Klozapin Accord 100 mg tablete
Name | Klozapin Accord 100 mg tablete |
---|---|
Marketing Authorisation Number | HR-H-976848674 |
Active Substance | klozapin |
Composition | svaka tableta sadrži 100 mg klozapina |
Pharmaceutical Form | tableta |
Manufacturer | Laboratori Fundacio Dau, Barcelona, Španjolska
Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska Accord Healthcare B.V., Utrecht, Nizozemska Accord Healthcare Single Member S.A., Lamia, Tanagra Viotia , Grčka |
Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
Marketing Authorisation Date | 10.07.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/21-02/55 |
Registration Number | 381-12-01/154-23-04 |
Prescription | Medicinal product subject to medical prescription |
Type of prescription | ograničeni recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | N05AH02 |
Marketing status | stavljeno u promet |
Shortage status | nema nestašice |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |