Biopharma

Human medicines European public assessment report (EPAR): Jaypirca, pirtobrutinib, Date of authorisation: 30/10/2023, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Jaypirca, pirtobrutini...

Human medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Tevimbra, tislelizumab...

Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis), vildagliptin,metformin, Date of authorisation: 30/11/2008, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Icandra (previously Vi...

Questions and answers on implementation of the medical ...

Feb 9, 2025 0

Questions and answers on implementation of the medical devices and in vitro diag...

PSUSA/00002229/202404

PSUSA/00002229/202404

Feb 9, 2025 0

PSUSA/00002229/202404

Veterinary medicines European public assessment report (EPAR): Tolfenamic acid VMD, Tolfenamic acid, Status: Authorised

Veterinary medicines European public assessment report ...

Feb 9, 2025 0

Veterinary medicines European public assessment report (EPAR): Tolfenamic acid V...

Human medicines European public assessment report (EPAR): Keytruda, pembrolizumab, Date of authorisation: 17/07/2015, Revision: 63, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Keytruda, pembrolizuma...

P/87/2010

Feb 9, 2025 0

P/87/2010

Human medicines European public assessment report (EPAR): Eurneffy, epinephrine, Date of authorisation: 22/08/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Eurneffy, epinephrine,...

Submission deadlines for orphan designations

Submission deadlines for orphan designations

Feb 9, 2025 0

Submission deadlines for orphan designations

Human medicines European public assessment report (EPAR): Mounjaro, tirzepatide, Date of authorisation: 15/09/2022, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Mounjaro, tirzepatide,...

Human medicines European public assessment report (EPAR): Epruvy (previously Ranibizumab Midas), ranibizumab, Date of authorisation: 19/09/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Epruvy (previously Ran...

EudraVigilance training and support

EudraVigilance training and support

Feb 9, 2025 0

EudraVigilance training and support

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - December 2024, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 December 2024, 09:00 (CET) to 11 December 2024, 10:30 (CET)

Meeting of the Executive Steering Group on Shortages an...

Feb 9, 2025 0

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Pro...

Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Scientific guideline

Guideline on quality, non-clinical and clinical require...

Feb 9, 2025 0

Guideline on quality, non-clinical and clinical requirements for investigational...

Training on human variations web-based electronic application form (eAF) functionalities for non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 February 2025, 10:30 (CET) to 11 February 2025, 12:30 (CET)

Training on human variations web-based electronic appli...

Feb 9, 2025 0

Training on human variations web-based electronic application form (eAF) functio...

EMA human resources strategy: Priorities 2023-2025

Feb 9, 2025 0

EMA human resources strategy: Priorities 2023-2025

Careers

Feb 9, 2025 0

Careers

Product Management Service (PMS) webinar on Product User Interface (PUI) edit functionalities for industry users, Online, from 28 January 2025, 10:00 (CET) to 28 January 2025, 12:00 (CET)

Product Management Service (PMS) webinar on Product Use...

Feb 9, 2025 0

Product Management Service (PMS) webinar on Product User Interface (PUI) edit fu...

PRIME: priority medicines

PRIME: priority medicines

Feb 9, 2025 0

PRIME: priority medicines

Recommendations on eligibility to PRIME scheme - Adopte...

Feb 9, 2025 0

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of ...

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 4 February 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 4 February 2025, 11:00 (CET) to 4 February 2025, 11:45 (CET)

Questions and answers clinic on Product Management Serv...

Feb 9, 2025 0

Questions and answers clinic on Product Management Service (PMS) Product User In...

List of medicines currently in PRIME scheme

Feb 9, 2025 0

List of medicines currently in PRIME scheme

Human medicines European public assessment report (EPAR): Kesimpta, ofatumumab, Date of authorisation: 26/03/2021, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 9, 2025 0

Human medicines European public assessment report (EPAR): Kesimpta, ofatumumab, ...

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