TYVERB Film-coated tablet Ref.[9043] Active ingredients: Lapatinib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Tyverb 250 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Oval, biconvex, yellow film-coated tablets, with “GS XJG” debossed on one side.

Qualitative and quantitative composition

Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lapatinib

Lapatinib, a 4-anilinoquinazoline, is an inhibitor of the intracellular tyrosine kinase domains of both EGFR (ErbB1) and of HER2 (ErbB2) receptors (estimated Kiapp values of 3nM and 13nM, respectively) with a slow off-rate from these receptors (half-life greater than or equal to 300 minutes). Lapatinib inhibits ErbB-driven tumour cell growth in vitro and in various animal models.

List of Excipients

Tablet core:

Microcrystalline cellulose
Povidone (K30)
Sodium starch glycolate (Type A)
Magnesium stearate

Tablet coating:

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

Pack sizes and marketing

Tyverb is supplied in either blister packs or bottles.

Blister packs:

Tyverb/capecitabine combination posology: Each pack of Tyverb contains 70 film-coated tablets in foil blisters (polyamide/aluminium/polyvinyl chloride/aluminium) of 10 tablets each. Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 5 tablets.

Multipacks contain 140 (2 packs of 70) film-coated tablets.

Tyverb/aromatase inhibitor combination posology: Each pack of Tyverb contains 84 film-coated tablets in foil blisters (polyamide/aluminium/polyvinyl chloride/aluminium) of 12 tablets each. Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 6 tablets.

Bottles:

Tyverb is also supplied in high density polyethylene bottles (HDPE) with a child resistant polypropylene closure containing 70, 84, 105 or 140 film-coated 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

EU/1/07/440/001-007

Date of first authorisation: 10 June 2008

Date of latest renewal: 17 February 2015

Drugs

Drug Countries
TYVERB Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom

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