Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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. |
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 Tablet coating: Hypromellose |
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.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/07/440/001-007
Date of first authorisation: 10 June 2008
Date of latest renewal: 17 February 2015
| Drug | Countries | |
|---|---|---|
| TYVERB | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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