Dutamera 0,5 mg/0,4 mg tvrde kapsule
Name | Dutamera 0,5 mg/0,4 mg tvrde kapsule |
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Marketing Authorisation Number | HR-H-894517516 |
Active Substance | dutasterid tamsulozinklorid |
Composition | svaka tvrda kapsula sadrži 0,5 mg dutasterida i 0,4 mg tamsulozinklorida (što odgovara 0,367 mg tamsulozina) |
Pharmaceutical Form | Kapsula, tvrda |
Manufacturer | Laboratorios Leon Farma S.A., Villaquialambre, Leon, Španjolska |
Marketing Authorisation Holder | Galenika International Kft., Baross utca 165/3, Budaörs, Mađarska |
Marketing Authorisation Date | 24.01.2025 |
MA Period of Validity | 24.01.2030 |
Classification Number | UP/I-530-09/23-01/107 |
Registration Number | 381-12-01/70-25-10 |
Prescription | Medicinal product subject to medical prescription |
Type of prescription | ponovljivi recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | G04CA52 |
Marketing status | nije stavljeno u promet |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |