EMA CHMP Meeting Agenda March 2026

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| Committee for medicinal products for human use (CHMP) | | | | | | | | | | | |
| Annex to 23-26 March 2026 CHMP Agenda | | | | | | | | | | | |
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| 3/23/2026 | | | | | | | | | | | |
| EMA/CHMP/49808/2026 | | | | | | | | | | | |
| Human Medicines Division | | | | | | | | | | | |
| Disclaimer: 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. 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 ongoing 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). | | | | | | | | | | | |
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| Note: This document is an integral part of the March 2026 agenda. | | | | | | | | | | | |
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| For a list of acronyms and abbreviations, see: | | Abbreviations in relation to EMA regulatory activities | | | | | | **** | | | |
| Access to documents: | | EMA Policy on Access to Documents | | | | | | | | | |
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| Chair: Bruno Sepodes – Vice-Chair: Outi Mäki-Ikola | | | | | | | | | | | |
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| Cells with commercially confidential information are left blank *Classification column identifies only quality scopes. | | | | | | | | | | | |
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| Procedure | Process Type | (Invented) name | Substance(s) | Applicant | Scope* | Commettee Meeting Attribute | Classification** | Worksharing | Rapporteur | Co-Rapporteur | PRAC Rapporteur |
| Case Title (Case) (Case) | Process Type | Invented name (Case Lead Product) (Product (EMA)) | Active substance(s) (Case Lead Product) (Product (EMA)) | Customer (Case) (Case) | Precise scope (case) (Case) (Case) | Committee Meeting Attributes | relates to | Worksharing (Case) (Case) | Rapporteur (Case) (Case) | Co-Rapporteur (Case) (Case) | PRAC rapporteur (Case) (Case) |
| EMA/S/0000290089 | Annual reassessment - H | Lojuxta | Lomitapide | Chiesi Farmaceutici S.p.A. | | | | No | Patrick Vrijlandt | | Bianca Mulder |
| EMA/S/0000310527 | Annual reassessment - H | Raxone | Idebenone | Chiesi Farmaceutici S.p.A. | | | | No | John Joseph Borg | | Amelia Cupelli |
| EMA/S/0000316340 | Annual reassessment - H | Defitelio | Defibrotide | Gentium S.r.l. | | | | No | Kristina Dunder | | Mari Thorn |
| EMA/PSUR/0000311150 | PSUR | CARVYKTI | Ciltacabtagene autoleucel | Janssen Cilag International | | ATMP | | No | | | Jo Robays |
| EMA/PSUR/0000311160 | PSUR | Fycompa | Perampanel | Eisai GmbH | | | | No | | | Tiphaine Vaillant |
| EMA/PSUR/0000311141 | PSUR | Tecvayli | Teclistamab | Janssen Cilag International | | | | No | | | Veronika Macurova |
| EMA/PSUR/0000311184 | PSUR | Qdenga | DENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED) | Takeda GmbH | | | | No | | | Liana Martirosyan |
| EMA/PSUR/0000311064 | PSUR | RINVOQ | Upadacitinib | Abbvie Deutschland GmbH & Co. KG | | | | No | | | Petar Mas |
| EMA/PSUR/0000308360 | PSUR | Dengue Tetravalent Vaccine (Live, Attenuated) Takeda | DENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED) | Takeda GmbH | | | | No | | | Liana Martirosyan |
| EMA/PSUR/0000311151 | PSUR | Kapruvia | Difelikefalin | Vifor Fresenius Medical Care Renal Pharma France | | | | No | | | Mari Thorn |
| EMA/PSUR/0000311145 | PSUR | Voxzogo | Vosoritide | Biomarin International Limited | | | | No | | | Zane Neikena |
| EMA/PSUR/0000311177 | PSUR | ALTUVOCT | Efanesoctocog alfa | Swedish Orphan Biovitrum AB (publ) | | N/A | | No | | | Amelia Cupelli |
| EMA/R/0000323237 | Renewal - 1 year | Ezmekly | Mirdametinib | Springworks Therapeutics Ireland Limited | | | | No | Alexandre Moreau | | Bianca Mulder |
| EMA/R/0000317381 | Renewal - 1 year | Lytgobi | Futibatinib | Taiho Pharma Netherlands B.V. | | | | No | Peter Mol | | Mari Thorn |
| EMA/R/0000319073 | Renewal - 1 year | Rozlytrek | Entrectinib | Roche Registration GmbH | | | | No | Paolo Gasparini | | Bianca Mulder |
| EMA/R/0000316670 | Renewal - 1 year | Duvyzat | Givinostat | Italfarmaco S.p.A. | | | | No | Janet Koenig | | Liana Martirosyan |
| EMA/R/0000319964 | Renewal - 1 year | Aucatzyl | Obecabtagene autoleucel | Autolus GmbH | | | | No | Berendina Maria van den Hoorn | | Karin Erneholm |
| EMA/R/0000314834 | Renewal - 5 year | Fingolimod Mylan | Fingolimod | Mylan Pharmaceuticals Limited | | | | No | Kristina Nadrah | | Tiphaine Vaillant |
| EMA/R/0000316559 | Renewal - 5 year | Cometriq | Cabozantinib | Ipsen Pharma | | | | No | Peter Mol | Ingrid Wang | Bianca Mulder |
| EMA/R/0000314604 | Renewal - 5 year | Voxzogo | Vosoritide | Biomarin International Limited | First 5-years renewal | | | No | Janet Koenig | Christian Gartner | Zane Neikena |
| EMA/VR/0000308170 | Variation type IB | Bylvay KAYFANDA | Odevixibat Odevixibat | Ipsen Pharma | | | Quality | Yes | Patrick Vrijlandt | | |
| EMA/VR/0000314304 | Variation type IB | Imatinib Teva | Imatinib | Teva B.V. | C.I.2.a - to update section 4.5 of SmPC with new paragraph related to interaction with Methotrexate. Following changes of reference product texts Glivec (EMA/VR/0000290092) sections 4.2, 4.8 and 5.1 of the SmPC (reordering of text) and Sections 3 and 6 of PL were updated. The MAH took also the opportunity to apply the following additional changes: • Adaption to the latest QRD-template; • Minor editorial changes (format changes, e.g. spacing or indentation, correcting typos, reordering of text) For EMEA/H/C/002585 only: • Changes within list of local representatives in section 6 of the PL for: MT, ES and deletion of UK(NI); • Minor editorial changes in translations for EL, HU and MT. | | | Yes | Carolina Prieto Fernandez | | |
| EMA/VR/0000327271 | Variation type IB | Ranivisio Epruvy | Ranibizumab Ranibizumab | Midas Pharma GmbH | | | Quality | Yes | Jan Mueller-Berghaus | | |
| EMA/VR/0000313630 | Variation type IB | Ranivisio Epruvy | Ranibizumab Ranibizumab | Midas Pharma GmbH | | | Quality | Yes | Jan Mueller-Berghaus | | |
| EMA/VR/0000285852 | Variation type IB | Xarelto | Rivaroxaban | Bayer AG | | | Quality | Yes | Kristina Dunder | | |
| EMA/VR/0000310736 | Variation type IB | Forxiga Xigduo Qtern Edistride Ebymect | Dapagliflozin Dapagliflozin / Metformin Saxagliptin / Dapagliflozin Dapagliflozin Dapagliflozin / Metformin | AstraZeneca AB | C.I.3.z - to update section 4.4 of the SmPC following the CHMP conclusion dated 16 October 2025 using the PRAC agreed wording to conclude the PAM (LEG) procedure (EMA/PAM/0000289605). | | | Yes | Kristina Dunder | | |
| EMA/VR/0000310403 | Variation type IB | Lenalidomide Krka | Lenalidomide | KRKA tovarna zdravil d.d. Novo mesto | C.I.11.z - to update Annex IID and the RMP following the outcome of the renewal procedure (EMA/R/0000272358). The RMP has been updated in accordance with the changes to the reference product's RMP as requested. | | | Yes | Andreja Kranjc | | Tiphaine Vaillant |
| EMA/VR/0000323424 | Variation type IB | Trulicity Cyramza Taltz Emgality Omvoh Kisunla | Dulaglutide Ramucirumab Ixekizumab Galcanezumab Mirikizumab Donanemab | Eli Lilly Nederland B.V. Eli Lilly Nederland B.V. Eli Lilly and Co (Ireland) Limited Eli Lilly Nederland B.V. Eli Lilly Nederland B.V. Eli Lilly Nederland B.V. | | | Quality | Yes | Janet Koenig | | |
| EMA/VR/0000325497 | Variation type IB | Lixiana Roteas | Edoxaban Edoxaban | Daiichi Sankyo Europe GmbH Berlin-Chemie AG | | | Quality | Yes | Antonio Gomez-Outes | | |
| EMA/VR/0000324776 | Variation type IB | Binocrit Epoetin alfa Hexal Abseamed | Epoetin alfa Epoetin alfa Epoetin alfa | Sandoz GmbH H e x a l AG Medice Arzneimittel Puetter GmbH & Co. KG | | | Quality | Yes | Alexandre Moreau | | |
| EMA/VR/0000314312 | Variation type IB | Cometriq CABOMETYX | Cabozantinib Cabozantinib | Ipsen Pharma | | | Quality | Yes | Ingrid Wang | | |
| EMA/VR/0000310964 | Variation type IB | Insuman Lantus Toujeo Apidra | Insulin human Insulin glargine Insulin glargine Insulin glulisine | Sanofi-Aventis Deutschland GmbH | C.z – to update section 4.9 of the SmPC by removing the route of administration of glucagon in the PIs of insulin-containing medicinal products. The same rationale applies in section Hyperglycaemia and Hypoglycaemia of the Package Leaflet (What should you do if you experience hypoglycaemia). Additionally, the applicant takes the opportunity to reinstate the below texts for Apidra and Lantus (“Other side effects” section), which is the standard template sentence on "Other side effects" in PL, and that were omitted inadvertently in the PL: “Tell your doctor, pharmacist or nurse if you notice any of the following side effects:” Furthermore, the MAH has made some minor editorial corrections and formatting changes in the English SmPC and Package Leaflet of Lantus, Toujeo and Apidra. Finally, the MAH also takes the opportunity to update the local representative information in the Package Leaflet as follows: • Apidra: UK-NI (deletion) and Iceland (name change) and Italy (telephone number change). • Lantus: UK-NI (deletion) and Iceland (name change) and Italy (telephone number change). • Toujeo: Italy (telephone number change). • Insuman: Italy (telephone number change: adding the international country code as(+39)). | | | Yes | Karin Janssen van Doorn | | |
| EMA/VR/0000327316 | Variation type IB | Baiama Ahzantive | Aflibercept Aflibercept | Formycon AG | | | Quality | Yes | Tomas Radimersky | | |
| EMA/VR/0000300752 | Variation type IB | Febuxostat Krka | Febuxostat | KRKA tovarna zdravil d.d. Novo mesto | | | Quality | Yes | John Joseph Borg | | |
| EMA/VR/0000315651 | Variation type IB | Hexacima Hexyon | diphtheria, tetanus, pertussis (acellular, component), hepatitis b (rdna), poliomyelitis (inact.) and haemophilus type b conjugate vaccine (adsorbed)// diphtheria, tetanus, pertussis (acellular, component), hepatitis b (rdna), poliomyelitis (inact.) and haemophilus type b conjugate vaccine (adsorbed) | Sanofi Winthrop Industrie | | | Quality | Yes | Jan Mueller-Berghaus | | |
| EMA/VR/0000328217 | Variation type IB | Lenvima Kisplyx | Lenvatinib Lenvatinib | Eisai GmbH | C.3.b - to update section 4.8 of the EN SmPC, resulting from the final assessment report, dated 11 December 2025, for paediatric study E7080-G000-231, which was submitted in accordance with Article 46 of regulation (EC) No 1901/2006 (Procedure no.: EMA/PAM/0000279817 and EMA/PAM/0000279841). | | | Yes | Karin Janssen van Doorn | | |
| EMA/VR/0000325499 | Variation type IB | Lixiana Roteas | Edoxaban Edoxaban | Daiichi Sankyo Europe GmbH Berlin-Chemie AG | | | Quality | Yes | Antonio Gomez-Outes | | |
| EMA/VR/0000320740 | Variation type II | Padcev | Enfortumab vedotin | Astellas Pharma Europe B.V. | | | Quality | No | Thalia Marie Estrup Blicher | | |
| EMA/VR/0000321341 | Variation type II | IMULDOSA | Ustekinumab | Accord Healthcare S.L.U. | | | Quality | No | Ruth Kieran | | |
| EMA/VR/0000321396 | Variation type II | ROMVIMZA | Vimseltinib | Deciphera Pharmaceuticals (Netherlands) B.V. | Update of section 4.5 of the SmPC in order to add drug-drug interaction information with P-gp substrates based on pharmacokinetic modelling and simulation; the Package Leaflet is updated accordingly. | | | No | Martin Mengel | | |
| EMA/VR/0000319629 | Variation type II | Cyanokit | Hydroxocobalamin | Serb | | | Quality | No | Alexandre Moreau | | |
| EMA/VR/0000320815 | Variation type II | Rezdiffra | Resmetirom | Madrigal Pharmaceuticals EU Limited | A grouped application consisting of: C.I.13: Submission of the final report from study MGL-3196-21. This is phase 1, multi-center, open-label study to evaluate the pharmacokinetics, safety, and tolerability of multiple oral doses (6 days) of 100 mg resmetirom in subjects with severe renal impairment and in matched healthy control subjects with normal renal function. C.I.13: Submission of the final report from study MGL-3196-24. This is a phase 1, single-center, open-label, drug interaction study of resmetirom with rosuvastatin in healthy subjects. | | | No | Janet Koenig | | |
| EMA/VR/0000320482 | Variation type II | Dupixent | Dupilumab | Sanofi Winthrop Industrie | Update of section 5.1 of the SmPC in order to update clinical efficacy information based on final results from the phase 4 study LPS15834 (VESTIGE); this is a 24-week multicenter, randomized, double-blind, placebo-controlled, parallel group global phase IV study evaluating the effect of dupilumab on airway inflammation and structural changes in patients with moderate to severe type 2 asthma. In addition, the MAH took the opportunity to introduce additional changes to the Instructions for Use section. | | | No | Jan Mueller-Berghaus | | |
| EMA/VR/0000264105 | Variation type II | Arava | Leflunomide | Sanofi-Aventis Deutschland GmbH | Submission of an updated RMP version 6.0 in order to address query raised by PRAC EMEA/H/C/PSUSA/00001837/202309 on the effectiveness and usefulness of the additional risk minimization measures (aRMMs) specifically related to the safety concerns hepatic reactions, blood cytopenia, and infections. | | | No | Peter Mol | | Liana Martirosyan |
| EMA/VR/0000315759 | Variation type II | Ruxience | Rituximab | Pfizer Europe MA EEIG | | | Quality | No | Peter Mol | | |
| EMA/VR/0000316398 | Variation type II | Ziihera | Zanidatamab | Jazz Pharmaceuticals Ireland Limited | Update of sections 5.1, and 5.2 of the SmPC in order to update pharmacokinetic information based on final results from study ZW25-ZW1-101 and PopPK analysis. Study 101 is a phase 1 trial of ZW25 in patients with locally advanced (unresectable) and/or metastatic HER2-expressing cancers. In addition, the MAH took the opportunity to introduce editorial changes to the PI. | | | No | Thalia Marie Estrup Blicher | | |
| EMA/VR/0000320821 | Variation type II | Flucelvax | influenza vaccine (surface antigen, inactivated, prepared in cell cultures) | Seqirus Netherlands B.V. | | | Quality | No | Sol Ruiz | | |
| EMA/VR/0000322828 | Variation type II | Qoyvolma | Ustekinumab | Celltrion Healthcare Hungary Kft. | | | Quality | No | Ruth Kieran | | |
| EMA/VR/0000293786 | Variation type II | Hexacima Hexyon | diphtheria, tetanus, pertussis (acellular, component), hepatitis b (rdna), poliomyelitis (inact.) and haemophilus type b conjugate vaccine (adsorbed)// diphtheria, tetanus, pertussis (acellular, component), hepatitis b (rdna), poliomyelitis (inact.) and haemophilus type b conjugate vaccine (adsorbed) | Sanofi Winthrop Industrie | | | Quality | Yes | Jan Mueller-Berghaus | | |
| EMA/VR/0000303055 | Variation type II | Epidyolex | Cannabidiol | Jazz Pharmaceuticals Ireland Limited | A grouped application consisting of: C.I.4: Update of section 5.3 of the SmPC in order to add information about genotoxicity based on final results from study GWTX21060 following EU Letter of Recommendations, agreed during the initial MAA. This study concerns embryo-fetal development in the rat. The MAH also included updates to the Multiples of Human Exposure detailed in the non-clinical data included in section 5.3 of the SmPC. In addition, the MAH took the opportunity to introduce editorial changes to the PI. C.I.4: Update of section 5.3 of the SmPC in order to add information about genotoxicity based on final results from study GWTX21062 following EU Letter of Recommendations, agreed during the initial MAA. This study concerns a pre- and postnatal development study in rat. C.I.13: Submission of the final report from genotoxicity study JZP926-TX-1495 concerning cytogenic test for chromosomal damage following EU Letter of Recommendations, agreed during the initial MAA. C.I.13: Submission of the final report from genotoxicity study JZP926-TX-1805 concerning rat bone marrow micronucleus assay following EU Letter of Recommendations, agreed during the initial MAA. | | | No | Thalia Marie Estrup Blicher | | |
| EMA/VR/0000289986 | Variation type II | Flebogamma DIF | Human normal immunoglobulin | Instituto Grifols S.A. | | | Quality | Yes | Jan Mueller-Berghaus | | |
| EMA/VR/0000313332 | Variation type II | Ezmekly | Mirdametinib | Springworks Therapeutics Ireland Limited | A grouped application consisting of: C.I.4: Update of section 5.2 of the SmPC in order to introduce the results from the in vitro study KC245128 investigating the reversible inhibitory potential of mirdametinib and PD-0315209 on CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP2D6, and CYP3A4. C.I.4: Update of section 5.2 of the SmPC in order to introduce the results from the in vitro study KC255037 investigating the potential inhibitory effect of PD-0315209 on UGT enzymes. C.I.4: Update of section 5.2 of the SmPC in order to introduce the results from the in vitro studies KC245140 and KC248110 investigating the CYP enzyme and transporter inhibitory potential of M22. C.I.13: Submission of the final report from the in vitro study KC255048 conducted to determine the mirdametinib Ki and Kinact for CYP2C19. C.I.13: Submission of the final report from from the in vitro investigation SPWT-20250515B (IVBU) of the pharmacological activity of M30. | | | No | Alexandre Moreau | | |
| EMA/VR/0000304947 | Variation type II | Korjuny | Catumaxomab | Atnahs Pharma Netherlands B.V. | Submission of the final report from study concerning the validation of quantification of EpCAM-positive cells in malignant ascites samples for EpCAM CytoDetect Assay implementation using HO-3 primary anti-body to fulfil commitment given during the Marketing Authorisation Application (EMEA/H/C/005697). | | | No | Jan Mueller-Berghaus | | |
| EMA/VR/0000312940 | Variation type II | Darzalex | Daratumumab | Janssen Cilag International | Update of section 4.2 of the SmPC in order to introduce, upon physician’s discretion, the possibility of self-administration of Darzalex SC by patients or their caregivers, based on results from four human factor studies. The Package Leaflet is updated accordingly. In addition, the Labelling section is updated to include information in Braille. | | | No | Thalia Marie Estrup Blicher | | |
| EMA/VR/0000296242 | Variation type II | Doptelet | Avatrombopag | Swedish Orphan Biovitrum AB (publ) | A grouped application consisting of: C.I.11 for RMP: Submission of an updated RMP version 4.0 to propose the removal of missing information Use in splenectomy patients with chronic liver disease, Use in patients receiving interferon products and Safety in patients undergoing invasive procedures. C.I.11 for RMP: Submission of an updated RMP version 4.0 to propose to remove Targeted Medical Event Questionnaires. C.I.11 for RMP: Submission of an updated RMP version 4.0 to update information on immune thrombocytopenia (ITP) PASS and chronic liver disease (CLD) PASS studies. | | | No | | | Maria Martinez Gonzalez |
| EMA/VR/0000315906 | Variation type II | Remsima | Infliximab | Celltrion Healthcare Hungary Kft. | | | Quality | No | Outi Mäki-Ikola | | |
| EMA/VR/0000320822 | Variation type II | Orkambi | Lumacaftor / Ivacaftor | Vertex Pharmaceuticals (Ireland) Limited | Submission of the final report from study VX18-809-128 (study 128), listed as an obligation in the Annex II of the Product Information. This is a 6-year, observational, post-authorization efficacy study (PAES) in young children with cystic fibrosis (CF) aged 1 through 5 years at the time of Orkambi initiation. This study evaluated disease progression and safety using observational cohorts of children receiving therapy in a “real-world” setting. The Annex II and the RMP version 12.0 are updated accordingly. | | | No | Paolo Gasparini | | Eamon O Murchu |
| EMA/VR/0000320811 | Variation type II | Darzalex | Daratumumab | Janssen Cilag International | | | Quality | No | Thalia Marie Estrup Blicher | | |
| EMA/VR/0000308742 | Variation type II | Ilumetri | Tildrakizumab | Almirall S.A. | Update of section 5.1 of the SmPC with efficacy data of nail psoriasis based on final results from study TILD-18-19; this is a phase 3 b, multicenter, randomized, double-blind, placebo-controlled clinical study to assess the efficacy and safety of tildrakizumab in the treatment of moderate-to-severe nail psoriasis. | | | No | Jan Mueller-Berghaus | | |
| EMA/VR/0000304280 | Variation type II | Dazublys | Trastuzumab | Curateq Biologics s.r.o. | | | Quality | No | Jan Mueller-Berghaus | | |
| EMA/VR/0000315088 | Variation type II | Erbitux | Cetuximab | Merck Europe B.V. | | | Quality | No | Filip Josephson | | |
| EMA/VR/0000315350 | Variation type II | Omlyclo | Omalizumab | Celltrion Healthcare Hungary Kft. | | | Quality | No | Finbarr Leacy | | |
| EMA/VR/0000301995 | Variation type II | Flucelvax | influenza vaccine (surface antigen, inactivated, prepared in cell cultures) | Seqirus Netherlands B.V. | | | Quality | No | Sol Ruiz | | |
| EMA/VR/0000309688 | Variation type II | Visudyne | Verteporfin | Cheplapharm Arzneimittel GmbH | | | Quality | No | Alexandre Moreau | | |
| EMA/VR/0000309145 | Variation type II | Itovebi | Inavolisib | Roche Registration GmbH | Grouped application comprised of a Type II Variation and a Type IA Variation, as follows: Type II (C.I.4): Update of sections 4.2 and 5.2 of the SmPC in order to update posology recommendations for patients with severe renal impairment and to update pharmacokinetics information based on final results from study GP44944; this is a Phase I, open-label, multicenter, single-dose, parallel-group study to evaluate the effect of moderate or severe renal impairment on the pharmacokinetics, safety, and tolerability of a single oral dose of 6 mg inavolisib compared with demographically matched healthy subjects with normal renal function. In addition, the MAH took the opportunity to introduce minor corrections and formatting changes to the PI. Type IA (A.6): To include the ATC Code L01EM06 in section 5.1 of the SmPC. | | | No | Filip Josephson | | |
| EMA/VR/0000307073 | Variation type II | Perjeta | Pertuzumab | Roche Registration GmbH | Update of sections 4.8 and 5.1 of the SmPC in order to update safety and efficacy data, based on final results from post-authorisation efficacy study BO25126 (APHINITY) listed as a specific obligation in the Annex II; this is a phase III, randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer; the Package Leaflet and Annex II are updated accordingly. The RMP version 15.0 has also been submitted. In addition, the MAH took the opportunity to introduce editorials changes to the PI. | | | No | Thalia Marie Estrup Blicher | | Marie Louise Schougaard Christiansen |
| EMA/VR/0000315309 | Variation type II | Kisqali | Ribociclib | Novartis Europharm Limited | Update of sections 4.2, 5.1, and 5.2 of the SmPC in order to update information on paediatric population based on the final results from the study CLEE011Q12101 listed as study 3 of the PIP EMEA-002765-PIP02-21-M01 for Kisqali; this is a Phase I/II interventional study CLEE011Q12101 designed to determine a safe dose and treatment schedule of ribociclib when combined with TOTEM, with an aim to provide a therapeutic opportunity for pediatric patients with high unmet medical need, especially those with relapsed or refractory high-risk Neuroblastoma. | | | No | Filip Josephson | | |
| EMA/VR/0000316217 | Variation type II | Adjupanrix | Pandemic influenza vaccine, monovalent (split virion, inactivated, adjuvanted) | GlaxoSmithKline Biologicals | | | Quality | No | Patrick Vrijlandt | | |
| EMA/VR/0000321405 | Variation type II | Kinpeygo | Budesonide | STADA Arzneimittel AG | Update of sections 4.2, 4.8 and 5.1 of the SmPC in order to update efficacy and safety information regarding re-treatment, based on results from the Phase 3b Nef-301 OLE study. This is an Open-Label Extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgA nephropathy who have completed study Nef-301. In addition, the MAH took the opportunity to introduce minor formatting changes to the PI. | | | No | Christian Gartner | | |
| EMA/VR/0000302930 | Variation type II | Twinrix Adult Twinrix Paediatric Ambirix | HEPATITIS A (INACTIVATED) AND HEPATITIS B (RDNA) VACCINE (ADSORBED)// HEPATITIS A (INACTIVATED) AND HEPATITIS B (RDNA) VACCINE (ADSORBED)// HEPATITIS A (INACTIVATED) AND HEPATITIS B (RDNA) VACCINE (ADSORBED) | GlaxoSmithKline Biologicals | | | Quality | Yes | Christophe Focke | | |
| EMA/VR/0000325758 | Variation type II | SARCLISA | Isatuximab | Sanofi Winthrop Industrie | Update of sections 4.4 and 4.8 of the SmPC in order to update information regarding anaphylactic reactions including fatal events, based on recent post-marketing surveillance data. The Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to include minor editorial changes and to update the list of local representatives in the Package Leaflet. | | | No | Peter Mol | | |
| EMA/VR/0000332468 | Variation type II | Visudyne | Verteporfin | Cheplapharm Arzneimittel GmbH | | | Quality | No | Alexandre Moreau | | |
| EMA/VR/0000319546 | Variation type II | Strensiq | Asfotase alfa | Alexion Europe | | | Quality | No | Paolo Gasparini | | |
| EMA/VR/0000310706 | Variation type II | Perjeta | Pertuzumab | Roche Registration GmbH | | | Quality | No | Thalia Marie Estrup Blicher | | |
| EMA/VR/0000319537 | Variation type II | PHELINUN | Melphalan | Adienne S.r.l. | | | Quality | No | Peter Mol | | |
| EMA/VR/0000319763 | Variation type II | COMIRNATY | COVID-19 mRNA vaccine | BioNTech Manufacturing GmbH | | | Quality | No | Filip Josephson | | |
| EMA/VR/0000320506 | Variation type II | Ponvory | Ponesimod | Laboratoires Juvise Pharmaceuticals | Submission of the final report from non-interventional post authorisation safety study PCSNSP003693 listed as a category 3 study in the RMP. This is a Survey to Assess the Effectiveness of Ponvory Educational Materials for Additional Risk Minimization Measures in the European Union. | | | No | | | Karin Erneholm |
| EMA/VR/0000312915 | Variation type II | Hemangiol | Propranolol | Pierre Fabre Medicament | A grouped application comprised of 3 Type II Variations, as follows: C.I.4: Update of sections 4.2 and 4.4 of the SmPC in order to delete the monitoring in relation to cardiovascular parameters after each dose increase, based on a comprehensive safety review. The Package Leaflet is updated accordingly. C.I.4: Update of sections 4.2 and 5.1 of the SmPC in order to update the percentage of patients showing relapse of symptoms after treatment discontinuation. C.I.4: Update of section 4.4 of the SmPC in order to update the existing warning on ‘PHACE syndrome’, based on literature data. In addition, the MAH took the opportunity to introduce changes to the PI, including additions, clarifications, corrections and formatting changes in line with the guidance. | | | No | Nicolas Beix | | |
| EMA/VR/0000320413 | Variation type II | Kaftrio | Ivacaftor / Tezacaftor / Elexacaftor | Vertex Pharmaceuticals (Ireland) Limited | Submission of Part A (week 96) clinical study report for study VX21-445-125 (study 125). This is a Phase 3, open-label study to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in cystic fibrosis (CF) subjects ≥6 years of age who have qualifying non-F508del ELX/TEZ/IVA-responsive CFTR mutations. RMP version 10.3 has also been submitted. | | | No | Peter Mol | | Dennis Lex |
| EMA/VR/0000320816 | Variation type II | Remsima | Infliximab | Celltrion Healthcare Hungary Kft. | | | Quality | No | Outi Mäki-Ikola | | |
| EMA/VR/0000319148 | Variation type II | Nulojix | Belatacept | Bristol-Myers Squibb Pharma EEIG | | | Quality | No | Filip Josephson | | |
| EMA/VR/0000319887 | Variation type II | Kaftrio | Ivacaftor / Tezacaftor / Elexacaftor | Vertex Pharmaceuticals (Ireland) Limited | Submission of the final report from the 5-year Post Authorisation Safety Study (PASS) VX20-445-120, listed as a category 3 study in the RMP. This is a longitudinal, registry based study evaluating the real-world effects and utilisation patterns of elexacaftor, tezacaftor, and ivacaftor combination therapy (ELX/TEZ/IVA) in patients with cystic fibrosis (CF). The RMP version 10.2 has also been submitted. | | | No | | | Dennis Lex |
| EMA/VR/0000320809 | Variation type II | Avonex | Interferon beta-1A | Biogen Netherlands B.V. | Update of section 5.1 of the SmPC following the outcome of procedure PAM/0000245472, based on interim results from study 105MS306 (CHARGE). This is an open-label, randomized, multicenter, active-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of BIIB017 in pediatric subjects aged 10 to less than 18 years for the treatment of relapsing-remitting multiple sclerosis, with optional open-label extension. | | | No | Antonio Gomez-Outes | | |
| EMA/VR/0000316395 | Variation type II | Dexdor | Dexmedetomidine | Orion Corporation | Submission of the final report from study ANZIC-RC/YS003 listed as a category 3 PASS in the RMP. It concerns sedation practice in intensive care evaluation [SPICE] III, early goal directed sedation compared with standard care in mechanically ventilated patients in intensive care. The RMP version 10.0 has also been submitted. | | | No | | | Karin Bolin |
| EMA/VR/0000319745 | Variation type II | Winrevair | Sotatercept | Merck Sharp & Dohme B.V. | | | Quality | No | Patrick Vrijlandt | | |
| EMA/VR/0000319297 | Variation type II | Mosquirix | PLASMODIUM FALCIPARUM AND HEPATITIS B VACCINE (RECOMBINANT, ADJUVANTED) | GlaxoSmithKline Biologicals | A grouped application consisting of: C.I.13: Submission of the final report from post authorisation safety study EPI-MAL-005 listed as a category 3 study in the RMP. This is an epidemiology study to assess Plasmodium falciparum parasite prevalence and malaria control measures in catchment areas of two interventional studies pre- and post RTS,S/AS01E introduction (EPI-MAL-002 and EPI-MAL-003) to assess, in field conditions, vaccine benefit:risk in children in sub-Saharan Africa. RMP version 7.0 has also been submitted. C.I.13: Submission of the final report from post authorisation safety study EPI-MAL-010 listed as a category 3 study in the RMP. This is a phase IV, longitudinal, cross-sectional, retrospective, ancillary epidemiology study of the EPI-MAL-005 study to evaluate the genetic diversity in the Plasmodium falciparum parasite circumsporozoite sequences before and after the implementation of the RTS,S/AS01E vaccine in malaria-positive subjects ranging from 6 months to less than 5 years of age. | | | No | | | Jean-Michel Dogné |
| EMA/VR/0000322540 | Variation type II | Lantus | Insulin glargine | Sanofi-Aventis Deutschland GmbH | | | Quality | No | Patrick Vrijlandt | | |
| EMA/VR/0000320529 | Variation type II | IXCHIQ | Chikungunya vaccine (live) | Valneva Austria GmbH | | | Quality | No | Christophe Focke | | |
| EMA/VR/0000319771 | Variation type II | Spectrila | Asparaginase | Medac Gesellschaft für klinische Spezialpräparate mbH | | | Quality | No | Christian Gartner | | |
| EMA/VR/0000319709 | Variation type II | Pylclari | Piflufolastat (18F) | Curium Pet France | Update of sections 4.4 and 5.1 of the SmPC in order to include a CE-marked software as an adjunct to the visual interpretation for standardized reporting and semi-quantitative assessment based on literature. | | | No | Antonio Gomez-Outes | | |
| EMA/VR/0000322246 | Variation type II | Flixabi | Infliximab | Samsung Bioepis NL B.V. | | | Quality | No | Jan Mueller-Berghaus | | |
| EMA/VR/0000317717 | Variation type II | Nuvaxovid | COVID-19 vaccine (recombinant, adjuvanted) | Sanofi Winthrop Industrie | A grouped application consisting of: Type II (C.I.4): Update of sections 4.8 and 5.1 of the SmPC in order to update safety and pharmacokinetic information based on final results from study 2019nCoV-301 (adolescent part). This is a Phase 3, Randomized, Observer-Blinded, Placebo Controlled Study To Evaluate The Efficacy, Safety, And Immunogenicity Of A Sars-Cov-2 Recombinant Spike Protein Nanoparticle Vaccine (Sars-Cov-2 Rs) With Matrix-M1™ Adjuvant In Adult Participants ≥ 18 Years With A Pediatric Expansion In Adolescents (12 To < 18 Years). The Package Leaflet is updated accordingly. Type II (C.I.4): Update of sections 4.8 and 5.1 of the SmPC in order to update safety and pharmacokinetic information based on final results from study 2019nCoV-311 part 2. This is a Multi-Part, Phase 3, Randomized, Observer Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adults Previously Vaccinated with Other COVID-19 Vaccines. The Package Leaflet is updated accordingly. Type IB (C.I.z): to update the PI in accordance with the latest EMA excipients guideline. | | | No | Patrick Vrijlandt | | |
| EMA/VR/0000319983 | Variation type II | Beyfortus | Nirsevimab | Sanofi Winthrop Industrie | | | Quality | No | Thalia Marie Estrup Blicher | | |
| EMA/VR/0000320218 | Variation type II | Olumiant | Baricitinib | Eli Lilly Nederland B.V. | A grouped application consisting of: C.I.4: Update of sections 4.2 and 5.1 of the SmPC based on long-term efficacy data from Study I4V-MC-JAHO in adults with alopecia areata. This is a Multicentre, Randomised, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Severe or Very Severe Alopecia Areata. C.I.4: Update of sections 4.2 and 5.1 of the SmPC based on long-term efficacy data from Study I4V-MC-JAIR in adults with alopecia areata. This is a Multicentre, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Participants with Severe or Very Severe Alopecia Areata. | | | No | Peter Mol | | |
| EMA/VR/0000320170 | Variation type II | Evenity | Romosozumab | UCB Pharma | Submission of the final report of the EU PASS study OP0006 listed as a category 3 study in the RMP. The OP0006 EU PASS study is a European non-interventional post authorization safety study related to serious infections for romosozumab. The RMP version 3.0 has also been submitted. | | | No | | | Tiphaine Vaillant |
| EMA/VR/0000316339 | Variation type II | Nemluvio | Nemolizumab | Galderma International | A grouped application comprised of two Type II Variations, as follows: C.I.4: Update of sections 4.8 and 5.1 of the SmPC in order to update clinical safety and efficacy information based on interim results from the ARCADIA long-term extension (LTE) study (RD.06.SIR.118163) listed as a category 3 study in the RMP; this is a Phase 3 prospective, multicenter, open-label, long-term extension study evaluating the long-term safety and efficacy of nemolizumab in adolescent and adult subjects with moderate-to-severe atopic dermatitis (AD). C.I.4: Update of sections 4.8 and 5.1 of the SmPC in order to update clinical safety and efficacy information based on interim results from the OLYMPIA long-term extension (LTE) study (RD.06.SIR.202699) listed as a category 3 study in the RMP; this is a Phase 3 prospective, multicenter, open-label, long-term extension study evaluating the long-term safety and efficacy of nemolizumab in adult subjects with moderate-to-severe prurigo nodularis (PN). | | | No | Kristina Dunder | | |
| EMA/VR/0000320475 | Variation type II | Orencia | Abatacept | Bristol-Myers Squibb Pharma EEIG | | | Quality | No | Outi Mäki-Ikola | | |
| EMA/VR/0000294539 | Variation type II | Ovaleap | Follitropin alfa | Theramex Ireland Limited | | | Quality | No | Patrick Vrijlandt | | |
| EMA/VR/0000295392 | Variation type II | Ozempic Rybelsus | Semaglutide Semaglutide | Novo Nordisk A/S | Update of section 4.4 of the SmPC in order to remove of Type 1 diabetes mellitus restriction from warnings and precautions based on a post-marketing safety assessment of off-label/T1D use for Ozempic and Rybelsus; the Package Leaflet is updated accordingly. | | | Yes | Patrick Vrijlandt | | |
| EMA/VR/0000321440 | Variation type II | LEQEMBI | Lecanemab | Eisai GmbH | Update of sections 4.2 and 5.1 of the SmPC in order to introduce a new posology regimen based on model-based simulations derived from all observed data from intravenous lecanemab studies and long-term safety data. The Package Leaflet has been updated accordingly. | | | No | Alexandre Moreau | | |
| EMA/VR/0000287898 | Variation type II | Orencia | Abatacept | Bristol-Myers Squibb Pharma EEIG | A grouped application consisting of: C.I.13: Submission of the final report from study IM101803 listed as a category 3 study in the RMP. This is a nationwide post-marketing study on the safety of abatacept treatment in Denmark using the DANBIO register. The RMP version 29.0 has also been submitted. C.I.13: Submission of the final report from study IM101816 listed as a category 3 study in the RMP. This is a nationwide post-marketing study on the safety of abatacept treatment in Sweden using the ARTIS Register. The RMP version 29.0 has also been submitted. | | | No | | | Kimmo Jaakkola |
| EMA/VR/0000317563 | Variation type II | RINVOQ | Upadacitinib | Abbvie Deutschland GmbH & Co. KG | Submission of the final report for study M15-572, listed as a category 3 study in the RMP. This is a Phase 3, randomized, double-blind study comparing upadacitinib (ABT-494) to placebo and to adalimumab in subjects with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic disease modifying anti-rheumatic drug (DMARD) – (SELECT – PsA 1). | | | No | Kristina Dunder | | |
| EMA/VR/0000322786 | Variation type II | Yesafili | Aflibercept | Biosimilar Collaborations Ireland Limited | | | Quality | No | Christian Gartner | | |
| EMA/VR/0000319301 | Variation type II | Nuvaxovid | COVID-19 vaccine (recombinant, adjuvanted) | Sanofi Winthrop Industrie | Submission of the final report from study 2019nCov-401 listed as a category 3 study in the RMP. This is a post-authorisation effectiveness study titled: “Brand-specific COVID-19 vaccine effectiveness of Novavax’s COVID- 19 Vaccines against severe COVID-19 in Europe: a non-investigational study to continuously monitor COVID-19 vaccine effectiveness of the updated Novavax JN.1 COVID-19 vaccine (NVX-CoV2705) against hospitalisation using a network of hospitals across Europe.” | | | No | Patrick Vrijlandt | | |
| EMA/VR/0000320544 | Variation type II | Livmarli | Maralixibat | Mirum Pharmaceuticals International B.V. | A grouped application consisting of: C.I.13: Submission of the final report from study MRX- 503 listed as category 3 study in the RMP. This is a phase 3 study to Evaluate the Long-Term Safety and Efficacy of Maralixibat in the Treatment of Subjects with Progressive Familial Intrahepatic Cholestasis (PFIC). The RMP version 7.2 has also been submitted. C.I.13: Submission of the final report for a retrospective study titled ''Analysis of Clinical Outcomes in PFIC: Comparison of Maralixibat from Studies MRX-502/503 and MRX-801 versus Natural History (NAtural course and Prognosis of PFIC and Effect of biliary Diversion [NAPPED])''. | | | No | Janet Koenig | | Adam Przybylkowski |
| EMA/VR/0000296462 | Variation type II | Qalsody | Tofersen | Biogen Netherlands B.V. | Update of sections 4.8, 5.1, and 5.2 of the SmPC to numerically update the summary of safety profile and description of selected adverse reactions, as well as, to update clinical efficacy and pharmacokinetic information based on final integrated analysis from Study 233AS101 and Study 233AS102. Submission of the final results of Study 233AS102 is listed as a specific obligation in the Annex II and a category 2 study in the RMP. Study 233AAS102 was an open label extension study to assess the long-term safety, tolerability, pharmacokinetics, and effect on disease progression of tofersen administered to previously treated adults with amyotrophic lateral sclerosis caused by superoxide dismutase 1 mutation. The RMP version 1.1 has also been submitted. In addition, the MAH took the opportunity to update the Annex II. | | | No | Janet Koenig | | Kimmo Jaakkola |
| EMA/VR/0000308060 | Variation type II | FOSAVANCE Adrovance VANTAVO | Alendronic acid / Colecalciferol Alendronic acid / Colecalciferol Alendronic acid / Colecalciferol | Organon N.V. | | | Quality | Yes | Christian Gartner | | |
| EMA/VR/0000319172 | Variation type II | Yervoy OPDIVO | Ipilimumab Nivolumab | Bristol-Myers Squibb Pharma EEIG | Update of sections 4.4 and 4.8 of the SmPC in order to add 'Myocarditis-Myositis-Myasthenia Gravis Overlap Syndrome' to the list of adverse drug reactions (ADRs) with frequency 'Uncommon' based on postmarketing data and literature. The Package Leaflet is updated accordingly. The RMP version 46 and 52 respectively, had also been submitted. In addition, the MAH took the opportunity to implement editorial changes to the PI. | | | Yes | Peter Mol | | Bianca Mulder |
| EMA/VR/0000317879 | Variation type II | Ryjunea | Atropine sulfate | Santen Oy | | | Quality | No | Alexandre Moreau | | |
| EMA/VR/0000322591 | Variation type II | Aucatzyl | Obecabtagene autoleucel | Autolus GmbH | | ATMP | Quality | No | Berendina Maria van den Hoorn | | |
| EMA/VR/0000319903 | Variation type II | BUCCOLAM | Midazolam | Neuraxpharm Pharmaceuticals S.L. | | | Quality | No | Peter Mol | | |
| EMA/VR/0000320140 | Variation type II | Hepcludex | Bulevirtide | Gilead Sciences Ireland Unlimited Company | A grouped application consisting of: C.I.4: Update of section 4.8 of the SmPC in order to remove a statement regarding bile acid elevations based on results from study MYR301, listed as a Category 3 study in the RMP. This is a Multicenter, Open-label, Randomized Phase 3 Clinical Study to Assess Efficacy and Safety of Bulevirtide in Patients With Chronic Hepatitis Delta to address the safety concern of 'Long-term safety of bile acid elevations' (Missing information). The RMP version 8.0 has also been submitted. C.I.11.b: Submission of an updated RMP version 8.0 in order to propose the removal of Study GS-US-589-6206 as a Category 3 Pharmacovigilance Commitment from the RMP for safety concern of 'Long-term safety of bile acid elevations' (Missing information). | | | No | Filip Josephson | | Adam Przybylkowski |
| EMA/VR/0000320727 | Variation type II | Truqap | Capivasertib | AstraZeneca AB | Update of sections 4.2, 4.4, 4.8, and 5.1 of the SmPC in order to change posology recommendations in Table 3, amend an existing warning for Hyperglycaemia, update the summary of safety profile & description of selected adverse reaction, update efficacy based on final results from study CAPItello-291 listed as a PAM Recommendation PAES; this is a phase 3 double-blind randomised study assessing the efficacy and safety of capivasertib + fulvestrant versus placebo + fulvestrant as treatment for locally advanced (inoperable) or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2−) breast cancer following recurrence or progression on or after treatment with an aromatase inhibitor. | | | No | Martin Mengel | | |
| EMA/VR/0000320745 | Variation type II | TECFIDERA | Dimethyl fumarate | Biogen Netherlands B.V. | Submission of the final study results from 109MS306 (CONNECT) Part 2 listed as a category 3 study in the RMP; this is a phase 3 efficacy and safety study of BG00012 in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term multiple sclerosis outcomes of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The RMP version 17.1 has also been submitted. | | | No | Janet Koenig | | Dennis Lex |
| EMA/VR/0000319893 | Variation type II | Jinarc | Tolvaptan | Otsuka Pharmaceutical Netherlands B.V. | Submission of the final report from study I156-00-003 (Study Drug Use-Results Survey of Samsca in ADPKD in Japan) and fulfilling MEA001 post approval commitment agreed by the CHMP and applicant at the time of authorization. This is a non-interventional study to confirm safety and efficacy in clinical practice, in cases where Samsca was used with the objective of “suppressing the progression of autosomal dominant polycystic kidney disease (ADPKD) in which kidney volume had already enlarged and which had a high rate of increase in kidney volume”. | | | No | Paolo Gasparini | | |
| EMA/VR/0000321323 | Variation type II | Qarziba | Dinutuximab beta | Recordati Netherlands B.V. | | | Quality | No | Peter Mol | | |
| EMA/VR/0000320535 | Variation type II | XGEVA | Denosumab | Amgen Europe B.V. | Update of section 4.8 of the SmPC in order to add ‘Injection site reactions’ to the list of adverse drug reactions (ADRs) with frequency uncommon, based on a cumulative safety review. The Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to update excipient information regarding polysorbates and to update the list of local representatives in the Package Leaflet. | | | No | Kristina Dunder | | |
| EMA/VR/0000321355 | Variation type II | Efmody | Hydrocortisone | Immedica Netherlands B.V. | | | Quality | No | Patrick Vrijlandt | | |
| EMA/VR/0000314828 | Variation type II | Tysabri | Natalizumab | Biogen Netherlands B.V. | | | Quality | No | Jan Mueller-Berghaus | | |
| EMA/VR/0000320244 | Variation type II | mRESVIA | Respiratory syncytial virus mRNA vaccine (nucleoside modified) | Moderna Biotech Spain S.L. | Update of sections 4.4, 4.8 and 5.1 of the SmPC in order to update clinical efficacy and safety information on the use of mRESVIA in immunocompromised individuals 18 years of age and older, based on interim results from study mRNA-1345-P303 Part B; this is a Phase 3 study to evaluate the immunogenicity and safety of mRNA-1345, an mRNA vaccine targeting respiratory syncytial virus, in high-risk adults. The updated RMP version 6.0 has also been submitted. | | | No | Jan Mueller-Berghaus | | Jean-Michel Dogné |
| EMA/VR/0000314736 | Variation type II | Zilbrysq | Zilucoplan | UCB Pharma | | | Quality | No | Kristina Dunder | | |
| EMA/VR/0000319620 | Variation type II | Loargys | Pegzilarginase | Immedica Pharma AB | Update of sections 4.2, 4.8, 5.1 and 5.2 of the SmPC in order to update information regarding children below 2 years of age based on final results from study CAEB1102-301A listed as Study 6 in the Loargys PIP (EMEA-001925-PIP02-19-M0). Study 301A is a phase 3 open-label study of safety, pharmacokinetics, and activity of weekly subcutaneous pegzilarginase in subjects <24 months old with arginase 1 deficiency. In addition, the MAH took the opportunity to introduce editorial changes to the PI. | | | No | Peter Mol | | |
| EMA/VR/0000317924 | Variation type II | Mayzent | Siponimod | Novartis Europharm Limited | A grouped application consisting of: Type II (C.I.13): Submission of the final report from study CBAF312A2006 listed as a category 3 study in the RMP. This is a survey conducted among healthcare professionals and Multiple Sclerosis patients/caregivers in selected European countries plus Canada to evaluate the knowledge required for the safe use of Mayzent (siponimod). The RMP version 8.0 has also been submitted. Type IB (C.I.11): Submission of an updated RMP version 8.0 in order to update the siponimod exposure data in accordance with the results of the drug-drug interaction study CBAF312A02101 in alignment with the EMA/VR/0000255116 procedure. | | | No | | | Maria del Pilar Rayon |
| EMA/VR/0000321342 | Variation type II | Cufence | Trientine | Univar Solutions B.V. | | | Quality | No | Daniela Philadelphy | | |
| EMA/VR/0000301757 | Variation type II | Flebogamma DIF | Human normal immunoglobulin | Instituto Grifols S.A. | | | Quality | Yes | Jan Mueller-Berghaus | | |
| EMA/VR/0000301874 | Variation type II | Vaxelis | diphtheria, tetanus, pertussis acellular component, hepatitis B rDNA, poliomyelitis inactivated and haemophilus type b conjugate vaccine adsorbed | MCM Vaccine B.V. | | | Quality | No | Christophe Focke | | |
| EMA/VR/0000317483 | Variation type II | Beromun | Tasonermin | Belpharma S.A. | | | Quality | No | Thalia Marie Estrup Blicher | | |
| EMA/VR/0000303437 | Variation type II | Trixeo Aerosphere Riltrava Aerosphere | Formoterol / Glycopyrronium bromide / Budesonide Formoterol / Glycopyrronium bromide / Budesonide | AstraZeneca AB | | | Quality | Yes | Finbarr Leacy | | |
| EMA/VR/0000321287 | Variation type II | PHELINUN | Melphalan | Adienne S.r.l. | | | Quality | No | Peter Mol | | |
| EMA/VR/0000303441 | Variation type II | Urorec Silodyx Silodosin Recordati | Silodosin Silodosin Silodosin | Recordati Ireland Limited | | | Quality | Yes | Paolo Gasparini | | |
| EMA/VR/0000320187 | Variation type II | Suliqua | Insulin glargine / Lixisenatide | Sanofi Winthrop Industrie | Update of sections 4.2, 4.8, and 5.1 of the SmPC in order to introduce a new posology regimen based on final results from study LPS17008 (SoliSwitch); this is a 24-week, single-arm, phase 4 clinical study to evaluate the efficacy and safety of switching to iGlarLixi in people with type 2 diabetes mellitus uncontrolled on once or twice daily premixed insulin regimen. In addition, the MAH took the opportunity change to update "diabetes mellitus" to "diabetes" throughout the SmPC to reflect latest medical understanding. | | | No | Kristina Dunder | | |
| EMA/VR/0000315310 | Variation type II | Pandemic influenza vaccine H5N1 AstraZeneca Fluenz | pandemic influenza vaccine (H5N1) (live attenuated, nasal) Influenza vaccine (live, nasal) | AstraZeneca AB | | | Quality | Yes | Christophe Focke | | |
| EMA/VR/0000297114 | Variation type II | Vyndaqel | Tafamidis | Pfizer Europe MA EEIG | Update of sections 4.4 and 4.5 of the SmPC in order to add a new warning on co-administration tafamidis meglumine/tafamidis and BCRP substrates, update drug-drug interaction information with BCRP sustrates following the PRAC PSUR assessment report for procedure no.: EMEA/H/C/PSUSA/00002842/202405. The Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to update the European Medicines Agency website address in line with the latest EU CP QRD template version 10.4. | | | No | | | Zoubida Amimour |
| EMA/VR/0000319048 | Variation type II | Erleada | Apalutamide | Janssen Cilag International | Update of section 4.5 of the SmPC in order to include information regarding apalutamide interference with a digoxin laboratory test based on a cumulative safety review, following the PRAC request in procedure PSUSA/00010745/202502. In addition, the MAH took the opportunity to introduce minor editorial changes and to update the list of local representatives in the Package Leaflet. | | | No | | | Tiphaine Vaillant |
| EMA/VR/0000320259 | Variation type II | Saphnelo | Anifrolumab | AstraZeneca AB | Update of sections 4.4, 4.8, and 5.1 of the SmPC in order to add new safety and efficacy data, based on final results from the TULIP SC study (D3465C00001); this is a Phase III, randomized, double-blind, multicenter, parallel-group, placebo-controlled study to evaluate the efficacy, safety, and tolerability of anifrolumab 120 mg, administrated weekly via subcutaneous route, added to standard of care in adults with moderate to severe Systemic Lupus Erythematosus; the Package Leaflet is updated accordingly. | | | No | Outi Mäki-Ikola | | |
| EMA/VR/0000316471 | Variation type II | Xeloda | Capecitabine | Cheplapharm Arzneimittel GmbH | | | Quality | No | Martin Mengel | | |
| EMA/VR/0000321500 | Variation type II | Orserdu | Elacestrant | Stemline Therapeutics B.V. | Update of sections 4.2, 4.4, and 5.2 of the SmPC in order to add a dose recommendation for patients with severe hepatic impairment and update pharmacokinetic information based on the results from study STML-ELA-1023 and PBPK modelling. STML-ELA-1023 is a phase 1, open-label, non-randomized, parallel-group study to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of 200 mg elacestrant in subjects with normal hepatic function or severe hepatic impairment. The MAH is also taking this opportunity to introduce minor editorial corrections in SmPC section 5.2. | | | No | Peter Mol | | |
| EMA/VR/0000267599 | Variation type II | Adenuric | Febuxostat | Menarini International Operations Luxembourg S.A. | | | Quality | No | Christian Gartner | | |
| EMA/VR/0000320718 | Variation type II | Trumenba | Meningococcal group B vaccine (recombinant, adsorbed) | Pfizer Europe MA EEIG | | | Quality | No | Patrick Vrijlandt | | |
| EMA/VR/0000302769 | Variation type II | LEQEMBI | Lecanemab | Eisai GmbH | Submission of an updated RMP version 1.1 in order to propose an update to PASS study deadlines. In addition, the MAH has taken the opportunity to update Annex II accordingly. | | | No | | | Eva Jirsová |
| EMA/VR/0000323136 | Variation type II | Taltz | Ixekizumab | Eli Lilly and Co (Ireland) Limited | Update of sections 4.8 and 5.1 of the SmPC in order to update clinical information, following the outcome of the Article 46 procedure EMA/PAM/0000293431, based on the final study data for ixekizumab paediatric psoriasis study I1F-MC-RHCD (IXORA-PEDS). In addition, the MAH took the opportunity to update excipient information in the Labelling section according to the excipient guideline. | | | No | Kristina Dunder | | |
| EMA/VR/0000312996 | Variation type II | BIMERVAX | COVID-19 vaccine (recombinant, adjuvanted) | Hipra Human Health S.L. | | | Quality | No | Beata Maria Jakline Ullrich | | |
| EMA/VR/0000302084 | Variation type II | Ixiaro | japanese encephalitis vaccine (inactivated, adsorbed) | Valneva Austria GmbH | | | Quality | No | Jan Mueller-Berghaus | | |
| EMA/VR/0000323076 | Variation type II | Fulphila | Pegfilgrastim | Biosimilar Collaborations Ireland Limited | | | Quality | No | Martin Mengel | | |
| EMA/VR/0000319452 | Variation type II | Puregon | Follitropin beta | Organon N.V. | | | Quality | No | Ruth Kieran | | |
| EMA/VR/0000322800 | Variation type II | Palynziq | Pegvaliase | Biomarin International Limited | Update of sections 4.2 Method of administration, 4.4 Special warnings and precautions for use, and 4.8 Undesirable effects of the SmPC with a new warning regarding injection site infection based on data from clinical trials and post-marketing data sources; the Package Leaflet is updated accordingly. | | | No | Patrick Vrijlandt | | |
| EMA/VR/0000314841 | Variation type II | Kisunla | Donanemab | Eli Lilly Nederland B.V. | | | Quality | No | Peter Mol | | |
| EMA/VR/0000308184 | Variation type II | Urorec Silodyx Silodosin Recordati | Silodosin Silodosin Silodosin | Recordati Ireland Limited | | | Quality | Yes | Paolo Gasparini | | |
| EMA/VR/0000321361 | Variation type II | NUBEQA | Darolutamide | Bayer AG | | | Quality | No | Alexandre Moreau | | |
| EMA/VR/0000317322 | Variation type II | Keytruda | Pembrolizumab | Merck Sharp & Dohme B.V. | Update of section 4.4 of the SmPC in order to add a new warning on myocarditis-myositis-myasthenia gravis overlap based on pembrolizumab clinical trial data and global safety data; the Package Leaflet is updated accordingly. | | | No | Paolo Gasparini | | |
| EMA/VR/0000320240 | Variation type II | Neoatricon | Dopamine hydrochloride | BrePco Biopharma Limited | | | Quality | No | Janet Koenig | | |
| EMA/VR/0000321439 | Variation type II | LEQEMBI | Lecanemab | Eisai GmbH | Update of section 5.1 of the SmPC in order to update immunogenicity information based on Study 301 Core data re-analyzed using an optimized ADA assay. | | | No | Alexandre Moreau | | |
| EMA/VR/0000316588 | Variation type II | Iclusig | Ponatinib | Incyte Biosciences Distribution B.V. | | | Quality | No | Filip Josephson | | |
| EMA/VR/0000317918 | Variation type II | SARCLISA | Isatuximab | Sanofi Winthrop Industrie | | | Quality | No | Peter Mol | | |
| EMA/VR/0000320262 | Variation type II | Ferriprox | Deferiprone | Chiesi Farmaceutici S.p.A. | | | Quality | No | Alexandre Moreau | | |
| EMA/VR/0000308587 | Variation type II | Forxiga Xigduo Qtern Edistride Ebymect | Dapagliflozin Dapagliflozin / Metformin Saxagliptin / Dapagliflozin Dapagliflozin Dapagliflozin / Metformin | AstraZeneca AB | Submission of the final report from the Cancer PASS study D1690R00007 listed as a category 3 study in the RMP. This is a post-authorisation observational study, final (120-month) report: comparison of the risk of cancer between patients with type 2 diabetes exposed to dapagliflozin and those exposed to other antidiabetic treatments. The RMP versions 32.0 for Forxiga & Edistride, 16.0 for Xigduo & Ebymect and 11.0 for Qtern have also been submitted. | | | Yes | | | Mari Thorn |
| EMA/VR/0000315465 | Variation type II | Kisqali | Ribociclib | Novartis Europharm Limited | Update of section 5.3 of the SmPC in order to non-clinical information based on the final results from study the juvenile toxicity studies 2070096 and 2070095. Study 2070096 is listed as study 2 of the PIP EMEA-002765-PIP02-21-M01 in neuroblastoma for Kisqali. | | | No | Filip Josephson | | |
| EMA/VR/0000332852 | Variation type II | Flucelvax | influenza vaccine (surface antigen, inactivated, prepared in cell cultures) | Seqirus Netherlands B.V. | Update of section 4.8 of the SmPC in order to add ‘febrile convulsion’ to the list of adverse drug reactions (ADRs) with frequency not known, based on a safety review. The Package Leaflet is updated accordingly. | | | No | Sol Ruiz | | |