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Chapter 5: eXtended EudraVigilance Product Report Acknowledgement Message - Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA

Chapter 3.II: XEVPRM detailed user guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA

Committee for Advanced Therapies (CAT): 6-8 November 2024, European Medicines Agency, Amsterdam, the Netherlands, from 6 November 2024 to 8 November 2024

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Human medicines European public assessment report (EPAR): Epixram, levetiracetam, Status: Application withdrawn

Human medicines European public assessment report (EPAR): GONAL-f, follitropin alfa, Date of authorisation: 20/10/1995, Revision: 27, Status: Authorised

Second European Medicines Agency (EMA) and IPFA - PPTA global bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 12 November 2024

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group