Supporting innovation
Submitted by Anonymous (not verified) on 8 May 2025 - 15:00
Supporting innovation
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2025
Submitted by Anonymous (not verified) on 8 May 2025 - 14:30
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2025
Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines
Submitted by Anonymous (not verified) on 8 May 2025 - 14:20
Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines
Human medicines European public assessment report (EPAR): Givlaari, givosiran, Date of authorisation: 02/03/2020, Revision: 7, Status: Authorised
Submitted by Anonymous (not verified) on 8 May 2025 - 12:05
Human medicines European public assessment report (EPAR): Givlaari, givosiran, Date of authorisation: 02/03/2020, Revision: 7, Status: Authorised
Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 55, Status: Authorised
Submitted by Anonymous (not verified) on 8 May 2025 - 12:00
Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 55, Status: Authorised
Good Manufacturing Practice (GMP) / Distribution Practice Practice (GDP) Inspectors Working Group
Submitted by Anonymous (not verified) on 8 May 2025 - 11:22
Good Manufacturing Practice (GMP) / Distribution Practice Practice (GDP) Inspectors Working Group
Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products
Submitted by Anonymous (not verified) on 8 May 2025 - 11:20
Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products
Human medicines European public assessment report (EPAR): Tacforius, tacrolimus, Date of authorisation: 08/12/2017, Revision: 10, Status: Authorised
Submitted by Anonymous (not verified) on 8 May 2025 - 11:07
Human medicines European public assessment report (EPAR): Tacforius, tacrolimus, Date of authorisation: 08/12/2017, Revision: 10, Status: Authorised
Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Date of authorisation: 10/11/2017, Revision: 10, Status: Authorised
Submitted by Anonymous (not verified) on 8 May 2025 - 10:55
Human medicines European public assessment report (EPAR): Tremfya, guselkumab, Date of authorisation: 10/11/2017, Revision: 10, Status: Authorised
Human medicines European public assessment report (EPAR): Jentadueto, linagliptin,metformin hydrochloride, Date of authorisation: 19/07/2012, Revision: 23, Status: Authorised
Submitted by Anonymous (not verified) on 8 May 2025 - 10:54
Human medicines European public assessment report (EPAR): Jentadueto, linagliptin,metformin hydrochloride, Date of authorisation: 19/07/2012, Revision: 23, Status: Authorised