDNA) 6.3.2. In vitro diagnostic medical device - EMEA/H/D/006913 to detect genomic alterations including short variants, rearrangements, and select copy number alterations in 324 genes across 16 cellular pathways and genomic signatures associated with cancer 6.3.3. In vitro diagnostic medical device - EMEA/H/D/006887 assay for the detection of single nucleotide variants coding five IDH1 mutations (R132C, R132H, R132G, R132S, and R132L) in DNA
Page 29/38 6.3.4. In vitro diagnostic medical device - EMEA/H/D/006914 in vitro diagnostic test that uses targeted next-generation sequencing to enable assessment of Homologous Recombination Deficiency (HRD) 6.4. Companion diagnostics – follow-up consultation No items 7. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use) 7.1. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use) No items 8. Pre-submission issues 8.1. Pre-submission issue 8.1.1. Rebisufligene etisparvovec – H0005536 for the treatment of children from birth to less than 18 years of age with mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A) Scope: Briefing note and the Rapporteurs’ recommendation on the request for accelerated assessment. 8.2. Priority Medicines (PRIME) Information related to priority medicines cannot be released at present time as these contain commercially confidential information
Page 30/38 9. Post-authorisation issues 9.1. Post-authorisation issues 9.1.1. Fluad Tetra – Influenza vaccine (surface antigen, inactivated, adjuvanted) – EMEA/H/C/004993 Seqirus Netherlands B.V.; active immunisation against influenza in the elderly (65 years of age and older) Rapporteur: Sol Ruiz, Co-Rapporteur: Patrick Vrijlandt Scope: Withdrawal of marketing authorisation 9.1.2. Flucelvax Tetra – influenza vaccine (surface antigen, inactivated, prepared in cell cultures) – EMEA/H/C/004814 Seqirus Netherlands B.V.; prophylaxis of influenza in adults and children from 6 months of age Rapporteur: Sol Ruiz, Co-Rapporteur: Nicholas Beix Scope: Withdrawal of marketing authorisation 9.1.3. Xevudy – Sotrovimab – EMEA/H/C/005676 Glaxosmithkline Trading; treatment of coronavirus disease 2019 (COVID-19) Rapporteur: Thalia Marie Estrup Blicher, Co-Rapporteur: Ruth Kieran Scope: Withdrawal of marketing authorisation 10. Referral procedures 10.1. Procedure for Centrally Authorised products under Article 20 of Regulation (EC) No 726/2004 10.1.1. Tecovirimat SIGA - Tecovirimat - EMA/REF/0000287477 Siga Technologies Netherlands B.V. Referral Rapporteur: Finbarr Leacy, Referral Co- Rapporteur: Vilma Petrikaite Scope: List of outstanding issues / Opinion
Page 31/38 The European Commission (EC) initiated a procedure under Article 20 of Regulation (EC) No 726/2004 and requested the Agency/CHMP to assess the benefit-risk balance of Tecovirimat SIGA. The review was prompted by emerging data from clinical trials, which raised concerns about a potential lack of efficacy. These findings need to be reviewed in the context of all available data and their potential impact on the benefit-risk of Tecovirimat SIGA in its authorised indications. 10.2. Requests for CHMP Opinion under Article 5(3) of Regulation (EC) No 726/2004 No items 10.3. Procedure under Articles 5(2) and 10 of Regulation (EC) No 726/2004 No items 10.4. Disagreement between Member States on application for medicinal product (potential serious risk to public health) –under Article 29(4) of Directive 2001/83/EC No items 10.5. Harmonisation - Referral procedure under Article 30 of Directive 2001/83/EC No items 10.6. Community Interests - Referral under Article 31 of Directive 2001/83/EC 10.6.1. Sodium oxybate syrup and oral solution for alcohol dependence - EMA/REF/0000278933 Various Referral Rapporteur: John Joseph Borg, Referral Co- Rapporteur: Nicolas Beix Scope: List of outstanding issues / Opinion Procedure triggered by France (ANSM) requesting CHMP to issue an opinion on the benefit- risk balance of sodium oxybate-containing syrup and oral solution for the treatment of alcohol dependence in authorised products and pending marketing authorisation application (s) due to concerns about efficacy and the risks of abuse and misuse.
Page 32/38 10.7. Re-examination Procedure under Article 32(4) of Directive 2001/83/EC No items 10.8. Procedure under Article 107(2) of Directive 2001/83/EC No items 10.9. Disagreement between Member States on Type II variation– Arbitration procedure initiated by MAH under Article 6(13) of Commission Regulation (EC) No 1084/2003 No items 10.10. Procedure under Article 29 of Regulation (EC) 1901/2006 No items 10.11. Referral under Article 13 Disagreement between Member States on Type II variation– Arbitration procedure initiated by Member State under Article 13 (EC) of Commission Regulation No 1234/2008 No items 11. Pharmacovigilance issue 11.1. Early Notification System February 2026 Early Notification System on envisaged CHMP/CMDh outcome accompanied by communication to the general public. 12. Inspections 12.1. GMP inspections Information related to GMP inspections will not be published as it undermines the purpose of such inspections. 12.2. GCP inspections Information related to GCP inspections will not be published as it undermines the purpose of such inspections.
Page 33/38 12.3. Pharmacovigilance inspections Information related to Pharmacovigilance inspections will not be published as it undermines the purpose of such inspections. 12.4. GLP inspections Information related to GLP inspections will not be published as it undermines the purpose of such inspections. 13. Innovation Task Force 13.1. Minutes of Innovation Task Force No items 13.2. Innovation Task Force briefing meetings Information related to briefing meetings taking place with applicants cannot be released at the present time as it is deemed to contain commercially confidential information No items 13.3. Requests for CHMP Opinion under Article 57(1)J and (1)P of Regulation (EC) No 726/2004 13.3.1. EC Request for EMA scientific opinion 13.4. Nanomedicines activities No items 14. Organisational, regulatory and methodological matters 14.1. Mandate and organisation of the CHMP 14.1.1. Vote by Proxy No items
Page 34/38 14.1.2. CHMP membership No items 14.2. Coordination with EMA Scientific Committees 14.2.1. Pharmacovigilance Risk Assessment Committee (PRAC) List of Union Reference Dates and frequency of submission of Periodic Safety Update Reports (EURD list) for February 2026. 14.2.2. Paediatric Committee (PDCO) PIPs reaching D30 at February 2026 PDCO Agenda of the PDCO meeting held on 24-27 February 2026. 14.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups 14.3.1. Biologics Working Party (BWP) Chair: Sean Barry, Vice-Chair: Andreea Barbu 14.3.2. Name Review Group (NRG) Table of Decisions of the NRG meeting held on 17-18 February 2026. 14.3.3. Scientific Advice Working Party (SAWP) Chair: Paolo Foggi, Vice-Chairs: Pierre Demolis and Ewa Balkowiec Iskra Report from the SAWP meeting held on 09-12 February 2026. Information related to scientific advice letters cannot be released at present time as these contain commercially confidential information.
Page 35/38 14.3.4. SAWP composition Chair: Paolo Foggi, Vice-Chairs: Pierre Demolis and Ewa Balkowiec Iskra SAWP composition for re-nomination. 14.4. Cooperation within the EU regulatory network No items 14.5. Cooperation with International Regulators No items 14.6. Contacts of the CHMP with external parties and interaction with the Interested Parties to the Committee No items 14.7. CHMP work plan No items 14.8. Planning and reporting No items 14.9. Others 15. Any other business 15.1. AOB topic 15.1.1. GIREX rules Analysis of requests for clock-stop extensions and feedback from GIREX. Action: For discussion
Page 36/38 Explanatory notes The notes below give a brief explanation of the main sections and headings in the CHMP agenda and should be read in conjunction with the agenda or the minutes. Oral explanations (section 2) The items listed in this section are those for which marketing authorisation holders (MAHs) or applicants have been invited to the CHMP plenary meeting to address questions raised by the Committee. Oral explanations normally relate to on-going applications (section 3, 4 and 5) or referral procedures (section 10) but can relate to any other issue for which the CHMP would like to discuss with company representatives in person. Initial applications (section 3) This section lists applications for marketing authorisations of new medicines that are to be discussed by the Committee. Section 3.1 is for medicinal products nearing the end of the evaluation and for which the CHMP is expected to adopt an opinion at this meeting on whether marketing authorisation should be granted. Once adopted, the CHMP opinion will be forwarded to the European Commission for a final legally binding decision valid throughout the EU. The other items in the section are listed depending on the stage of the evaluation, which is shown graphically below: The assessment of an application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is interrupted by at least one ‘clock-stop’ during which time the applicant prepares the answers to questions from the CHMP. The clock stop happens after day 120 and may also happen after day 180, when the CHMP has adopted a list of questions or outstanding issues to be addressed by the company. Related discussions are listed in the agenda under sections 3.2 (Day 180 List of outstanding issues) and 3.3 (Day 120 list of questions). CHMP discussions may also occur at any other stage of the evaluation, and these are listed under section 3.4, update on ongoing new applications for centralised procedures. The assessment leads to an opinion from the CHMP by day 210. Following a CHMP opinion the European Commission takes usually 67 days to issue a legally binding decision (i.e. by day 277 of the procedure). CHMP discussions on products that have received a CHMP opinion and are awaiting a decision are listed under section 3.6, products in the decision making phase.
Page 37/38 Extension of marketing authorisations according to Annex I of Reg. 1234/2008 (section 4) Extensions of marketing authorisations are applications for the change or addition of new strengths, formulations or routes of administration to existing marketing authorisations. Extension applications follow a 210-day evaluation process, similarly to applications for new medicines (see figure above). Type II variations - Extension of indication procedures (section 5) Type II variations are applications for a change to the marketing authorisation which requires an update of the product information and which is not covered in section 4. Type II variations include applications for a new use of the medicine (extension of indication), for which the assessment takes up to 90 days. For the applications listed in this section, the CHMP may adopt an opinion or request supplementary information from the applicant. Ancillary medicinal substances in medical devices (section 6) Although the EMA does not regulate medical devices it can be asked by the relevant authorities (the so-called Notified Bodies) that are responsible for regulating these devices to give a scientific opinion on a medicinal substance contained in a medical device. Re-examination procedures (new applications) under article 9(2) of regulation no 726/2004 (section 3.5) This section lists applications for new marketing authorisation for which the applicant has requested a re-examination of the opinion previously issued by the CHMP. Re-examination procedures (section5.3) This section lists applications for type II variations (including extension of indication applications) for which the applicant has requested re-examination of the opinion previously issued by the CHMP. Withdrawal of application (section 3.7) Applicants may decide to withdraw applications at any stage during the assessment and a CHMP opinion will therefore not be issued. Withdrawals are included in the agenda for information or discussion, as necessary. Procedure under article 83(1) of regulation (EC) 726/2004 (compassionate use) (section 7) Compassionate use is a way of making available to patients with an unmet medical need a promising medicine which has not yet been authorised (licensed) for their condition. Upon request, the CHMP provides recommendations to all EU Member States on how to administer, distribute and use certain medicines for compassionate use. Pre-submission issues (section 8) In some cases the CHMP may discuss a medicine before a formal application for marketing authorisation is submitted. These cases generally refer to requests for an accelerated assessment for medicines that are of major interest for public health or can be considered a therapeutic innovation. In case of an accelerated assessment the assessment timetable is reduced from 210 to 150 days. Post-authorisation issues (section 9) This section lists other issues concerning authorised medicines that are not covered elsewhere in the agenda. Issues include supply shortages, quality defects, some annual reassessments or renewals or type II variations to marketing authorisations that would require specific discussion at the plenary.
Page 38/38 Referral procedures (section 10) This section lists referrals that are ongoing or due to be started at the plenary meeting. A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. Further information on such procedures can be found here. Pharmacovigilance issues (section 11) This section lists issues that have been discussed at the previous meeting of the PRAC, the EMA’s committee responsible for evaluating and monitoring safety issues for medicines. Feedback is provided by the PRAC. This section also refers to the early notification system, a system used to notify the European regulatory network on proposed EMA communication on safety of medicines. Inspections Issues (section 12) This section lists inspections that are undertaken for some medicinal products. Inspections are carried out by regulatory agencies to ensure that marketing authorisation holders comply with their obligations. Inspection can relate to good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP) or good pharmacovigilance practice (GVP). Innovation task force (section 13) The Innovation Task Force (ITF) is a body set up to encourage early dialogue with applicants developing innovative medicines. Minutes from the last ITF meeting as well as any related issue that requires discussion with the CHMP are listed in this section of the agenda. Further information on the ITF can be found here. Scientific advice working party (SAWP) (section 14.3.1) This section refers to the monthly report from the CHMP’s Scientific Advice Working Party (SAWP) on scientific advice given to companies during the development of medicines. Further general information on SAWP can be found here. Satellite groups / other committees (section 14.2) This section refers to the reports from groups and committees making decisions relating to human medicines: the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), the Committee for Orphan Medicinal Products (COMP), the Committee for Herbal Medicinal Products (HMPC), Paediatric Committee (PDCO), the Committee for Advanced Therapies (CAT) and the Pharmamacovigilance Risk Assessment Committee (PRAC). Invented name issues (section 14.3) This section list issues related to invented names proposed by applicants for new medicines. The CHMP has established the Name Review Group (NRG) to perform reviews of the invented names. The group's main role is to consider whether the proposed names could create a public-health concern or potential safety risk. Further information can be found here. More detailed information on the above terms can be found on the EMA website: www.ema.europa.eu/
Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged. 23 February 2026 Annex to 23-26 February 2026 CHMP Agenda Pre-submission and post-authorisations issues A. PRE-SUBMISSION ISSUES ..................................................................... 2 A.1. ELIGIBILITY REQUESTS ....................................................................................... 2 A.2. Appointment of Rapporteur / Co-Rapporteur Full Applications .................................. 2 B. POST-AUTHORISATION PROCEDURES OUTCOMES ................................. 2 B.1. Annual re-assessment outcomes .......................................................................... 2 B.1.1. Annual reassessment for products authorised under exceptional circumstances ....... 2 B.2. RENEWALS OF MARKETING AUTHORISATIONS OUTCOMES ...................................... 2 B.2.1. Renewals of Marketing Authorisations requiring 2nd Renewal ................................ 2 B.2.2. Renewals of Marketing Authorisations for unlimited validity ................................... 2 B.2.3. Renewals of Conditional Marketing Authorisations ................................................ 2 B.3. POST-AUTHORISATION PHARMACOVIGILANCE OUTCOMES...................................... 2 B.5. TYPE II VARIATION, WORKSHARING PROCEDURE OUTCOMES ................................. 2 B.5.1. CHMP assessed procedures scope: Pharmaceutical aspects ................................... 3 B.5.2. CHMP assessed procedures scope: Non-Clinical and Clinical aspects ....................... 3 B.5.3. CHMP-PRAC assessed procedures ...................................................................... 3 B.5.4. PRAC assessed procedures ................................................................................ 3 B.5.5. CHMP-CAT assessed procedures ........................................................................ 3 B.5.6. CHMP-PRAC-CAT assessed procedures ............................................................... 3 B.5.7. PRAC assessed ATMP procedures ....................................................................... 3 B.5.8. Unclassified procedures and worksharing procedures of type I variations ................ 3 D. Annex D - Post-Authorisation Measures (PAMs), (Details on PAMs including description and conclusion, for adoption by CHMP in that given month, or finalised ones with PRAC recommendation and no adoption by CHMP needed) ........................................................................................... 3 E. Annex E - EMA CERTIFICATION OF PLASMA MASTER FILES ................... 3 E.1. PMF Certification Dossiers .................................................................................... 3 E.2. Timetables – starting & ongoing procedures: For information ................................... 3
Page 2/3 F. ANNEX F - Decision of the Granting of a Fee Reduction/Fee Waiver ...... 3 G. ANNEX G ................................................................................................ 3 G.1. Final Scientific Advice (Reports and Scientific Advice letters): .................................. 3 G.2. PRIME ............................................................................................................... 3 A. PRE-SUBMISSION ISSUES A.1. ELIGIBILITY REQUESTS Report on Eligibility to Centralised Procedure for February 2026: For adoption A.2. Appointment of Rapporteur / Co-Rapporteur Full Applications Final Outcome of Rapporteurship allocation for February 2026: For adoption B. POST-AUTHORISATION PROCEDURES OUTCOMES B.1. Annual re-assessment outcomes B.1.1. Annual reassessment for products authorised under exceptional circumstances B.2. RENEWALS OF MARKETING AUTHORISATIONS OUTCOMES B.2.1. Renewals of Marketing Authorisations requiring 2nd Renewal B.2.2. Renewals of Marketing Authorisations for unlimited validity B.2.3. Renewals of Conditional Marketing Authorisations B.3. POST-AUTHORISATION PHARMACOVIGILANCE OUTCOMES Signal detection PRAC recommendations on signals adopted at the PRAC meeting held on 09-12 February 2026 PRAC None B.5. TYPE II VARIATION, WORKSHARING PROCEDURE OUTCOMES Scopes related to Chemistry, Manufacturing, and Controls cannot be released at the present time as these contain commercially confidential information.
Page 3/3 B.5.1. CHMP assessed procedures scope: Pharmaceutical aspects B.5.2. CHMP assessed procedures scope: Non-Clinical and Clinical aspects B.5.3. CHMP-PRAC assessed procedures B.5.4. PRAC assessed procedures B.5.5. CHMP-CAT assessed procedures B.5.6. CHMP-PRAC-CAT assessed procedures B.5.7. PRAC assessed ATMP procedures B.5.8. Unclassified procedures and worksharing procedures of type I variations D. Annex D - Post-Authorisation Measures (PAMs), (Details on PAMs including description and conclusion, for adoption by CHMP in that given month, or finalised ones with PRAC recommendation and no adoption by CHMP needed) E. Annex E - EMA CERTIFICATION OF PLASMA MASTER FILES Information related to plasma master files cannot be released at the present time as these contain commercially confidential information. E.1. PMF Certification Dossiers E.2. Timetables – starting & ongoing procedures: For information PMF timetables starting and ongoing procedures Tabled in MMD and sent by post mail (folder E). F. ANNEX F - Decision of the Granting of a Fee Reduction/Fee Waiver G. ANNEX G G.1. Final Scientific Advice (Reports and Scientific Advice letters): Information related to Scientific Advice cannot be released at the present time as these contain commercially confidential information. G.2. PRIME Some information related to PRIME cannot be released at the present time as these contain commercially confidential information.
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