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Last updated about 9 hours ago
Orphan designation: adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene Treatment of Duchenne muscular dystrophy, 29/08/2016 Withdrawn
about 9 hours ago
Orphan designation: adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene...
Orphan designation: RNA editing antisense oligonucleotide against the Z mutation of the human SERPINA1 mRNA transcript, sodium salt Treatment of alpha-1 antitrypsin deficiency, 22/08/2025 Withdrawn
about 9 hours ago
Orphan designation: RNA editing antisense oligonucleotide against the Z mutation of the...
Human medicines European public assessment report (EPAR): Zoledronic acid medac, zoledronic acid, Date of authorisation: 03/08/2012, Revision: 14, Status: Authorised
about 10 hours ago
Human medicines European public assessment report (EPAR): Zoledronic acid medac, zoledronic acid...
Human medicines European public assessment report (EPAR): Ixchiq, Chikungunya vaccine (live), Date of authorisation: 28/06/2024, Revision: 4, Status: Authorised
about 11 hours ago
Human medicines European public assessment report (EPAR): Ixchiq, Chikungunya vaccine (live), Date...
Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (27 February 2026 - 26 March 2026)
about 11 hours ago
Start of procedure: Type II Variation - Extension of indication under evaluation...
Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (30 January 2026 - 26 February 2026)
about 11 hours ago
Start of procedure: Type II Variation - Extension of indication under evaluation...
Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir,ritonavir, Date of authorisation: 28/01/2022, Revision: 30, Status: Authorised
about 11 hours ago
Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir,ritonavir, Date of authorisation...
Questions and answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies
about 11 hours ago
Questions and answers - Practical arrangements on the companion diagnostics consultation procedure...
Questions and answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies - tracked changes
about 11 hours ago
Questions and answers - Practical arrangements on the companion diagnostics consultation procedure...
Human medicines European public assessment report (EPAR): Besponsa, inotuzumab ozogamicin, Date of authorisation: 28/06/2017, Revision: 12, Status: Authorised
about 11 hours ago
Human medicines European public assessment report (EPAR): Besponsa, inotuzumab ozogamicin, Date of...
Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Date of authorisation: 27/07/2020, Revision: 15, Status: Authorised
about 12 hours ago
Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Date of authorisation...