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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, ...

Human medicines European public assessment report (EPAR): GeGant, Germanium (68Ge) chloride,Gallium (68Ga) chloride, Status: Application withdrawn

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): GeGant, Germanium (68G...

Human medicines European public assessment report (EPAR): ProQuad, measles, mumps, rubella and varicella vaccine (live), Date of authorisation: 05/04/2006, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): ProQuad, measles, mump...

Human medicines European public assessment report (EPAR): Aripiprazole Accord, aripiprazole, Date of authorisation: 15/11/2015, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Aripiprazole Accord, a...

Human medicines European public assessment report (EPAR): Sunlenca, lenacapavir, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Sunlenca, lenacapavir,...

Human medicines European public assessment report (EPAR): Sitagliptin SUN, sitagliptin fumarate, Date of authorisation: 09/12/2021, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Sitagliptin SUN, sitag...

Human medicines European public assessment report (EPAR): MenQuadfi, meningococcal group A, C, W-135 and Y conjugate vaccine, Date of authorisation: 18/11/2020, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): MenQuadfi, meningococc...

ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline

ICH Guideline M13A on bioequivalence for immediate-rele...

Feb 26, 2025 0

ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage for...

Investigation of bioequivalence - Scientific guideline

Investigation of bioequivalence - Scientific guideline

Feb 26, 2025 0

Investigation of bioequivalence - Scientific guideline

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vaccine (recombinant, adjuvanted),selvacovatein,damlecovatein, Date of authorisation: 30/03/2023, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Bimervax, COVID-19 Vac...

Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide,formoterol, Date of authorisation: 19/11/2014, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 26, 2025 0

Human medicines European public assessment report (EPAR): Duaklir Genuair, aclid...

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