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EMEA-002945-PIP03-23

EMEA-002945-PIP03-23

Mar 25, 2025 0

EMEA-002945-PIP03-23

EMEA-002886-PIP02-23

EMEA-002886-PIP02-23

Mar 25, 2025 0

EMEA-002886-PIP02-23

Guidance on the application of the amended Variations Regulation from 1 January 2025

Guidance on the application of the amended Variations R...

Mar 25, 2025 0

Guidance on the application of the amended Variations Regulation from 1 January ...

Notifying a change of marketing status

Notifying a change of marketing status

Mar 25, 2025 0

Notifying a change of marketing status

European Medicines Agency procedural advice on recommen...

Mar 25, 2025 0

European Medicines Agency procedural advice on recommendations on unforeseen var...

Periodic safety update reports (PSURs)

Periodic safety update reports (PSURs)

Mar 25, 2025 0

Periodic safety update reports (PSURs)

Post-authorisation safety studies (PASS)

Post-authorisation safety studies (PASS)

Mar 25, 2025 0

Post-authorisation safety studies (PASS)

Human medicines European public assessment report (EPAR): Sugammadex Amomed, sugammadex, Date of authorisation: 10/01/2023, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 25, 2025 0

Human medicines European public assessment report (EPAR): Sugammadex Amomed, sug...

Human medicines European public assessment report (EPAR): Onpattro, patisiran, Date of authorisation: 27/08/2018, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 25, 2025 0

Human medicines European public assessment report (EPAR): Onpattro, patisiran, D...

Grouping of variations: questions and answers

Grouping of variations: questions and answers

Mar 25, 2025 0

Grouping of variations: questions and answers

Extensions of marketing authorisations: questions and answers

Extensions of marketing authorisations: questions and a...

Mar 25, 2025 0

Extensions of marketing authorisations: questions and answers

Human medicines European public assessment report (EPAR): Mvabea, Ebola vaccine (MVA-BN-Filo [recombinant]), Date of authorisation: 01/07/2020, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 25, 2025 0

Human medicines European public assessment report (EPAR): Mvabea, Ebola vaccine ...

Agenda - PDCO agenda of the 25-28 March 2025 meeting

Mar 25, 2025 0

Agenda - PDCO agenda of the 25-28 March 2025 meeting

Minutes of the CVMP meeting 11-12 February 2025

Mar 25, 2025 0

Minutes of the CVMP meeting 11-12 February 2025

EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 October 2025, 10:00 (CEST) to 9 October 2025, 16:10 (CEST)

EMA multi-stakeholder workshop on reporting and qualifi...

Mar 25, 2025 0

EMA multi-stakeholder workshop on reporting and qualification of mechanistic mod...

EMEA-002796-PIP01-20-M02

EMEA-002796-PIP01-20-M02

Mar 25, 2025 0

EMEA-002796-PIP01-20-M02

EMEA-002744-PIP01-19-M01

EMEA-002744-PIP01-19-M01

Mar 25, 2025 0

EMEA-002744-PIP01-19-M01

EMEA-002734-PIP01-19-M01

EMEA-002734-PIP01-19-M01

Mar 25, 2025 0

EMEA-002734-PIP01-19-M01

Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0038/2024

Opinion/decision on a Paediatric investigation plan (PI...

Mar 25, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemacicli...

Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemaciclib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0037/2024

Opinion/decision on a Paediatric investigation plan (PI...

Mar 24, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Verzenios, abemacicli...

Paediatric investigation plans: questions and answers

Paediatric investigation plans: questions and answers

Mar 24, 2025 0

Paediatric investigation plans: questions and answers

Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib, Date of authorisation: 22/03/2017, Date of refusal: 25/04/2013, Revision: 34, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 24, 2025 0

Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib, ...

Human medicines European public assessment report (EPAR): Seladelpar Gilead, Seladelpar lysine dihydrate, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 24, 2025 0

Human medicines European public assessment report (EPAR): Seladelpar Gilead, Sel...

Opinion/decision on a Paediatric investigation plan (PIP): Exparel liposomal, bupivacaine, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pain, PIP number: P/0021/2024

Opinion/decision on a Paediatric investigation plan (PI...

Mar 24, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Exparel liposomal, bu...

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