Hidrasec 10 mg granule za oralnu suspenziju
Name | Hidrasec 10 mg granule za oralnu suspenziju |
---|---|
Marketing Authorisation Number | HR-H-944929327 |
Active Substance | racekadotril |
Composition | jedna vrećica sadrži 10 mg racekadotrila |
Pharmaceutical Form | granule za oralnu suspenziju |
Packaging [MA Number for Packaging] | 16 vrećica s granulama, u kutiji [HR-H-944929327-01] 20 vrećica s granulama, u kutiji [HR-H-944929327-02] |
Manufacturer | Sophartex, Vernouillet, Francuska |
Marketing Authorisation Holder | Bioprojet Pharma, 9, rue rameau, Paris, Francuska |
Marketing Authorisation Date | 05.06.2018 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/16-02/404 |
Registration Number | 381-12-01/30-18-13 |
Prescription | na recept |
Type of prescription | neponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | A07XA04 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |