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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

EMEA-002338-PIP04-23

EMEA-002338-PIP04-23

Apr 14, 2025 0

EMEA-002338-PIP04-23

Eligible patients and consumers organisations

Eligible patients and consumers organisations

Apr 14, 2025 0

Eligible patients and consumers organisations

Opinion/decision on a Paediatric investigation plan (PIP): VidPrevtyn Beta, SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Vaccines, PIP number: P/0072/2024

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

Apr 14, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): VidPrevtyn Beta, SARS...

Human medicines European public assessment report (EPAR): Eliquis, apixaban, Date of authorisation: 18/05/2011, Revision: 35, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 14, 2025 0

Human medicines European public assessment report (EPAR): Eliquis, apixaban, Dat...

EMEA-003420-PIP01-23

EMEA-003420-PIP01-23

Apr 14, 2025 0

EMEA-003420-PIP01-23

EMEA-003423-PIP02-23

EMEA-003423-PIP02-23

Apr 14, 2025 0

EMEA-003423-PIP02-23

Recommendations of the Executive Steering Group on Shor...

Apr 14, 2025 0

Recommendations of the Executive Steering Group on Shortages and Safety of Medic...

Human medicines European public assessment report (EPAR): Trumenba, meningococcal group b vaccine (recombinant, adsorbed), Date of authorisation: 24/05/2017, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 14, 2025 0

Human medicines European public assessment report (EPAR): Trumenba, meningococca...

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