Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Litfulo 50 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). Opaque hard capsules, yellow body and blue cap approximately 16 mm long and 6 mm wide, of which the body is printed with “RCB 50” and the cap is printed with “Pfizer” in black. |
Each hard capsule contains ritlecitinib tosylate equivalent to 50 mg ritlecitinib.
Excipient(s) with known effect: Each hard capsule contains 21.27 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ritlecitinib |
Ritlecitinib irreversibly and selectively inhibits Janus kinase (JAK) 3 and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family by blocking the adenosine triphosphate (ATP) binding site. JAK3 and TEC family mediated signalling pathways are both involved in alopecia areata pathogenesis, although complete pathophysiology is still not understood. |
| List of Excipients |
|---|
|
Hard capsule content: Cellulose microcrystalline Hard capsule shell: Hypromellose (E464) Printing ink: Shellac |
High-density polyethylene (HDPE) bottle with a silica gel desiccant and polypropylene closure containing 28 hard capsules.
OPA/Al/PVC/Al blisters containing 10 hard capsules. Each pack contains 30 or 90 hard capsules.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/23/1755/001
EU/1/23/1755/002
EU/1/23/1755/003
| Drug | Countries | |
|---|---|---|
| LITFULO | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, United Kingdom, United States |
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