Aprepitant Sandoz 125 mg + 80 mg tvrde kapsule
Name | Aprepitant Sandoz 125 mg + 80 mg tvrde kapsule |
---|---|
Marketing Authorisation Number | HR-H-208260366 |
Active Substance | aprepitant |
Composition | jedna tvrda kapsula sadrži 125 mg aprepitanta jedna tvrda kapsula sadrži 80 mg aprepitanta |
Pharmaceutical Form | kapsula, tvrda |
Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija Rontis Hellas Medical and Pharmaceutical Products S.A., Larissa, Grčka |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 17.08.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/22-02/39 |
Registration Number | 381-12-01/286-23-08 |
Prescription | Medicinal product subject to medical prescription |
Type of prescription | neponovljivi recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | A04AD12 |
SmPC | download |
PL | download |
Public Assessment Report | download |