Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1787609
Name of medicinal product: EVEROLIMUS NORAMEDA
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 [product name] 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 [product name] 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 [product name] 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 [product name] 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):  (last updated February 7, 2023)
Package information leaflet (PIL): EST  (last updated November 23, 2022)
Labelling:  (last updated September 27, 2022)
Last imported to Estonia: March 15, 2024
Marketing authorization holder: Norameda UAB 
Marketing authorization number: 990919 
Marketing authorization issued on: July 2, 2019 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
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: Yes 
Reference price of daily dose: 47,98 EUR 
Entry/Changing date: November 13, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

You can download Acrobat Reader fromhere