Name |
Utrogestan 300 mg meke kapsule za rodnicu |
Marketing Authorisation Number |
HR-H-677297904 |
Active Substance |
progesteron |
Composition |
jedna kapsula sadrži 300 mg progesterona (mikroniziranog) |
Pharmaceutical Form |
kapsula za rodnicu, meka |
Manufacturer |
Cyndea Pharma S.L., Olvega, Soria, Španjolska |
Marketing Authorisation Holder |
Besins Healthcare Ireland Limited, Plaza 4, Level 4 Custom House Plaza, Harbourmaster Place, International Financial Services Centre, Dublin 1, Irska |
Marketing Authorisation Date |
21.01.2025 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/24-02/91 |
Registration Number |
381-12-01/171-25-05 |
Prescription |
Medicinal product subject to medical prescription |
Type of prescription |
ograničeni recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
G03DA04 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |