Valcyte 50 mg/ml prašak za oralnu otopinu
| Name | Valcyte 50 mg/ml prašak za oralnu otopinu |
|---|---|
| Marketing Authorisation Number | HR-H-809762522 |
| Active Substance | valganciklovirklorid |
| Composition | jedna boca sadrži 5,5 g valganciklovirklorida po 12 g praška za oralnu otopinu 1 ml rekonstituirane otopine sadrži 50 mg valganciklovira (u obliku klorida) |
| Pharmaceutical Form | prašak za oralnu otopinu |
| Manufacturer | Prestige Promotion Verkaufsförderung & Werbeservice GmbH, Kleinostheim, Bavaria, Njemačka Prestige Promotion Verkaufsförderung & Werbeservice GmbH, Alzenau, Njemačka Cheplapharm Arzneimittel GmbH, Greifswald, Njemačka |
| Marketing Authorisation Holder | Cheplapharm Arzneimittel GmbH, Ziegelhof 24, Greifswald, Njemačka |
| Marketing Authorisation Date | 04.11.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/18-02/86 |
| Registration Number | 381-12-01/70-22-24 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J05AB14 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
