Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
Opzelura 15 mg/g cream.
| Pharmaceutical Form |
|---|
|
Cream. White to off-white cream. |
One gram of cream contains 15 mg of ruxolitinib (as phosphate).
Excipients with known effect:
Propylene glycol (E1520), 150 mg/g of cream
Cetyl alcohol, 30 mg/g of cream
Stearyl alcohol, 17.5 mg/g of cream
Methyl parahydroxybenzoate (E218), 1 mg/g of cream
Propyl parahydroxybenzoate, 0.5 mg/g of cream
Butylated hydroxytoluene (as an antioxidant in paraffin, white soft) (E321)
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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 |
|---|
|
Butylated hydroxytoluene (as an antioxidant in paraffin, white soft) (E321) |
Laminate tube with an inner lining of low-density and high-density polyethylene with a polypropylene cap, or aluminium tube with internal lacquer coating with a polypropylene puncture cap.
Tube of 100 g. One tube per carton.
Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
EU/1/23/1726/001
EU/1/23/1726/002
Date of first authorisation: 19 April 2023
| Drug | Countries | |
|---|---|---|
| OPZELURA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, United Kingdom, United States |
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