| Name |
Traneksamatna kiselina Alpha-Medical 100 mg/ml otopina za injekciju |
| Marketing Authorisation Number |
HR-H-250950979 |
| Active Substance |
traneksamatna kiselina |
| Composition |
jedan ml otopine sadrži 100 mg traneksamatne kiseline |
| Pharmaceutical Form |
otopina za injekciju |
| Packaging [MA Number for Packaging] |
10 ampula sa 5 ml otopine, u kutiji [HR-H-250950979-01]
|
| Manufacturer |
Formula Pharmazeutische und chemische Entwicklungs GmbH, Berlin, Njemačka |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
30.11.2020 |
| MA Period of Validity |
30.11.2025 |
| Classification Number |
UP/I-530-09/18-01/162 |
| Registration Number |
381-12-01/38-20-15 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
B02AA02 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
