Klozapin Accord 25 mg tablete
| Name | Klozapin Accord 25 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-047845273 |
| Active Substance | klozapin |
| Composition | svaka tableta sadrži 25 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-530-09/21-02/54 |
| Registration Number | 381-12-01/154-23-06 |
| 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 | N05AH02 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o revidiranim preporukama za redovito praćenje krvne slike povezano s rizikom od agranulocitoze kod primjene lijekova koji sadrže klozapin | 08.09.2025 | Viatris Hrvatska d.o.o., Accord Healthcare Polska Sp. z o.o./PharmaS d.o.o., Alpha-Medical d.o.o., Makpharm d.o.o. |
