| Name |
Cisatrakurij Accordpharma 5 mg/ml otopina za injekciju/infuziju |
| Marketing Authorisation Number |
HR-H-400799381 |
| Active Substance |
cisatrakurijev besilat |
| Composition |
1 ml otopine za injekciju ili infuziju sadrži 6,70 mg cisatrakurij besilata, što odgovara 5 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 |
16.04.2025 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/24-02/45 |
| Registration Number |
381-12-01/70-25-08 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
M03AC11 |
| Marketing status |
Marketed |
| Shortage status |
Actual |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
