Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The 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). Otezla 10 mg film-coated tablets: Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side. Otezla 20 mg film-coated tablets: Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side. Otezla 30 mg film-coated tablets: 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.
Excipient(s) with known effect: Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate).
Each film-coated tablet contains 20 mg of apremilast.
Excipient(s) with known effect: Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate).
Each film-coated tablet contains 30 mg of apremilast.
Excipient(s) with known effect: 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 | |
|---|---|---|
| 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. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, IL-17 and other inflammatory cytokines. |
| List of Excipients |
|---|
|
Tablet core: Cellulose microcrystalline Film-coating: Poly (vinyl 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). |
Otezla treatment initiation packs:
PVC/aluminium foil blisters containing 27 film-coated tablets (4 × 10 mg, 23 × 20 mg).
PVC/aluminium foil blisters containing 27 film-coated tablets (4 × 10 mg, 4 × 20 mg, 19 × 30 mg).
Otezla 20 mg packs:
PVC/aluminium foil blisters containing 14 film-coated tablets, in a pack size of 56 tablets.
Otezla 30 mg packs:
PVC/aluminium foil blisters containing 14 film-coated tablets, in pack sizes of 56 tablets and 168 tablets.
Not all pack sizes may be marketed.
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Otezla 10 mg, 20 mg film-coated tablets (initiation pack):
EU/1/14/981/004
Otezla 10 mg, 20 mg, 30 mg film-coated tablets (initiation pack):
EU/1/14/981/001
Otezla 20 mg film-coated tablets:
EU/1/14/981/005 – pack size of 56 tablets
Otezla 30 mg film-coated tablets:
EU/1/14/981/002 – pack size of 56 tablets
EU/1/14/981/003 – pack size of 168 tablets
Date of first authorisation: 15 January 2015
Date of latest renewal: 23 August 2019
| Drug | Countries | |
|---|---|---|
| OTEZLA | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa |
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