VOTRIENT Film-coated tablets Ref.[7503] Active ingredients: Pazopanib

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

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.

Qualitative and quantitative composition

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
Microcrystalline cellulose
Povidone (K30)
Sodium starch glycolate

Tablet coating:

Hypromellose
Iron oxide red (E172)
Macrogol 400
Polysorbate 80
Titanium dioxide (E171)

Votrient 400 mg film-coated tablets:

Tablet core:

Magnesium stearate
Microcrystalline cellulose
Povidone (K30)
Sodium starch glycolate

Tablet coating:

Hypromellose
Macrogol 400
Polysorbate 80
Titanium dioxide (E171)

Pack sizes and marketing

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.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

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

Drugs

Drug Countries
VOTRIENT Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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