Nitrazepam Accord 5 mg tablete
Name | Nitrazepam Accord 5 mg tablete |
---|---|
Former Name | Nitrazepam PharmaS 5 mg tablete |
Marketing Authorisation Number | HR-H-901745783 |
Active Substance | nitrazepam |
Composition | 1 tableta sadrži 5 mg nitrazepama |
Pharmaceutical Form | Tableta |
Manufacturer | Accord Healthcare Polska Sp. z o.o., Varšava, Poljska PharmaS d.o.o., Zagreb, Hrvatska Wessling Hungary Kft., Budmipešta, Mađarska |
Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
Marketing Authorisation Date | 12.11.2021 |
MA Period of Validity | 04.05.2026 |
Classification Number | UP/I-530-09/19-01/157 |
Registration Number | 381-12-01/70-21-23 |
Prescription | na recept |
Type of prescription | neponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | N05CD02 |
SmPC | download |
PL | download |
Public Assessment Report | download |