Template for sharing EMA documents by Industry to support reliance
Submitted by Anonymous (not verified) on 28 October 2025 - 13:29
Template for sharing EMA documents by Industry to support reliance
Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Date of authorisation: 14/11/2013, Revision: 24, Status: Authorised
Submitted by Anonymous (not verified) on 28 October 2025 - 13:09
Human medicines European public assessment report (EPAR): Abilify Maintena, aripiprazole, Date of authorisation: 14/11/2013, Revision: 24, Status: Authorised
Human medicines European public assessment report (EPAR): Multaq, dronedarone, Date of authorisation: 25/11/2009, Revision: 22, Status: Authorised
Submitted by Anonymous (not verified) on 28 October 2025 - 12:32
Human medicines European public assessment report (EPAR): Multaq, dronedarone, Date of authorisation: 25/11/2009, Revision: 22, Status: Authorised
Human medicines European public assessment report (EPAR): Kisunla, donanemab, Date of authorisation: 24/09/2025, Status: Authorised
Submitted by Anonymous (not verified) on 28 October 2025 - 11:45
Human medicines European public assessment report (EPAR): Kisunla, donanemab, Date of authorisation: 24/09/2025, Status: Authorised
Referral: Sodium oxybate-containing syrup and oral solution for alcohol dependence, sodium oxybate Article 31 referrals Under evaluation, 28/10/2025
Submitted by Anonymous (not verified) on 28 October 2025 - 10:00
Referral: Sodium oxybate-containing syrup and oral solution for alcohol dependence, sodium oxybate Article 31 referrals Under evaluation, 28/10/2025
Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Date of authorisation: 29/09/2000, Revision: 57, Status: Authorised
Submitted by Anonymous (not verified) on 28 October 2025 - 9:20
Human medicines European public assessment report (EPAR): Keppra, levetiracetam, Date of authorisation: 29/09/2000, Revision: 57, Status: Authorised
Agenda of the PRAC meeting 27 - 30 October 2025
Submitted by Anonymous (not verified) on 27 October 2025 - 16:27
Agenda of the PRAC meeting 27 - 30 October 2025
EMEA-002712-PIP01-19-M01
Submitted by Anonymous (not verified) on 27 October 2025 - 16:25
EMEA-002712-PIP01-19-M01
EMEA-002287-PIP01-17-M03
Submitted by Anonymous (not verified) on 27 October 2025 - 16:20
EMEA-002287-PIP01-17-M03
Human medicines European public assessment report (EPAR): Fanskya, Mozafancogene autotemcel, Status: Application withdrawn
Submitted by Anonymous (not verified) on 27 October 2025 - 16:12
Human medicines European public assessment report (EPAR): Fanskya, Mozafancogene autotemcel, Status: Application withdrawn