Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Cibinqo 50 mg film-coated tablets.
Cibinqo 100 mg film-coated tablets.
Cibinqo 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Cibinqo 50 mg film-coated tablets: Pink, approximately 11 mm long and 5 mm wide oval tablet debossed with “PFE” on one side and “ABR 50” on the other. Cibinqo 100 mg film-coated tablets: Pink, approximately 9 mm in diameter round tablet debossed with “PFE” on one side and “ABR 100” on the other. Cibinqo 200 mg film-coated tablets: Pink, approximately 18 mm long and 8 mm wide oval tablet debossed with “PFE” on one side and “ABR 200” on the other. |
Each film-coated tablet contains 50 mg of abrocitinib.
Excipient with known effect:
Each film-coated tablet contains 1.37 mg of lactose monohydrate.
Each film-coated tablet contains 100 mg of abrocitinib.
Excipient with known effect:
Each film-coated tablet contains 2.73 mg of lactose monohydrate.
Each film-coated tablet contains 200 mg of abrocitinib.
Excipient with known effect:
Each film-coated tablet contains 5.46 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Abrocitinib |
Abrocitinib is a Janus kinase (JAK)1 inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of haematopoiesis and immune cell function. It is used for the treatment of moderate-to-severe atopic dermatitis in adults. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460i) Film-coat: Hypromellose (E464) |
Cibinqo 50 mg film-coated tablets:
High-density polyethylene (HDPE) bottle and polypropylene closure containing 14 or 30 film-coated tablets.
Polyvinylidene chloride (PVDC) blister with aluminium foil lidding film containing 7 film-coated tablets. Each pack contains 14, 28 or 91 film-coated tablets.
Cibinqo 100 mg film-coated tablets:
HDPE bottle and polypropylene closure containing 14 or 30 film-coated tablets.
PVDC blister with aluminium foil lidding film containing 7 film-coated tablets. Each pack contains 14, 28 or 91 film-coated tablets.
Cibinqo 200 mg film-coated tablets:
HDPE bottle and polypropylene closure containing 14 or 30 film-coated tablets.
PVDC blister with aluminium foil lidding film containing 7 film-coated tablets. Each pack contains 14, 28 or 91 film-coated tablets.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Cibinqo 50 mg film-coated tablets:
EU/1/21/1593/001
EU/1/21/1593/002
EU/1/21/1593/003
EU/1/21/1593/004
EU/1/21/1593/005
Cibinqo 100 mg film-coated tablets:
EU/1/21/1593/006
EU/1/21/1593/007
EU/1/21/1593/008
EU/1/21/1593/009
EU/1/21/1593/010
Cibinqo 200 mg film-coated tablets:
EU/1/21/1593/011
EU/1/21/1593/012
EU/1/21/1593/013
EU/1/21/1593/014
EU/1/21/1593/015
| Drug | Countries | |
|---|---|---|
| CIBINQO | Estonia, Finland, Croatia, Ireland, Israel, Japan, Poland, Romania, Turkey, United Kingdom |
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