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Human medicines European public assessment report (EPAR): Siiltibcy, Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10), Date of authorisation: 13/01/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 24, 2025 0

Human medicines European public assessment report (EPAR): Siiltibcy, Mycobacteri...

Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Blood and lymphatic system disorders, PIP number: P/0040/2024

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

Mar 24, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumoma...

QRD Form 2 and checklist for the submission of day +25 ...

Mar 24, 2025 0

QRD Form 2 and checklist for the submission of day +25 files - veterinary

Agenda of the CHMP meeting 24-27 March 2025

Mar 24, 2025 0

Agenda of the CHMP meeting 24-27 March 2025

Minutes of the CAT meeting 4-6 December 2024

Mar 24, 2025 0

Minutes of the CAT meeting 4-6 December 2024

Annex to 24-27 March 2025 CHMP Agenda

Mar 24, 2025 0

Annex to 24-27 March 2025 CHMP Agenda

Human medicines European public assessment report (EPAR): Vimkunya, Chikungunya vaccine (recombinant, adsorbed), Date of authorisation: 28/02/2025, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 24, 2025 0

Human medicines European public assessment report (EPAR): Vimkunya, Chikungunya ...

Pilot on advice from expert panels to manufacturers of ...

Mar 24, 2025 0

Pilot on advice from expert panels to manufacturers of high-risk medical devices...

EMEA-003541-PIP01-23

EMEA-003541-PIP01-23

Mar 21, 2025 0

EMEA-003541-PIP01-23

EMEA-003519-PIP01-23

EMEA-003519-PIP01-23

Mar 21, 2025 0

EMEA-003519-PIP01-23

EMEA-003520-PIP01-23

EMEA-003520-PIP01-23

Mar 21, 2025 0

EMEA-003520-PIP01-23

EMEA-003225-PIP01-22

EMEA-003225-PIP01-22

Mar 21, 2025 0

EMEA-003225-PIP01-22

EMEA-003425-PIP01-23

EMEA-003425-PIP01-23

Mar 21, 2025 0

EMEA-003425-PIP01-23

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: Skin and subcutaneous tissue disorders, PIP number: P/0062/2024

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

Mar 21, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib,...

Human medicines European public assessment report (EPAR): Veoza, fezolinetant, Date of authorisation: 07/12/2023, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 21, 2025 0

Human medicines European public assessment report (EPAR): Veoza, fezolinetant, D...

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Date of authorisation: 20/11/2018, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 21, 2025 0

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine...

Human medicines European public assessment report (EPAR): Polivy, polatuzumab vedotin, Date of authorisation: 16/01/2020, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 21, 2025 0

Human medicines European public assessment report (EPAR): Polivy, polatuzumab ve...

Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 21, 2025 0

Human medicines European public assessment report (EPAR): Drovelis, estetrol,dro...

Human medicines European public assessment report (EPAR): Enjaymo, sutimlimab, Date of authorisation: 15/11/2022, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 21, 2025 0

Human medicines European public assessment report (EPAR): Enjaymo, sutimlimab, D...

Human medicines European public assessment report (EPAR): Emadine, emedastine, Date of authorisation: 27/01/1999, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 21, 2025 0

Human medicines European public assessment report (EPAR): Emadine, emedastine, D...

Orphan designation: Octreotide acetate Treatment of acromegaly, 05/08/2013 Withdrawn

Orphan designation: Octreotide acetate Treatment of acr...

Mar 21, 2025 0

Orphan designation: Octreotide acetate Treatment of acromegaly, 05/08/2013 Withd...

Human medicines European public assessment report (EPAR): Mycapssa, octreotide, Date of authorisation: 02/12/2022, Status: Withdrawn

Human medicines European public assessment report (EPAR...

Mar 21, 2025 0

Human medicines European public assessment report (EPAR): Mycapssa, octreotide, ...

Mandate, objectives and rules of procedure for the CVMP...

Mar 21, 2025 0

Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance Workin...

Release notes - production release version 1.7.2514-3 -...

Mar 21, 2025 0

Release notes - production release version 1.7.2514-3 - 21 March 2025 - Veterina...

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