| Name |
Premensdoc filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-870196585 |
| Active Substance |
suhi ekstrakt konopljikinog ploda (6-12:1), ekstrakcijsko otapalo: etanol 60% (m/m) |
| Composition |
jedna filmom obložena tableta sadrži 20 mg ekstrakta (kao suhi ekstrakt) iz Vitex agnus-castus L., fructus (konopljikin plod) (DER 6-12:1); ekstrakcijsko otapalo: etanol 60% (m/m) |
| Pharmaceutical Form |
Filmom obložena tableta |
| Manufacturer |
Drehm Pharma GmbH, Beč, Austrija |
| Marketing Authorisation Holder |
Guterrat Gesundheitsprodukte GmbH & Co KG, Eduard-Bodem-Gasse 6, Amras, Innsbruck, Tirol, Austrija |
| Marketing Authorisation Date |
24.01.2023 |
| MA Period of Validity |
24.01.2028 |
| Classification Number |
UP/I-530-09/22-01/28 |
| Registration Number |
381-12-01/154-23-06 |
| Prescription |
Medicinal product not subject to medical prescription |
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
allowed |
| ATC Code |
G02CX03 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
