ProHance 0,5 mmol/ml otopina za injekciju u napunjenoj štrcaljki
| Name | ProHance 0,5 mmol/ml otopina za injekciju u napunjenoj štrcaljki |
|---|---|
| Marketing Authorisation Number | HR-H-986593014 |
| Active Substance | gadoteridol |
| Composition | 1 ml otopine za injekciju sadrži 279,3 mg gadoteridola (što odgovara 0,5 mmol/ml gadoteridola) |
| Pharmaceutical Form | otopina za injekciju u napunjenoj štrcaljki |
| Manufacturer | Bipso GmbH , Singen, Njemačka Bracco Imaging s.p.a., Colleretto Giocosa, Torino, Italija |
| Marketing Authorisation Holder | Bracco Imaging s.p.a., Via Egidio Folli 50, Milano, Italija |
| Marketing Authorisation Date | 18.04.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/23-02/154 |
| Registration Number | 381-12-01/70-24-03 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | V08CA04 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
