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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | V08CA04 |
Medicinal product marketed in the Croatia | Ne |
SmPC | download |
PL | download |
Public Assessment Report | download |