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Besremi



AOP Orphan Pharmaceuticals AGEU/1/18/1352/002

Main Information

Trade NameBesremi
Active SubstancesRopeginterferon alfa-2b
Dosage FormSolution for injection in pre-filled syringe
Licence HolderAOP Orphan Pharmaceuticals AG
Licence NumberEU/1/18/1352/002

Group Information

ATC CodeL03AB15 ropeginterferon alfa-2b

Status

License statusAuthorised
Licence Issued15/02/2019
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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