P/0159/2023 : EMA decision of 12 May 2023 on on the acceptance of a modification of an agreed paediatric investigation plan for efgartigimod alfa (Vyvgart), (EMEA-002597-PIP05-21-M01) Reference Number: EMA/170275/2023
P/0164/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for iptacopan (EMEA- 002705-PIP01-19-M01) Reference Number: EMA/160444/2023
P/0166/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain (EMEA-002942-PIP02-20-M01) Reference Number: …
Orchard Therapeutics (Netherlands) B.V. regulatory@orchard-tx.com Tel. +44 (0) 20 3808 8286
P/0197/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for odronextamab (EMEA-003149-PIP01-21-M01) Reference Number: EMA/210429/2023
Overview Grasustek is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer chemotherapy and can leave patients vulnerable to infections. It is given …
Duloxetine Zentiva is available as gastroresistant capsules (30 and 60 mg). ‘Gastroresistant’ means that the capsules’ contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being …
A confidentiality arrangement between the EMA, the European Commission's Directorate-General for Health and Food Safety (DG SANTE) and the World Health Organization (WHO) has been in place since 1 September 2015. This complements cooperation between …
This guideline is under review, see concept paper below. This guideline provides guidance on the clinical evaluation of the clinical investigation of medicinal products for the treatment of psoriatic arthritis. It describes patient characteristics and …
During the COVID-19 pandemic, the EMA Emergency Task Force (ETF) issued two guidance documents on regulatory requirements for COVID-19 vaccines. The first, issued in November 2020, covered clinical requirements for COVID-19 vaccine approval, and the second …
Committee for medicinal products for veterinary use summary of opinion: Zactran: International Non-proprietary Names (INN): Gamithromycin AdoptedReference Number: EMEA/CVMP/220772/2008
English (EN) (81.94 KB - PDF) First published: 18/01/2007Last updated: 28/06/2024
English (EN) (81.94 KB - PDF) First published: 23/05/2011Last updated: 28/06/2024
Committee for medicinal products for veterinary use summary of opinion: Palladia: International Non-proprietary Names (INN): Toceranib AdoptedReference Number: EMEA/CVMP/319738/2009
English (EN) (81.94 KB - PDF) First published: 05/10/2006Last updated: 28/06/2024
English (EN) (81.94 KB - PDF) First published: 25/03/2008Last updated: 28/06/2024
English (EN) (81.94 KB - PDF) First published: 28/02/2020Last updated: 28/06/2024
Committee for medicinal products for veterinary use summary of opinion: Onisor: International Non-proprietary Name (INN): Robenacoxib AdoptedReference Number: EMEA/CVMP/508377/2008
Committee for medicinal products for veterinary use summary of opinion: Naxcel: International Non-proprietary Name (INN): Ceftiofur AdoptedReference Number: EMEA/CVMP/405655/2009
English (EN) (81.94 KB - PDF) First published: 14/08/2007Last updated: 28/06/2024
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