Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1753275
Name of medicinal product: BAVENCIO
Active substances:
Avelumab
Estonian, English, Latin
ATC code: L01FF04
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 20mg 1ml
Amount in package: 10ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: March 26, 2024
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Merck Europe B.V. 
Marketing authorization number: EU/1/17/1214 
Marketing authorization issued on: September 18, 2017 
Marketing authorization expires on: September 20, 2026 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 8, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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