EMEA-003394-PIP01-23
Submitted by Anonymous (not verified) on 5 June 2025 - 9:44
EMEA-003394-PIP01-23
Human medicines European public assessment report (EPAR): Pelgraz Paediatric, pegfilgrastim, Status: Application withdrawn
Submitted by Anonymous (not verified) on 4 June 2025 - 16:22
Human medicines European public assessment report (EPAR): Pelgraz Paediatric, pegfilgrastim, Status: Application withdrawn
PSUSA/00010855/202408
Submitted by Anonymous (not verified) on 4 June 2025 - 16:10
PSUSA/00010855/202408
IVF Media G5 - Procedural steps and scientific information after initial consultation
Submitted by Anonymous (not verified) on 4 June 2025 - 15:00
IVF Media G5 - Procedural steps and scientific information after initial consultation
IVF Media G5 - Procedural steps and scientific information after initial consultation (archive)
Submitted by Anonymous (not verified) on 4 June 2025 - 14:59
IVF Media G5 - Procedural steps and scientific information after initial consultation (archive)
Human medicines European public assessment report (EPAR): Beqvez (previously Durveqtix), fidanacogene elaparvovec, Date of authorisation: 24/07/2024, Revision: 3, Status: Withdrawn
Submitted by Anonymous (not verified) on 4 June 2025 - 14:58
Human medicines European public assessment report (EPAR): Beqvez (previously Durveqtix), fidanacogene elaparvovec, Date of authorisation: 24/07/2024, Revision: 3, Status: Withdrawn
Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg)
Submitted by Anonymous (not verified) on 4 June 2025 - 13:23
Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg)
Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2
Submitted by Anonymous (not verified) on 4 June 2025 - 10:53
Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2
Pharmacovigilance Risk Assessment Committee (PRAC): 7 - 10 April 2025, European Medicines Agency, Amsterdam, the Netherlands, from 7 April 2025 to 10 April 2025
Submitted by Anonymous (not verified) on 4 June 2025 - 10:42
Pharmacovigilance Risk Assessment Committee (PRAC): 7 - 10 April 2025, European Medicines Agency, Amsterdam, the Netherlands, from 7 April 2025 to 10 April 2025
Minutes of the PRAC meeting 07-10 April 2025
Submitted by Anonymous (not verified) on 4 June 2025 - 10:39
Minutes of the PRAC meeting 07-10 April 2025