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OTEZLA

10+20+30 Milligram Film Coated Tablet

Celgene Europe LtdEU/1/14/981/001

Main Information

Trade NameOTEZLA
Active SubstancesAPREMILAST
Strength10+20+30 Milligram
Dosage FormFilm Coated Tablet
Licence HolderCelgene Europe Ltd
Licence NumberEU/1/14/981/001

Group Information

ATC CodeL04AA32 Selective immunosuppressants

Status

Authorised/WithdrawnAuthorised
Licence Issued15/02/2015
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

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