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Human medicines European public assessment report (EPAR): Competact, pioglitazone,metformin, Date of authorisation: 28/07/2006, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

Human medicines European public assessment report (EPAR): Competact, pioglitazon...

Amended Biologics Working Party Vaccines Quality Operat...

Apr 9, 2025 0

Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OE...

Human medicines European public assessment report (EPAR): Vyloy, Zolbetuximab, Date of authorisation: 19/09/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

Human medicines European public assessment report (EPAR): Vyloy, Zolbetuximab, D...

Human medicines European public assessment report (EPAR): Besremi, ropeginterferon alfa-2b, Date of authorisation: 15/02/2019, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

Human medicines European public assessment report (EPAR): Besremi, ropeginterfer...

Human medicines European public assessment report (EPAR): Ronapreve, casirivimab,imdevimab, Date of authorisation: 12/11/2021, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

Human medicines European public assessment report (EPAR): Ronapreve, casirivimab...

Human medicines European public assessment report (EPAR): Talmanco (previously Tadalafil Generics), tadalafil, Date of authorisation: 09/01/2017, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

Human medicines European public assessment report (EPAR): Talmanco (previously T...

Human medicines European public assessment report (EPAR): Fintepla, fenfluramine, Date of authorisation: 18/12/2020, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

Human medicines European public assessment report (EPAR): Fintepla, fenfluramine...

Human medicines European public assessment report (EPAR): Ixchiq, Chikungunya vaccine (live), Date of authorisation: 28/06/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

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

Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Date of authorisation: 19/06/2015, Revision: 65, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Dat...

Minutes of the PRAC meeting 28-31 October 2024

Apr 9, 2025 0

Minutes of the PRAC meeting 28-31 October 2024

Minutes of the PRAC meeting 2-5 September 2024

Apr 9, 2025 0

Minutes of the PRAC meeting 2-5 September 2024

Minutes of the PRAC meeting 13-16 May 2024

Apr 9, 2025 0

Minutes of the PRAC meeting 13-16 May 2024

Human medicines European public assessment report (EPAR): Quinsair, levofloxacin, Date of authorisation: 25/03/2015, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

Human medicines European public assessment report (EPAR): Quinsair, levofloxacin...

Orphan designation: imetelstat sodium Treatment of myelodysplastic syndromes, 27/07/2020 Positive

Orphan designation: imetelstat sodium Treatment of myel...

Apr 9, 2025 0

Orphan designation: imetelstat sodium Treatment of myelodysplastic syndromes, 27...

Emergency Task Force (ETF) documents

Emergency Task Force (ETF) documents

Apr 9, 2025 0

Emergency Task Force (ETF) documents

Human medicines European public assessment report (EPAR): Rasagiline ratiopharm, rasagiline, Date of authorisation: 12/01/2015, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 9, 2025 0

Human medicines European public assessment report (EPAR): Rasagiline ratiopharm,...

ICH Guideline M13B on bioequivalence for immediate rele...

Apr 9, 2025 0

ICH Guideline M13B on bioequivalence for immediate release solid oral dosage for...

ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guideline

ICH Guideline M13B on bioequivalence for immediate-rele...

Apr 9, 2025 0

ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage for...

Orphan designation: Unesbulin Treatment of soft tissue sarcoma, 10/12/2021 Withdrawn

Orphan designation: Unesbulin Treatment of soft tissue ...

Apr 9, 2025 0

Orphan designation: Unesbulin Treatment of soft tissue sarcoma, 10/12/2021 Withd...

Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral sclerosis, 16/12/2019 Withdrawn

Orphan designation: Lactobacillus plantarum Treatment o...

Apr 9, 2025 0

Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral scl...

Orphan designation: Alrefimotide acetate,riletamotide acetate,tapderimotide acetate Treatment of mesothelioma, 21/03/2024 Withdrawn

Orphan designation: Alrefimotide acetate,riletamotide a...

Apr 9, 2025 0

Orphan designation: Alrefimotide acetate,riletamotide acetate,tapderimotide acet...

Orphan designation: Glofitamab Treatment of diffuse large B-cell lymphoma, 15/10/2021 Withdrawn

Orphan designation: Glofitamab Treatment of diffuse lar...

Apr 9, 2025 0

Orphan designation: Glofitamab Treatment of diffuse large B-cell lymphoma, 15/10...

Human medicines European public assessment report (EPAR): Loqtorzi, Toripalimab, Date of authorisation: 19/09/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 8, 2025 0

Human medicines European public assessment report (EPAR): Loqtorzi, Toripalimab,...

Human medicines European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand), oxybutynin, Date of authorisation: 15/06/2004, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR...

Apr 8, 2025 0

Human medicines European public assessment report (EPAR): Kentera (previously Ox...

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