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Human medicines European public assessment report (EPAR): Ambrisentan Viatris (previously Ambrisentan Mylan), ambrisentan, Date of authorisation: 20/06/2019, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

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

Guideline on 5 assessment and reporting of mechanistic models used in 6 the context of model informed drug development

Guideline on 5 assessment and reporting of mechanistic ...

Feb 14, 2025 0

Guideline on 5 assessment and reporting of mechanistic models used in 6 the cont...

QRD veterinary product-information template version 9.1

Feb 14, 2025 0

QRD veterinary product-information template version 9.1

QRD veterinary product-information highlighted template...

Feb 14, 2025 0

QRD veterinary product-information highlighted template version 9.1

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, European Medicines Agency, Amsterdam, the Netherlands, from 12 May 2025 to 16 May 2025

Mandatory use of ISO/ICH E2B(R3) individual case safety...

Feb 14, 2025 0

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: han...

PSUSA/00009236/202406

PSUSA/00009236/202406

Feb 13, 2025 0

PSUSA/00009236/202406

Human medicines European public assessment report (EPAR): Bortezomib Fresenius Kabi, bortezomib, Date of authorisation: 14/11/2019, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

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Human medicines European public assessment report (EPAR): Bortezomib Fresenius K...

PSUSA/00000342/202407

PSUSA/00000342/202407

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PSUSA/00000342/202407

PSUSA/00010605/202407

PSUSA/00010605/202407

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PSUSA/00010605/202407

PSUSA/00010252/202406

PSUSA/00010252/202406

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PSUSA/00010252/202406

PSUSA/00010184/202406

PSUSA/00010184/202406

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PSUSA/00010184/202406

Human medicines European public assessment report (EPAR): Tabrecta, capmatinib, Date of authorisation: 20/06/2022, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 13, 2025 0

Human medicines European public assessment report (EPAR): Tabrecta, capmatinib, ...

Human medicines European public assessment report (EPAR): Docetaxel Accord, docetaxel, Date of authorisation: 22/05/2012, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 13, 2025 0

Human medicines European public assessment report (EPAR): Docetaxel Accord, doce...

Opinion/decision on a Paediatric investigation plan (PIP): Ervebo, Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations;Vaccines, PIP number: P/0495/2023

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

Feb 13, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Ervebo, Ebola Zaire V...

EU Innovation Network (EU-IN)

EU Innovation Network (EU-IN)

Feb 13, 2025 0

EU Innovation Network (EU-IN)

EMEA-003174-PIP01-21-M01

EMEA-003174-PIP01-21-M01

Feb 13, 2025 0

EMEA-003174-PIP01-21-M01

Human medicines European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm, dimethyl fumarate, Date of authorisation: 22/04/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

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Human medicines European public assessment report (EPAR): Dimethyl fumarate Neur...

Human medicines European public assessment report (EPAR): Nimenrix, meningococcal groups A, C, W-135 and Y conjugate vaccine, Date of authorisation: 20/04/2012, Revision: 41, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 13, 2025 0

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

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR...

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Human medicines European public assessment report (EPAR): Ruxience, rituximab, D...

EMEA-003469-PIP01-23

EMEA-003469-PIP01-23

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EMEA-003469-PIP01-23

Human medicines European public assessment report (EPAR): Ozempic, semaglutide, Date of authorisation: 08/02/2018, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 13, 2025 0

Human medicines European public assessment report (EPAR): Ozempic, semaglutide, ...

EMEA-003496-PIP01-23

EMEA-003496-PIP01-23

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EMEA-003496-PIP01-23

EMEA-003396-PIP01-23

EMEA-003396-PIP01-23

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EMEA-003396-PIP01-23

EMEA-002674-PIP01-19

EMEA-002674-PIP01-19

Feb 13, 2025 0

EMEA-002674-PIP01-19

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