Medicinal Products

Comboval 1000 mg/300 mg otopina za infuziju

Name Comboval 1000 mg/300 mg otopina za infuziju
Former Name Paracetamol/Ibuprofen Vale 1000 mg/300 mg otopina za infuziju
Marketing Authorisation Number HR-H-242220399
Active Substance paracetamol
ibuprofennatrij dihidrat
Composition 1 ml otopine za injekciju sadrži 10 mg paracetamola i 3 mg ibuprofena (u obliku natrijevog dihidrata)
Pharmaceutical Form otopina za infuziju
Manufacturer S.M.Farmaceutici S.R.L., Tito - Potenza, Italija
Marketing Authorisation Holder AFT Pharmaceuticals (EUR) Limited, Sinnottstown Business Park, Sinnottstown Lane, Drinagh, Wexford, Irska
Marketing Authorisation Date 25.08.2025
MA Period of Validity unlimited
Classification Number UP/I-530-09/24-02/95
Registration Number 381-12-01/171-25-11
Prescription Medicinal product subject to medical prescription
Type of prescription Medicinal product subject to restricted medical prescription
Distribution Supply through pharmacies (community)
Advertising to general public not allowed
ATC Code N02BE51
Marketing status Marketed
Shortage status No shortage
SmPC download
PL download
Public Assessment Report download

Packaging

Back