Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1716386
Name of medicinal product: VINORELBINE ACCORD
Active substances:
Vinorelbine
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 adults in the treatment of: - As a single agent in patients with metastatic breast cancer (stage 4) in which chemotherapy with anthracycline and taxane has failed or is inadequate. - Non-small cell lung cancer (stage 3 or 4).
Safety features: Yes
Summary of product characteristics (SPC):  (last updated June 28, 2023)
Package information leaflet (PIL): EST  (last updated June 28, 2023)
Labelling:  (last updated March 20, 2019)
Last imported to Estonia: July 11, 2023
Marketing authorization holder: Accord Healthcare B.V. 
Marketing authorization number: 924316 
Marketing authorization issued on: December 7, 2016 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 4, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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