PRAC Recommendations on Safety Signals

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. 27 October 2025 Pharmacovigilance Risk Assessment Committee (PRAC) Adopted at the 29 September-2 October 2025 PRAC meeting This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 29 September-2 October 2025 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] reference numbers). PRAC recommendations to provide supplementary information are directly actionable by the concerned marketing authorisation holders (MAHs). PRAC recommendations for regulatory action (e.g. amendment of the product information) are submitted to the Committee for Medicinal Products for Human Use (CHMP) for endorsement when the signal concerns Centrally Authorised Products (CAPs), and to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for information in the case of Nationally Authorised Products (NAPs). Thereafter, MAHs are expected to take action according to the PRAC recommendations. When appropriate, the PRAC may also recommend the conduct of additional analyses by the Agency or Member States. MAHs are reminded that in line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of Directive 2001/83/EC, they shall ensure that their product information is kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations published on the European Medicines Agency (EMA) website (currently acting as the EU medicines webportal). For CAPs, at the time of publication, PRAC recommendations for update of product information have been agreed by the CHMP at their plenary meeting (13-16 October 2025) and corresponding variations will be assessed by the CHMP. For nationally authorised medicinal products, it is the responsibility of the National Competent Authorities (NCAs) of the Member States to oversee that PRAC recommendations on signals are adhered to. Expected publication date. The actual publication date can be checked on the webpage dedicated to PRAC recommendations on safety signals. The relevant EPITT reference number should be used in any communication related to a signal.

Page 2/3 Variations for CAPs are handled according to established EMA procedures. MAHs are referred to the available guidance. Variations for NAPs (including via mutual recognition and decentralised procedures) are handled at national level in accordance with the provisions of the Member States. The timeline recommended by PRAC for submission of variations following signal assessment is applicable to both innovator and generic medicinal products, unless otherwise specified. For procedural aspects related to the handling of PRAC recommendations on signals (e.g. submission requirements, contact points, etc.) please refer to the Questions and Answers on signal management.

Page 3/3 1. Recommendations for update of the product information Not applicable 2. Recommendations for submission of supplementary information INN Signal (EPITT No) PRAC Rapporteur Action for MAH MAH Pancreatin Infection due to viral transmission (20205) Martin Huber (DE) Supplementary information requested (submission by 10 December 2025) Viatris, Mylan, Berlin-Chemie, Gedeon Richter Plc., Laboratoires Mayoly Spindler, SC Biofarm SA, Krka d.d. Novo Mesto, Avva Pharmaceuticals Ltd, Pharmaselect International Beteiligung GmbH, Trommsdorff GmbH & Co Tirzepatide Drug interaction with warfarin and other coumarin derivatives leading to international normalised ratio decreased (20198) Bianca Mulder (NL) Supplementary information requested (submission by 7 January 2026) Eli Lilly Nederland B.V. 3. Other recommendations Not applicable