Švedska grenčica Riviera oralna otopina
| Name | Švedska grenčica Riviera oralna otopina |
|---|---|
| Marketing Authorisation Number | HR-H-239663734 |
| Active Substance | Tekući ekstrakt iz mješavine biljnih droga pelinova zelen, korijen žutog srčanika, korijen ljekovite anđelike, mira, maslačkov korijen, podanak bijele kurkume, orahov list, iđirotov podanak, podanak uspravne petoprste, maruljina zelen, odoljenov korijen, kora cejlonskog cimetovca i kardamomov plod ekstrakcijsko otapalo: etanol 48% V/V |
| Composition | 100 ml oralne otopine sadrži 71,5 ml ekstrakta (kao tekući ekstrakt) (odgovara količini od 2,01 g mješavine biljnih droga) iz Artemisia absinthium L., herba (pelinova zelen), Gentiana lutea L., radix (korijen žutog srčanika), Angelica archangelica L., radix (korijen ljekovite anđelike), Commiphora molmol Engler, gummi-resina (mira), Taraxacum officinale Weber ex Wigg., radix (maslačkov korijen), Curcuma zedoaria (Christm.) Roscoe, rhizoma (podanak bijele kurkume), Juglans regia L., folium (orahov list), Acorus calamus L., rhizoma (iđirotov podanak), Potentilla erecta (L.) Raeusch., rhizoma (podanak uspravne petoprste), Marubium vulgare L., herba (maruljina zelen), Valeriana officinalis L., radix (odoljenov korijen), Cinnamomum verum J.S. Presl, cortex (kora cejlonskog cimetovca), Elettaria cardamomum (L.) Maton, fructus (kardamomov plod). (66/180/328/367/260/294/260/38/50/32/54/54/27 mg) Ekstrakcijsko otapalo: etanol 96,3 % V/V : voda (1:1). DER 1: 33-37. |
| Pharmaceutical Form | oralna otopina |
| Manufacturer | Riviera Pharma & Cosmetics GmbH, Tulln, Austrija |
| Marketing Authorisation Holder | Riviera Pharma & Cosmetics GmbH, Holzhackerstrasse 1, Tulln, Austrija |
| Marketing Authorisation Date | 17.05.2023 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 16.06.2025* |
| Classification Number | UP/I-530-09/22-02/43 |
| Registration Number | 381-12-01/70-23-07 |
| Prescription | Medicinal product not subject to medical prescription |
| Distribution | Supply through pharmacies (community) and non-pharmacy outlets |
| Advertising to general public | allowed |
| ATC Code | A09 |
| Marketing status | trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
