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10+20+30 milligram(s) Film-coated tablet

Amgen Europe B.V.EU/1/14/981/001

Main Information

Trade NameOtezla
Active SubstancesApremilast
Strength10+20+30 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderAmgen Europe B.V.
Licence NumberEU/1/14/981/001

Group Information

ATC CodeL04AA32 apremilast


Licence Issued
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


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