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Pegasys
INN or common name: peginterferon alfa-2a
Therapeutic area (MeSH): Hepatitis C, Chronic; Hepatitis B, Chronic; Polycythemia Vera; Thrombocythemia, Essential
Marketing authorisation issued:
Last updated: 5 November 2025
Revision: 48
Medicine Human Authorised
EU/3/19/2203 - orphan designation for treatment of Netherton syndrome
Active substance: (S)-2-isobutyrylamino-pentanedioic acid 5-amide 1-{[(2S,5S,8S,11R,12S,15S,18S,21R)-2,8-bis-((S)-sec-butyl)-21-hydroxy-5-(4-hydroxy-benzyl)-15-isobutyl-4,11-dimethyl-3,6,9,13,16,22-hexaoxo-10-oxa-1,4,7,14,17-pentaaza-bicyclo[16.3.1]docos-12-yl]-amide}
Orphan designation status: Withdrawn
Date of designation:17 October 2019
Last updated: 30 June 2025
Orphan Human
Vipdomet
INN or common name: alogliptin; metformin
Therapeutic area (MeSH): Diabetes Mellitus, Type 2
Marketing authorisation issued:
Last updated: 19 May 2025
Revision: 13
Medicine Human Authorised
NeoRecormon
INN or common name: epoetin beta
Therapeutic area (MeSH): Kidney Failure, Chronic; Anemia; Cancer; Blood Transfusion, Autologous
Marketing authorisation issued:
Last updated: 2 May 2025
Revision: 35
Medicine Human Authorised
EMEA-003025-PIP03-23-M01 - paediatric investigation plan
Active substance: haematopoietic stem cells and blood progenitors umbilical cord-derived expanded with (1R,4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate (ECT-001-CB)
Therapeutic area: Blood and lymphatic system disorders
Pharmaceutical form(s): Dispersion for infusion
Route(s) of administration: Intravenous use
Decision number: P/0544/2023
Decision date: 20 December 2023
Decision type: PM: decision on the application for modification of an agreed PIP
Compliance check done: No
Last updated: 13 February 2025
PIP Human
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