Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1235348
Name of medicinal product: VINORELBIN "EBEWE" 10MG/ML
Active substances:
Estonian, English, Latin
ATC code: L01CA04
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 10mg 1ml
Amount in package: 5ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Vinorelbine is indicated in the treatment of: - Non-small cell lung cancer (stage 3 or 4). - As single agent to patients with metastatic breast cancer (stage 4), where treatment with anthracycline- and taxane containing chemotherapy has failed or is not appropriate.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated March 13, 2024)
Package information leaflet (PIL): EST  (last updated March 13, 2024)
Labelling:  (last updated November 28, 2018)
Last imported to Estonia: January 18, 2024
Marketing authorization holder: Sandoz Pharmaceuticals d.d. 
Marketing authorization number: 524206 
Marketing authorization issued on: October 20, 2006 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 13, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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