Duster Duo 0,5 mg/0,4 mg tvrde kapsule
Name | Duster Duo 0,5 mg/0,4 mg tvrde kapsule |
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Marketing Authorisation Number | HR-H-875149769 |
Active Substance | dutasterid tamsulozinklorid |
Composition | svaka tvrda kapsula sadrži 0,5 mg dutasterida i 0,4 mg tamsulozinklorida (ekvivalentno 0,367 mg tamsulozina) |
Pharmaceutical Form | kapsula, tvrda |
Packaging [MA Number for Packaging] | 7 kapsula u bočici, u kutiji [HR-H-875149769-01] 30 kapsula u bočici, u kutiji [HR-H-875149769-02] 90 kapsula u bočici, u kutiji [HR-H-875149769-03] 180 kapsula (2 bočice od 90 kapsula), u kutiji [HR-H-875149769-04] |
Manufacturer | Laboratorios Leon Farma S.A., Villaquialambre, Leon, Španjolska |
Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
Marketing Authorisation Date | 14.02.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/22-02/175 |
Registration Number | 381-12-01/171-23-04 |
Prescription | na recept |
Type of prescription | ponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | G04CA52 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |