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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1433281
Name of medicinal product: AFINITOR
Active substances:
Everolimus
Estonian, English, Latin
ATC code: L01EG02
Dosage form: tablet
Route of administration: oral use
Strengh: 5mg
Amount in package: 30TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Hormone receptor-positive advanced breast cancer Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. Neuroendocrine tumours of pancreatic origin Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. Neuroendocrine tumours of gastrointestinal or lung origin Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1). Renal cell carcinoma Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: April 24, 2024
Marketing authorization holder: Novartis Europharm Limited 
Marketing authorization number: EU/1/09/538 
Marketing authorization issued on: August 3, 2009 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05.04.2024     Yes  C78-C78; C25-C25; C34-C34; C16-C20  Onkoloog  No  until 4 years  patsientidele, kellel ravi alustamise näidustatus everoliimusega on hinnatud konsiiliumi (vähemalt 2 onkoloogi) poolt vastavaks järgmistele kriteeriumidele: diagnoositud kaugelearenenud kõrgelt diferentseerunud (täielikult) mitteresetseeritav progresseeruva kuluga seedetraktist, kopsust või pankreasest lähtunud neuroendokriinne kasvaja ning süsteemne keemiaravi ja/või ravi somatostatiini analoogiga on vastunäidustatud või osutunud ebaefektiivseks 
100  05.04.2024     Yes  C78-C78; C25-C25; C34-C34; C16-C20  Onkoloog  No     patsientidele, kellel ravi alustamise näidustatus everoliimusega on hinnatud konsiiliumi (vähemalt 2 onkoloogi) poolt vastavaks järgmistele kriteeriumidele: diagnoositud kaugelearenenud kõrgelt diferentseerunud (täielikult) mitteresetseeritav progresseeruva kuluga seedetraktist, kopsust või pankreasest lähtunud neuroendokriinne kasvaja ning süsteemne keemiaravi ja/või ravi somatostatiini analoogiga on vastunäidustatud või osutunud ebaefektiivseks 
Reference price: 719,70 EUR 
Under reference price: No 
Reference price of daily dose: 47,98 EUR 
Entry/Changing date: April 4, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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