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Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets



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

Main Information

Trade NameOtezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets
Active SubstancesApremilast
Apremilast
Apremilast
Dosage FormFilm-coated tablet
Licence HolderAmgen Europe B.V.
Licence NumberEU/1/14/981/001

Group Information

ATC CodeL04AA32 apremilast

Status

License statusAuthorised
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

Documents

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