Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
XELJANZ 5 mg film-coated tablets.
XELJANZ 10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Tofacitinib 5 mg film-coated tablets: White, round tablet of 7.9 mm diameter, debossed “Pfizer” on one side and “JKI 5” on the other. Tofacitinib 10 mg film-coated tablets: Blue, round tablet of 9.5 mm diameter, debossed “Pfizer” on one side and “JKI 10” on the other. |
Each film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Excipient with known effect:
Each film-coated tablet contains 59.44 mg of lactose.
Each film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Excipient with known effect:
Each film-coated tablet contains 118.88 mg of lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tofacitinib |
Tofacitinib is a potent, selective inhibitor of the JAK family. In human cells, tofacitinib preferentially inhibits signalling by heterodimeric cytokine receptors that associate with JAK3 and/or JAK1. Inhibition of JAK1 and JAK3 by tofacitinib attenuates signalling of interleukins and type I and type II interferons, which will result in modulation of the immune and inflammatory response. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film coat: Hypromellose 6cP (E464) |
XELJANZ 5 mg film-coated tablets:
HDPE bottles with silica gel desiccant and child-resistant polypropylene closure containing 60 or 180 film-coated tablets.
Aluminium foil/PVC backed aluminium foil blisters containing 14 film-coated tablets. Each pack contains 56, 112, or 182 film-coated tablets.
XELJANZ 10 mg film-coated tablets:
HDPE bottles with silica gel desiccant and child-resistant polypropylene closure containing 60 or 180 film-coated tablets.
Aluminium foil/PVC backed aluminium foil blisters containing 14 film-coated tablets. Each pack contains 56, 112, or 182 film-coated tablets.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/17/1178/001
EU/1/17/1178/002
EU/1/17/1178/003
EU/1/17/1178/004
EU/1/17/1178/005
EU/1/17/1178/006
EU/1/17/1178/007
EU/1/17/1178/008
EU/1/17/1178/009
EU/1/17/1178/014
Date of first authorisation: 22 March 2017
| Drug | Countries | |
|---|---|---|
| XELJANZ | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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