| Name |
Glypressin 1 mg prašak i otapalo za otopinu za injekciju |
| Marketing Authorisation Number |
HR-H-413434003 |
| Active Substance |
terlipresinacetat |
| Composition |
jedna bočica sadrži 1 mg terlipresin acetata, što odgovara 0,86 mg terlipresina koncentracija pripremljene otopine je 0,2 mg terlipresin acetata/ml |
| Pharmaceutical Form |
prašak i otapalo za otopinu za injekciju |
| Manufacturer |
Ferring GmbH, Kiel, Njemačka |
| Marketing Authorisation Holder |
Ferring GmbH, Wittland 11, Kiel, Njemačka |
| Marketing Authorisation Date |
07.05.2019 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/19-02/47 |
| Registration Number |
381-12-01/30-19-04 |
| 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 |
H01BA04 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
