Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1484467
Name of medicinal product: TYVERB
Active substances:
Lapatinib
Estonian, English, Latin
ATC code: L01EH01
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 250mg
Amount in package: 84TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Tyverb is indicated for the treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2); -in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1). -in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1). -in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study were not previously treated with trastuzumab or an aromatase inhibitor (see sections 4.4. and 5.1). No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Novartis Europharm Limited 
Marketing authorization number: EU/1/07/440 
Marketing authorization issued on: June 10, 2008 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: September 25, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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