Name |
Cisatrakurij Accordpharma 2 mg/ml otopina za injekciju/infuziju |
Marketing Authorisation Number |
HR-H-250543709 |
Active Substance |
cisatrakurij besilat |
Composition |
1 ml otopine za injekciju ili infuziju sadrži 2,68 mg cisatrakurij besilata, što odgovara 2 mg cisatrakurija |
Pharmaceutical Form |
Otopina za injekciju / infuziju |
Manufacturer |
B. Braun Medical S.A., Jaen, Španjolska |
Marketing Authorisation Holder |
Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
Marketing Authorisation Date |
12.03.2020 |
MA Period of Validity |
12.03.2025 |
Classification Number |
UP/I-530-09/19-01/189 |
Registration Number |
381-12-01/30-20-04 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
M03AC11 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |