Name |
Espumisan forte 240 mg meke kapsule |
Marketing Authorisation Number |
HR-H-371804176 |
Active Substance |
simetikon |
Composition |
jedna kapsula sadrži 240 mg simetikona |
Pharmaceutical Form |
Kapsula, meka |
Manufacturer |
Laboratorios Alcalá Farma S.L., Alcala de Henares, Madrid, Španjolska |
Marketing Authorisation Holder |
Berlin-Chemie AG, Glienicker Weg 125, Berlin, Njemačka |
Marketing Authorisation Date |
13.05.2025 |
MA Period of Validity |
26.06.2029 |
Classification Number |
UP/I-530-09/23-01/155 |
Registration Number |
381-12-01/286-25-17 |
Prescription |
Medicinal product not subject to medical prescription |
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
allowed |
ATC Code |
A03AX13 |
Marketing status |
nije stavljeno u promet |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |