Dualtis 1000 mg meke kapsule
| Name | Dualtis 1000 mg meke kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-550928853 |
| Active Substance | etilni[90]esteri omega-3 kiselina |
| Composition | jedna kapsula sadrži: etilni [90] esteri omega-3 kiselina 1000 mg, koji sadrže 840 mg etilnih estera eikosapentaenoatne kiseline (EPA) (46%) i etilnih estera dokosaheksaenoatne kiseline (DHA) (38%), uključujući 4 mg antioksidansa alfa-tokoferola (pomiješan s biljnim uljem npr. sojinim) |
| Pharmaceutical Form | kapsula, meka |
| Manufacturer | McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Dublin, Irska
Mylan Hungary Kft, Komárom, Mađarska |
| Marketing Authorisation Holder | Viatris Hrvatska d.o.o., Koranska 2, Zagreb, Hrvatska |
| Marketing Authorisation Date | 23.12.2019 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 21.09.2026* |
| Classification Number | UP/I-530-09/17-02/505 |
| Registration Number | 381-12-01/38-19-06 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C10AX06 |
| Marketing status | Not marketed |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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, 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.
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o povišenom riziku od atrijske fibrilacije, ovisnom o dozi lijeka, u bolesnika koji su liječeni lijekovima koji sadrže etilne estere omega-3 kiselina te boluju od kardiovaskularnih bolesti ili imaju kardiovaskularne rizične faktore | 08.11.2023 | Viatris Hrvatska d.o.o., Pliva Hrvatska d.o.o. |
