Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Jakavi 5 mg tablets.
Jakavi 10 mg tablets.
Jakavi 15 mg tablets.
Jakavi 20 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Jakavi 5 mg tablets: Round curved white to almost white tablets of approximately 7.5 mm in diameter with “NVR” debossed on one side and “L5” debossed on the other side. Jakavi 10 mg tablets: Round curved white to almost white tablets of approximately 9.3 mm in diameter with “NVR” debossed on one side and “L10” debossed on the other side. Jakavi 15 mg tablets: Ovaloid curved white to almost white tablets of approximately 15.0 × 7.0 mm with “NVR” debossed on one side and “L15” debossed on the other side. Jakavi 20 mg tablets: Elongated curved white to almost white tablets of approximately 16.5 × 7.4 mm with “NVR” debossed one one side and “L20” debossed on the other side. |
Each tablet contains 5 mg ruxolitinib (as phosphate).
Excipient with known effect: Each tablet contains 71.45 mg lactose monohydrate.
Each tablet contains 10 mg ruxolitinib (as phosphate).
Excipient with known effect: Each tablet contains 142.90 mg lactose monohydrate.
Each tablet contains 15 mg ruxolitinib (as phosphate).
Excipient with known effect: Each tablet contains 214.35 mg lactose monohydrate.
Each tablet contains 20 mg ruxolitinib (as phosphate).
Excipient with known effect: Each tablet contains 285.80 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ruxolitinib |
Ruxolitinib is a selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 (IC50 values of 3.3 nM and 2.8 nM for JAK1 and JAK2 enzymes, respectively). These mediate the signalling of a number of cytokines and growth factors that are important for haematopoiesis and immune function. Ruxolitinib inhibits cytokine-induced STAT3 phosphorylation in whole blood from healthy subjects, MF patients and PV patients. |
| List of Excipients |
|---|
|
Cellulose, microcrystalline |
PVC/PCTFE/Aluminium blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets.
Not all pack sizes or types may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Jakavi 5 mg tablets: EU/1/12/773/004-006
Jakavi 10 mg tablets: EU/1/12/773/014-016
Jakavi 15 mg tablets: EU/1/12/773/007-009
Jakavi 20 mg tablets: EU/1/12/773/010-012
Date of first authorisation: 23 August 2012
Date of latest renewal: 24 April 2017
| Drug | Countries | |
|---|---|---|
| JAKAVI | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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