What's new

What's new

PSUSA/00000166/202312

PSUSA/00000166/202312

21 November 2024

International Coalition of Medicines Regulatory Authorities (ICMRA)

International Coalition of Medicines Regulatory Authorities (ICMRA)

21 November 2024

Human medicines European public assessment report (EPAR): Palforzia, defatted powder of Arachis hypogaea L., semen (peanuts), Date of authorisation: 17/12/2020, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Palforzia, defatted powder of Arachis hypogaea L., semen (peanuts), Date of authorisation: 17/12/2020, Revision: 7, Status: Authorised

21 November 2024

Veterinary medicines European public assessment report (EPAR): Fevaxyn Pentofel, inactivated feline panleukopenia virus, calicivirus, rhinotracheitis virus, leukaemia virus and Chlamydophila felis, Status: Withdrawn (authorisation)

Veterinary medicines European public assessment report (EPAR): Fevaxyn Pentofel, inactivated feline panleukopenia virus, calicivirus, rhinotracheitis virus, leukaemia virus and Chlamydophila felis, Status: Withdrawn (authorisation)

21 November 2024

Human medicines European public assessment report (EPAR): Tenkasi (previously Orbactiv), oritavancin, Date of authorisation: 19/03/2015, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Tenkasi (previously Orbactiv), oritavancin, Date of authorisation: 19/03/2015, Revision: 16, Status: Authorised

20 November 2024

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 20, Status: Authorised

20 November 2024

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0451/2023

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0451/2023

20 November 2024

EMEA-003379-PIP01-22

EMEA-003379-PIP01-22

20 November 2024

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0446/2023

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Dermatology, PIP number: P/0446/2023

20 November 2024

EMEA-002705-PIP05-23

EMEA-002705-PIP05-23

20 November 2024