Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 29 July 2025 - 15:43
Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance
Entecavir product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 29 July 2025 - 15:40
Entecavir product-specific bioequivalence guidance
Human medicines European public assessment report (EPAR): Eklira Genuair, aclidinium bromide, Date of authorisation: 20/07/2012, Revision: 22, Status: Authorised
Submitted by Anonymous (not verified) on 29 July 2025 - 15:22
Human medicines European public assessment report (EPAR): Eklira Genuair, aclidinium bromide, Date of authorisation: 20/07/2012, Revision: 22, Status: Authorised
Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide,formoterol, Date of authorisation: 19/11/2014, Revision: 17, Status: Authorised
Submitted by Anonymous (not verified) on 29 July 2025 - 15:21
Human medicines European public assessment report (EPAR): Duaklir Genuair, aclidinium bromide,formoterol, Date of authorisation: 19/11/2014, Revision: 17, Status: Authorised
Record of data processing activity in the context of selection and recruitment procedures
Submitted by Anonymous (not verified) on 29 July 2025 - 12:37
Record of data processing activity in the context of selection and recruitment procedures
Summary of the Medicine Shortages SPOC Working Party meeting on 17 June 2025
Submitted by Anonymous (not verified) on 29 July 2025 - 8:47
Summary of the Medicine Shortages SPOC Working Party meeting on 17 June 2025
Nitrosamine impurities
Submitted by Anonymous (not verified) on 29 July 2025 - 8:35
Nitrosamine impurities
Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines
Submitted by Anonymous (not verified) on 29 July 2025 - 8:33
Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines
Human medicines European public assessment report (EPAR): Iqirvo, elafibranor, Date of authorisation: 19/09/2024, Revision: 2, Status: Authorised
Submitted by Anonymous (not verified) on 28 July 2025 - 15:38
Human medicines European public assessment report (EPAR): Iqirvo, elafibranor, Date of authorisation: 19/09/2024, Revision: 2, Status: Authorised
Human medicines European public assessment report (EPAR): Jubereq, denosumab, Date of authorisation: 26/05/2025, Status: Authorised
Submitted by Anonymous (not verified) on 28 July 2025 - 15:15
Human medicines European public assessment report (EPAR): Jubereq, denosumab, Date of authorisation: 26/05/2025, Status: Authorised