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Herbal medicinal product: Allii sativi bulbus, Allium sativum L., F: Assessment finalised

Herbal medicinal product: Allii sativi bulbus, Allium s...

Apr 15, 2025 0

Herbal medicinal product: Allii sativi bulbus, Allium sativum L., F: Assessment ...

Herbal medicinal product: Arnicae flos, Arnica montana L., F: Assessment finalised

Herbal medicinal product: Arnicae flos, Arnica montana ...

Apr 15, 2025 0

Herbal medicinal product: Arnicae flos, Arnica montana L., F: Assessment finalised

Herbal medicinal product: Crataegi folium cum flore, Crataegus monogyna Jacq. (Lindm.), C. laevigata (Poir.) DC. or their hybrids; C. pentagyna Waldst. et Kit. ex Willd.; C. azarolus L., F: Assessment finalised

Herbal medicinal product: Crataegi folium cum flore, Cr...

Apr 15, 2025 0

Herbal medicinal product: Crataegi folium cum flore, Crataegus monogyna Jacq. (L...

Call for scientific data for the use in HMPC assessment...

Apr 15, 2025 0

Call for scientific data for the use in HMPC assessment work on Valerianae radix...

Herbal medicinal product: Valerianae radix and Passiflorae herba, Combination: Valeriana officinalis L. and Passiflora incarnata L., C: ongoing call for scientific data

Herbal medicinal product: Valerianae radix and Passiflo...

Apr 15, 2025 0

Herbal medicinal product: Valerianae radix and Passiflorae herba, Combination: V...

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 28, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 15, 2025 0

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (p...

Nitrosamines Safety Operational Expert Group

Nitrosamines Safety Operational Expert Group

Apr 15, 2025 0

Nitrosamines Safety Operational Expert Group

PSUSA/00000464/202407

PSUSA/00000464/202407

Apr 15, 2025 0

PSUSA/00000464/202407

Human medicines European public assessment report (EPAR): Capvaxive, pneumococcal polysaccharide conjugate vaccine (21-valent), Date of authorisation: 24/03/2025, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 14, 2025 0

Human medicines European public assessment report (EPAR): Capvaxive, pneumococca...

Human medicines European public assessment report (EPAR): Lyvdelzi (previously Seladelpar Gilead), Seladelpar lysine dihydrate, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 14, 2025 0

Human medicines European public assessment report (EPAR): Lyvdelzi (previously S...

Dynastat

Apr 14, 2025 0

Dynastat

Agenda of the CAT meeting 14-16 April 2025

Apr 14, 2025 0

Agenda of the CAT meeting 14-16 April 2025

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Date of authorisation: 15/01/2009, Revision: 51, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 14, 2025 0

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, ...

Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guideline

Evaluation of medicinal products indicated for treatmen...

Apr 14, 2025 0

Evaluation of medicinal products indicated for treatment of bacterial infections...

Human medicines European public assessment report (EPAR): Rezolsta, darunavir,cobicistat, Date of authorisation: 19/11/2014, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 14, 2025 0

Human medicines European public assessment report (EPAR): Rezolsta, darunavir,co...

Opinion/decision on a Paediatric investigation plan (PIP): Tenkasi (previously Orbactiv), oritavancin (diphosphate), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: P/0074/2024

Opinion/decision on a Paediatric investigation plan (PI...

Apr 14, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Tenkasi (previously O...

Human medicines European public assessment report (EPAR): Rinvoq, upadacitinib, Date of authorisation: 16/12/2019, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 14, 2025 0

Human medicines European public assessment report (EPAR): Rinvoq, upadacitinib, ...

Opinion/decision on a Paediatric investigation plan (PIP): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), Dinutuximab beta, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0076/2024

Opinion/decision on a Paediatric investigation plan (PI...

Apr 14, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Qarziba (previously D...

Product-information (QRD) templates - Human

Product-information (QRD) templates - Human

Apr 14, 2025 0

Product-information (QRD) templates - Human

Quality Review of Documents (QRD) annotated template v1...

Apr 14, 2025 0

Quality Review of Documents (QRD) annotated template v11: Draft for public consu...

Quality Review of Documents (QRD) annotated template v1...

Apr 14, 2025 0

Quality Review of Documents (QRD) annotated template v11: Draft for public consu...

Opinion/decision on a Paediatric investigation plan (PIP): Lokelma, sodium zirconium cyclosilicate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Metabolism and nutrition disorders, PIP number: P/0077/2024

Opinion/decision on a Paediatric investigation plan (PI...

Apr 14, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Lokelma, sodium zirco...

EMEA-001579-PIP01-13-M06

EMEA-001579-PIP01-13-M06

Apr 14, 2025 0

EMEA-001579-PIP01-13-M06

EMEA-002741-PIP01-20-M02

EMEA-002741-PIP01-20-M02

Apr 14, 2025 0

EMEA-002741-PIP01-20-M02

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