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Human medicines European public assessment report (EPAR): Zabdeno, ebola vaccine (Ad26.ZEBOV-GP [recombinant]), Date of authorisation: 01/07/2020, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 7, 2025 0

Human medicines European public assessment report (EPAR): Zabdeno, ebola vaccine...

Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2025, European Medicines Agency, Amsterdam, the Netherlands, from 7 April 2025 to 10 April 2025

Pharmacovigilance Risk Assessment Committee (PRAC): 7-1...

Apr 7, 2025 0

Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2025, European Me...

New product information wording: extracts from PRAC rec...

Apr 7, 2025 0

New product information wording: extracts from PRAC recommendations on signals a...

Human medicines European public assessment report (EPAR): Avtozma, tocilizumab, Date of authorisation: 14/02/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 7, 2025 0

Human medicines European public assessment report (EPAR): Avtozma, tocilizumab, ...

PRAC recommendations on signals adopted at the 10-13 Ma...

Apr 7, 2025 0

PRAC recommendations on signals adopted at the 10-13 March 2025 meeting

Medicine shortage communications (MSC)

Medicine shortage communications (MSC)

Apr 7, 2025 0

Medicine shortage communications (MSC)

Medicine shortage communication (MSC): Mimpara (cinacal...

Apr 7, 2025 0

Medicine shortage communication (MSC): Mimpara (cinacalcet)

Mimpara

Apr 7, 2025 0

Mimpara

Human medicines European public assessment report (EPAR): Azacitidine Mylan, azacitidine, Date of authorisation: 27/03/2020, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 7, 2025 0

Human medicines European public assessment report (EPAR): Azacitidine Mylan, aza...

Human medicines European public assessment report (EPAR): Elrexfio, elranatamab, Date of authorisation: 07/12/2023, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 7, 2025 0

Human medicines European public assessment report (EPAR): Elrexfio, elranatamab,...

Human medicines European public assessment report (EPAR): Tivdak, tisotumab vedotin, Date of authorisation: 28/03/2025, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 7, 2025 0

Human medicines European public assessment report (EPAR): Tivdak, tisotumab vedo...

Orphan designation: single guide RNA containing a sequence complementary to human ALB locus gene, intron 1, target region, Ziclumeran Treatment of haemophilia B, 25/03/2025 Positive

Orphan designation: single guide RNA containing a seque...

Apr 7, 2025 0

Orphan designation: single guide RNA containing a sequence complementary to huma...

Orphan designation: povetacicept Treatment of primary IgA nephropathy, 25/03/2025 Positive

Orphan designation: povetacicept Treatment of primary I...

Apr 7, 2025 0

Orphan designation: povetacicept Treatment of primary IgA nephropathy, 25/03/202...

Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on personalised medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 8 April 2025, 10:00 (CEST) to 9 April 2025, 15:30 (CEST)

Quality Innovation Group (QIG) Listen and Learn Focus G...

Apr 7, 2025 0

Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on pe...

Orphan designation: extract from Cannabis flower, containing high levels of cannabidiolic acid and <0.3% of tetrahydrocannabinol, Extraction solvent: olive oil, virgin Treatment of Rett syndrome, 25/03/2025 Positive

Orphan designation: extract from Cannabis flower, conta...

Apr 7, 2025 0

Orphan designation: extract from Cannabis flower, containing high levels of cann...

Orphan designation: allopurinol Treatment of Marfan syndrome, 25/03/2025 Positive

Orphan designation: allopurinol Treatment of Marfan syn...

Apr 7, 2025 0

Orphan designation: allopurinol Treatment of Marfan syndrome, 25/03/2025 Positive

Orphan designation: adeno-associated virus vector serotype 8 containing the human F9 gene Treatment of haemophilia B, 25/03/2025 Positive

Orphan designation: adeno-associated virus vector serot...

Apr 7, 2025 0

Orphan designation: adeno-associated virus vector serotype 8 containing the huma...

Thirteenth meeting of the industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, 2 December 2024

Thirteenth meeting of the industry stakeholder platform...

Apr 4, 2025 0

Thirteenth meeting of the industry stakeholder platform on research and developm...

Highlight report - 13th Industry stakeholder platform o...

Apr 4, 2025 0

Highlight report - 13th Industry stakeholder platform on research and developmen...

SMS guidance for external users

Apr 4, 2025 0

SMS guidance for external users

PSUSA/00002942/202406

PSUSA/00002942/202406

Apr 4, 2025 0

PSUSA/00002942/202406

Human medicines European public assessment report (EPAR): Roclanda, latanoprost / netarsudil, Date of authorisation: 07/01/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 4, 2025 0

Human medicines European public assessment report (EPAR): Roclanda, latanoprost ...

Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Date of authorisation: 28/03/2019, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 4, 2025 0

Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, D...

Human medicines European public assessment report (EPAR): Opsumit, macitentan, Date of authorisation: 20/12/2013, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 4, 2025 0

Human medicines European public assessment report (EPAR): Opsumit, macitentan, D...

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