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 |