Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Jakavi 5 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear, colourless to light yellow solution, which may have some small colourless particles or a small amount of sediment in it. |
1 ml oral solution contains 5 mg ruxolitinib (as phosphate).
60 ml oral solution in bottle contains 300 mg ruxolitinib (as phosphate).
Excipients with known effect:
Each ml of the oral solution contains 150 mg propylene glycol, 1.2 mg methyl parahydroxybenzoate and 0.4 mg propyl parahydroxybenzoate (see section 4.4).
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. These mediate the signalling of a number of cytokines and growth factors that are important for haematopoiesis and immune function. |
| List of Excipients |
|---|
|
Propylene glycol (E1520) |
Jakavi oral solution is available in 70 ml amber glass bottles with a white polypropylene child-resistant screw cap closure. Packs containing one bottle of 60 ml oral solution, two 1 ml polypropylene oral syringes and one low density polypropylene press-in bottle adapter. The oral syringes are equipped with plunger O-rings and printed with 0.1 ml graduation marks.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/12/773/017
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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