Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
Otezla 10 mg film-coated tablets.
Otezla 20 mg film-coated tablets.
Otezla 30 mg film-coated tablets.
Pharmaceutical Form |
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Film-coated tablet (tablet). Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side. Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side. Beige, diamond shaped 30 mg film-coated tablet of 12 mm length with “APR” engraved on one side and “30” on the opposite side. |
Each film-coated tablet contains 10 mg of apremilast.
Each film-coated tablet contains 20 mg of apremilast.
Each film-coated tablet contains 30 mg of apremilast.
Excipient(s) with known effect:
Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate).
Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate).
Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Apremilast |
Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. |
List of Excipients |
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Tablet core: Microcrystalline cellulose Film-coating: Polyvinyl alcohol The 20 mg tablets also contain iron oxide yellow (E172). The 30 mg tablets also contain iron oxide yellow (E172) and iron oxide black(E172). |
The treatment initiation pack contains 27 film-coated tablets (4 x10 mg, 4x 20 mg, 19 × 30 mg).
Not all pack sizes may be marketed
Celgene Europe B.V., Winthontlaan 6 N, 3526 KV Utrecht, Netherlands
EU/1/14/981/001
Date of first authorisation: 15 January 2015
Drug | Countries | |
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OTEZLA | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa |
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