Bekunis instant biljni čaj
| Name | Bekunis instant biljni čaj |
|---|---|
| Marketing Authorisation Number | HR-H-893482659 |
| Active Substance | normirani suhi ekstrakt seninog ploda (4,5-5,5:1), prilagođeno na 10 mg hidroksiantracenskih glikozida, izračunato kao senozid B ekstrakcijsko otapalo: voda |
| Composition | 325 mg instant biljnog čaja (1 mjerna žličica) sadrži 100-166,5 mg ekstrakta (kao suhi ekstrakt, normirani) iz Senna alexandrina Mill. (sin. Cassia acutifolia Delile i Cassia angustifolia Vahl), fructus (senin plod) (4,5 - 5,5:1) što odgovara 10 mg hidroksiantracenskih glikozida, izračunato kao senozid B; ekstrakcijsko otapalo: voda |
| Pharmaceutical Form | instant biljni čaj |
| Manufacturer | roha arzneimittel GmbH, Bremen, Njemačka |
| Marketing Authorisation Holder | roha arzneimittel GmbH, Rockwinkeler Heerstraße 100, Bremen, Njemačka |
| Marketing Authorisation Date | 14.11.2016 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 25.04.2023* |
| Classification Number | UP/I-530-09/15-02/280 |
| Registration Number | 381-12-01/38-16-08 |
| Prescription | bez recepta |
| Distribution | u ljekarni i specijaliziranim prodavaonicama za promet na malo lijekovima |
| Advertising to general public | dopušteno |
| ATC Code | A06AB06 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
