Pirfenidon Accord 801 mg filmom obložene tablete
| Name | Pirfenidon Accord 801 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-273589108 |
| Active Substance | pirfenidon |
| Composition | jedna filmom obložena tableta sadrži 801 mg pirfenidona |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska
Pharmadox Healthcare Limited, Paola, Malta Accord Healthcare B.V., Utrecht, Nizozemska Laboratori Fundacio Dau, Barcelona, Španjolska |
| Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date | 16.06.2023 |
| MA Period of Validity | 16.06.2028 |
| Classification Number | UP/I-530-09/22-01/193 |
| Registration Number | 381-12-01/154-23-05 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L04AX05 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
