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Otezla

30 milligram(s) Film-coated tablet

Amgen Europe B.V.EU/1/14/981/002-003

Main Information

Trade NameOtezla
Active SubstancesApremilast
Strength30 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderAmgen Europe B.V.
Licence NumberEU/1/14/981/002-003

Group Information

ATC CodeL04AA32 apremilast

Status

Authorised/WithdrawnAuthorised
Licence Issued15/02/2015
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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