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Human medicines European public assessment report (EPAR): Spinraza, nusinersen, Date of authorisation: 30/05/2017, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Spinraza, nusinersen, ...

Human medicines European public assessment report (EPAR): Xalkori, crizotinib, Date of authorisation: 23/10/2012, Revision: 37, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Xalkori, crizotinib, D...

Addendum to the Guideline on clinical development of va...

Feb 27, 2025 0

Addendum to the Guideline on clinical development of vaccines to address clinica...

Clinical Trial Information System (CTIS) evaluation tim...

Feb 27, 2025 0

Clinical Trial Information System (CTIS) evaluation timelines

Clinical evaluation of new vaccines - Scientific guideline

Clinical evaluation of new vaccines - Scientific guideline

Feb 27, 2025 0

Clinical evaluation of new vaccines - Scientific guideline

Human medicines European public assessment report (EPAR): Voydeya, Danicopan, Date of authorisation: 19/04/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Voydeya, Danicopan, Da...

Human medicines European public assessment report (EPAR): Evkeeza, evinacumab, Date of authorisation: 17/06/2021, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Evkeeza, evinacumab, D...

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 18 February 2025, 09:30 (CET) to 18 February 2025, 13:00 (CET)

Meeting of the Medicine Shortages Single Point of Conta...

Feb 27, 2025 0

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, ...

Human medicines European public assessment report (EPAR): Biktarvy, bictegravir,emtricitabine,tenofovir alafenamide, Date of authorisation: 21/06/2018, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Biktarvy, bictegravir,...

Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Date of authorisation: 08/01/2018, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Fasenra, benralizumab,...

Human medicines European public assessment report (EPAR): Somavert, pegvisomant, Date of authorisation: 12/11/2002, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Somavert, pegvisomant,...

Herbal medicinal product: Pilosellae herba cum radice, Hieracium pilosella L., F: Assessment finalised

Herbal medicinal product: Pilosellae herba cum radice, ...

Feb 27, 2025 0

Herbal medicinal product: Pilosellae herba cum radice, Hieracium pilosella L., F...

Herbal medicinal product: Tribuli terrestris herba, Tribulus terrestris L., D: Draft under discussion

Herbal medicinal product: Tribuli terrestris herba, Tri...

Feb 27, 2025 0

Herbal medicinal product: Tribuli terrestris herba, Tribulus terrestris L., D: D...

Herbal medicinal product: Prunus avium peduncle, Prunus avium L.,Prunus cerasus L., D: Draft under discussion

Herbal medicinal product: Prunus avium peduncle, Prunus...

Feb 27, 2025 0

Herbal medicinal product: Prunus avium peduncle, Prunus avium L.,Prunus cerasus ...

Human medicines European public assessment report (EPAR): Wezenla, ustekinumab, Date of authorisation: 20/06/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Wezenla, ustekinumab, ...

Human medicines European public assessment report (EPAR): Steqeyma, ustekinumab, Date of authorisation: 22/08/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Steqeyma, ustekinumab,...

Annex - National provisions for SMEs applicable to the ...

Feb 26, 2025 0

Annex - National provisions for SMEs applicable to the pharmaceutical sector

Certificates Processing System: Demo & Q&A session for industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 March 2025, 12:30 (CET) to 13 March 2025, 13:00 (CET)

Certificates Processing System: Demo & Q&A session for ...

Feb 26, 2025 0

Certificates Processing System: Demo & Q&A session for industry stakeholders, On...

Human medicines European public assessment report (EPAR): Kostaive, zapomeran, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Kostaive, zapomeran, S...

Human medicines European public assessment report (EPAR): Micardis, telmisartan, Date of authorisation: 16/12/1998, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Micardis, telmisartan,...

Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 24 September 2024, 09:00 (CEST) to 24 September 2024, 17:00 (CEST)

Joint EC/HMA/EMA multi-stakeholder workshop on pharmaco...

Feb 26, 2025 0

Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics, Online, Europea...

Human medicines European public assessment report (EPAR): Fampridine Accord, fampridine, Date of authorisation: 24/09/2020, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Fampridine Accord, fam...

Human medicines European public assessment report (EPAR): MicardisPlus, Date of authorisation: 19/04/2002, Revision: 36, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): MicardisPlus, Date of ...

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, ...

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