Temazol 5 mg tvrde kapsule
| Name | Temazol 5 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-658101804 |
| Active Substance | temozolomid |
| Composition | jedna tvrda kapsula sadrži 5 mg temozolomida |
| Pharmaceutical Form | kapsula, tvrda |
| Manufacturer | Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Haupt Pharma Amareg GmbH, Regensburg, Njemačka |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 28.10.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/443 |
| Registration Number | 381-12-01/30-17-05 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01AX03 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
