Name |
Kazak 25 mg otopina za injekciju u napunjenoj štrcaljki |
Marketing Authorisation Number |
HR-H-853136565 |
Active Substance |
metotreksat |
Composition |
svaka štrcaljka sa 0,667 ml otopine sadrži 25 mg metotreksata |
Pharmaceutical Form |
Otopina za injekciju u napunjenoj štrcaljki |
Manufacturer |
Basic Pharma Manufacturing BV, JT Gellen, Nizozemska |
Marketing Authorisation Holder |
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
Marketing Authorisation Date |
10.07.2024 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/23-02/176 |
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 |
L04AX03 |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |