| Name |
Ikatibant Teva 30 mg otopina za injekciju u napunjenoj štrcaljki |
| Marketing Authorisation Number |
HR-H-164726004 |
| Active Substance |
ikatibantacetat |
| Composition |
jedna napunjena štrcaljka od 3 ml sadrži ikatibantacetat što odgovara 30 mg ikatibanta jedan ml otopine sadrži 10 mg ikatibanta |
| Pharmaceutical Form |
otopina za injekciju u napunjenoj štrcaljki |
| Manufacturer |
Merckle GmbH, Blaubeuren, Njemačka |
| Marketing Authorisation Holder |
Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date |
05.07.2021 |
| MA Period of Validity |
05.07.2026 |
| Classification Number |
UP/I-530-09/20-01/147 |
| Registration Number |
381-12-01/70-21-04 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product on medical prescription for renewable delivery
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
B06AC02 |
| Marketing status |
Marketed |
| Shortage status |
Actual |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
