Medicinal Products
Dutasterid Genericon 0,5 mg meke kapsule
| Name |
Dutasterid Genericon 0,5 mg meke kapsule |
| Marketing Authorisation Number |
HR-H-632191824 |
| Active Substance |
dutasterid |
| Composition |
jedna kapsula sadrži 0,5 mg dutasterida |
| Pharmaceutical Form |
kapsula, meka |
| Manufacturer |
Laboratorios Leon Farma S.A., Villaquialambre, Leon, Španjolska |
| Marketing Authorisation Holder |
Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, Austrija |
| Marketing Authorisation Date |
25.01.2024 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/22-02/96 |
| Registration Number |
381-12-01/70-24-04 |
| 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 |
G04CB02 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
Packaging
| Packaging description |
MA Number for Packaging |
Marketing status |
Shortage status |
| 10 kapsula u blisteru, u kutiji |
HR-H-632191824-01 |
- |
- |
| 30 kapsula u blisteru, u kutiji |
HR-H-632191824-02 |
stavljeno u promet |
nema nestašice |
| 50 kapsula u blisteru, u kutiji |
HR-H-632191824-03 |
- |
- |
| 60 kapsula u blisteru, u kutiji |
HR-H-632191824-04 |
nije stavljeno u promet |
- |
| 90 kapsula u blisteru, u kutiji |
HR-H-632191824-05 |
- |
- |
Direct Healthcare Professional Communication
| Name |
Date |
Download |
| Pismo zdravstvenim radnicima o mjerama za smanjenje rizika od suicidalnih misli povezanih s primjenom lijekova koji sadrže dutasterid i finasterid |
09.09.2025 |
Zentiva, Viatris Hrvatska, Krka-farma, Genericon Pharma, Alpha-Medical, Belupo lijekovi i kozmetika, PharmaS, Galenika Adria, Pharmakos Consulting, Alkaloid, PLIVA Hrvatska, MIP Pharma Croatia, Organon Pharma |
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