Source: European Medicines Agency (EU) Revision Year: 2024 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. JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Inhibition of JAK1 modulates the signalling pathways by preventing the phosphorylation and activation of STATs. |
| 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
Date of first authorisation: 09 December 2021
| Drug | Countries | |
|---|---|---|
| CIBINQO | Estonia, Finland, Croatia, Ireland, Israel, Japan, Poland, Romania, Turkey, United Kingdom |
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