Review of transparency rules for the EU Clinical Trials Information System (CTIS)
Submitted by Anonymous (not verified) on 24 February 2025 - 12:30
Review of transparency rules for the EU Clinical Trials Information System (CTIS)
Development of the Clinical Trials Information System
Submitted by Anonymous (not verified) on 24 February 2025 - 12:29
Development of the Clinical Trials Information System
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
Submitted by Anonymous (not verified) on 24 February 2025 - 11:00
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Submitted by Anonymous (not verified) on 24 February 2025 - 11:00
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Marketing authorisation application (MAA) - pre-submission interactions form
Submitted by Anonymous (not verified) on 24 February 2025 - 10:20
Marketing authorisation application (MAA) - pre-submission interactions form
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications
Submitted by Anonymous (not verified) on 24 February 2025 - 10:20
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications: document with track changes
Submitted by Anonymous (not verified) on 24 February 2025 - 10:19
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications: document with track changes
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
Submitted by Anonymous (not verified) on 24 February 2025 - 9:49
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: 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
Submitted by Anonymous (not verified) on 24 February 2025 - 9:40
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: Arsenic trioxide Treatment of acute promyelocytic leukaemia, 13/12/2024 Positive
Submitted by Anonymous (not verified) on 24 February 2025 - 9:20
Orphan designation: Arsenic trioxide Treatment of acute promyelocytic leukaemia, 13/12/2024 Positive