| Name |
Ibuprofen B. Braun 400 mg otopina za infuziju |
| Marketing Authorisation Number |
HR-H-783053521 |
| Active Substance |
ibuprofen |
| Composition |
1 ml otopine sadrži 4 mg ibuprofena jedna bočica od 100 mI sadrži 400 mg ibuprofena |
| Pharmaceutical Form |
Otopina za infuziju |
| Manufacturer |
B. Braun Medical S.A., Rubi (Barcelona), Španjolska |
| Marketing Authorisation Holder |
B. Braun Melsungen AG, Carl-Braun-Str. 1, Melsungen, Njemačka |
| Marketing Authorisation Date |
30.09.2024 |
| MA Period of Validity |
30.09.2029 |
| Classification Number |
UP/I-530-09/24-01/220 |
| Registration Number |
381-12-01/171-24-07 |
| 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 |
M01AE01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |