Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Votrient 200 mg film-coated tablets.
Votrient 400 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Votrient 200 mg film-coated tablets: Capsule-shaped, pink, film-coated tablet with GS JT debossed on one side. Votrient 400 mg film-coated tablets: Capsule-shaped, white, film-coated tablet with GS UHL debossed on one side. |
Votrient 200 mg film-coated tablets: Each film-coated tablet contains 200 mg pazopanib (as hydrochloride).
Votrient 400 mg film-coated tablets: Each film-coated tablet contains 400 mg pazopanib (as hydrochloride).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pazopanib |
Pazopanib is an orally administered, potent multi-target tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, platelet-derived growth factor (PDGFR) -α and -β, and stem cell factor receptor (c-KIT), with IC50 values of 10, 30, 47, 71, 84 and 74 nM, respectively. |
| List of Excipients |
|---|
|
Votrient 200 mg film-coated tablets: Tablet core: Magnesium stearate Tablet coating: Hypromellose Votrient 400 mg film-coated tablets: Tablet core: Magnesium stearate Tablet coating: Hypromellose |
Votrient 200 mg film-coated tablets: HDPE bottles with polypropylene child resistant closures containing either 30 or 90 tablets.
Votrient 400 mg film-coated tablets: HDPE bottles with polypropylene child resistant closures containing either 30 or 60 tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Votrient 200 mg film-coated tablets:
EU/1/10/628/001
EU/1/10/628/002
Votrient 400 mg film-coated tablets:
EU/1/10/628/003
EU/1/10/628/004
Date of first authorisation: 14 June 2010
Date of latest renewal: 08 January 2018
| Drug | Countries | |
|---|---|---|
| VOTRIENT | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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