| Name |
Ospen K 1000000 IU filmom obložene tablete |
| Former Name |
Pen-Vi-K 1 000 000 i.j. filmom obložena tableta |
| Marketing Authorisation Number |
HR-H-169107338 |
| Active Substance |
fenoksimetilpenicilinkalij |
| Composition |
jedna filmom obložena tableta sadrži 1 000 000 IU odnosno 654 mg fenoksimetilpenicilinkalija što odgovara 590 mg fenoksimetilpenicilina i oko 64 mg kalija |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
Sandoz GmbH, Kundl, Austrija |
| Marketing Authorisation Holder |
Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date |
27.11.2020 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/17-02/602 |
| Registration Number |
381-12-01/38-20-09 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for non-renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
J01CE02 |
| Marketing status |
Marketed |
| Shortage status |
Actual |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
