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6 results
Medicine type
Biosimilar Remove Biosimilar filter
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Summary of opinion: Yesafili
aflibercept, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Tyenne
tocilizumab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Tyruko
natalizumab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Herwenda (new)
trastuzumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Direct healthcare professional communication (DHPC): Infliximab (Remicade, Flixabi, Inflectra, Remsima and Zessly): Use of live vaccines in infants exposed in utero or during breastfeeding
Active substance: infliximab, DHPC type: New contraindication, Last updated: 07/03/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pelgraz, pegfilgrastim
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002671-PIP02-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 10/05/2021, Last updated: 11/02/2022, Compliance check: X