Nutriflex Omega 38/120 plus emulzija za infuziju
| Name | Nutriflex Omega 38/120 plus emulzija za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-668065794 |
| Active Substance | glukoza hidrat natrijev dihidrogenfosfat dihidrat cinkov acetat dihidrat trigliceridi, srednje duljine lanca sojino ulje, rafinirano trigliceridi omega-3 kiseline izoleucin leucin lizinklorid metionin fenilalanin treonin triptofan valin arginin histidinklorid hidrat alanin aspartatna kiselina glutamatna kiselina glicin prolin serin natrijev hidroksid natrijev klorid natrijev acetat trihidrat kalijev acetat magnezijev acetat tetrahidrat kalcijev klorid dihidrat |
| Composition | 1250 ml sadrži 500 ml otopine aminokiselina + 250 ml emulzije masti + 500 ml otopine glukoze 1875 ml sadrži 750 ml otopine aminokiselina + 375 ml emulzije masti + 750 ml otopine glukoze 2500 ml sadrži 1000 ml otopine aminokiselina + 500 ml emulzije masti + 1000 ml otopine glukoze |
| Pharmaceutical Form | emulzija za infuziju |
| Manufacturer | B. Braun Melsungen AG, Melsungen, Njemačka |
| Marketing Authorisation Holder | B. Braun Melsungen AG, Carl-Braun-Str. 1, Melsungen, Njemačka |
| Marketing Authorisation Date | 11.01.2024 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 19.01.2024* |
| Classification Number | UP/I-530-09/20-02/116 |
| Registration Number | 381-12-01/70-24-11 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B05BA10 |
| Medicinal product marketed in the Croatia | Da |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
