Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1739808
Name of medicinal product: EVEROLIMUS KRKA
Active substances:
Everolimus
Estonian, English, Latin
ATC code: L01EG02
Dosage form: tablet
Route of administration: oral use
Strengh: 5mg
Amount in package: 10TK
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 June 30, 2023)
Package information leaflet (PIL): EST  (last updated June 30, 2023)
Labelling:  (last updated June 30, 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 969918 
Marketing authorization issued on: September 11, 2018 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: January 30, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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