What's new

European Medicines Agency procedural advice for users o...

Feb 24, 2025 0

European Medicines Agency procedural advice for users of the centralised procedu...

European Medicines Agency procedural advice for users o...

Feb 24, 2025 0

European Medicines Agency procedural advice for users of the centralised procedu...

European Medicines Agency pre-authorisation procedural ...

Feb 24, 2025 0

European Medicines Agency pre-authorisation procedural advice for users of the c...

European Medicines Agency pre-authorisation procedural ...

Feb 24, 2025 0

European Medicines Agency pre-authorisation procedural advice for users of the c...

Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib, Date of authorisation: 22/03/2017, Date of refusal: 25/04/2013, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 24, 2025 0

Human medicines European public assessment report (EPAR): Xeljanz, tofacitinib, ...

Marketing authorisation application (MAA) - pre-submiss...

Feb 24, 2025 0

Marketing authorisation application (MAA) - pre-submission interactions form

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Date of authorisation: 26/05/2016, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 24, 2025 0

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,v...

Pre-authorisation guidance

Pre-authorisation guidance

Feb 24, 2025 0

Pre-authorisation guidance

Human medicines European public assessment report (EPAR): Entresto, sacubitril,valsartan, Date of authorisation: 19/11/2015, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 24, 2025 0

Human medicines European public assessment report (EPAR): Entresto, sacubitril,v...

Orphan designation: Adeno-associated virus serotype 9 containing the human RPE65 gene inherited retinal dystrophy due to defects in the RPE65 gene, 16/01/2025 Positive

Orphan designation: Adeno-associated virus serotype 9 c...

Feb 24, 2025 0

Orphan designation: Adeno-associated virus serotype 9 containing the human RPE65...

Human medicines European public assessment report (EPAR): Avastin, bevacizumab, Date of authorisation: 12/01/2005, Revision: 64, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 24, 2025 0

Human medicines European public assessment report (EPAR): Avastin, bevacizumab, ...

Orphan designation: N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2-yl)oxy)phenyl)-7-methyl-7H-pyrrolo[2,3-d] pyrimidin-6-yl)phenyl)methacrylamide hydrochloride Treatment of biliary tract cancer, 10/11/2022 Positive

Orphan designation: N-(4-(4-amino-5-(3-fluoro-4-((4-met...

Feb 24, 2025 0

Orphan designation: N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2-yl)oxy)phe...

Orphan designation: Arsenic trioxide Treatment of acute promyelocytic leukaemia, 13/12/2024 Positive

Orphan designation: Arsenic trioxide Treatment of acute...

Feb 24, 2025 0

Orphan designation: Arsenic trioxide Treatment of acute promyelocytic leukaemia,...

Orphan designation: human anti-promyostatin monoclonal antibody (apitegromab) Treatment of spinal muscular atrophy, 14/12/2018 Positive

Orphan designation: human anti-promyostatin monoclonal ...

Feb 24, 2025 0

Orphan designation: human anti-promyostatin monoclonal antibody (apitegromab) Tr...

Orphan designation: Lomitapide Treatment of familial chylomicronaemia, 17/12/2010 Positive

Orphan designation: Lomitapide Treatment of familial ch...

Feb 24, 2025 0

Orphan designation: Lomitapide Treatment of familial chylomicronaemia, 17/12/201...

Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against apolipoprotein C-III mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues Treatment of familial chylomicronaemia syndrome, 19/07/2021 Positive

Orphan designation: Synthetic double-stranded siRNA oli...

Feb 24, 2025 0

Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed aga...

Kisqali

Feb 24, 2025 0

Kisqali

World Health Organization (WHO)

World Health Organization (WHO)

Feb 21, 2025 0

World Health Organization (WHO)

Consolidated 3-year rolling work plan for the Oncology ...

Feb 21, 2025 0

Consolidated 3-year rolling work plan for the Oncology Working Party : January 2...

Oncology Working Party

Oncology Working Party

Feb 21, 2025 0

Oncology Working Party

Infectious Diseases Working Party (IDWP) consolidated 3...

Feb 21, 2025 0

Infectious Diseases Working Party (IDWP) consolidated 3-year rolling work plan 2...

Infectious Diseases Working Party

Infectious Diseases Working Party

Feb 21, 2025 0

Infectious Diseases Working Party

Funding

Feb 21, 2025 0

Funding

Agenda of the COMP meeting 3-5 December 2024

Feb 21, 2025 0

Agenda of the COMP meeting 3-5 December 2024

41
42
43
44
45

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.