Name |
Ibuprofen Alkaloid 20 mg/ml oralna suspenzija |
Former Name |
Ibuprofen Alkaloid 100 mg/5 ml oralna suspenzija |
Marketing Authorisation Number |
HR-H-233790703 |
Active Substance |
ibuprofen |
Composition |
1 ml oralne suspenzije sadrži 20 mg ibuprofena |
Pharmaceutical Form |
oralna suspenzija |
Manufacturer |
Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija |
Marketing Authorisation Holder |
Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, Slovenija |
Marketing Authorisation Date |
29.03.2024 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/23-02/120 |
Registration Number |
381-12-01/70-24-03 |
Prescription |
Medicinal product subject to medical prescription |
Type of prescription |
neponovljivi recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
M01AE01 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |