Omacor 1000 mg meke kapsule
| Name | Omacor 1000 mg meke kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-239310133 |
| 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%) |
| 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 | 04.05.2016 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/14-02/411 |
| Registration Number | 381-12-01/70-16-12 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C10AX06 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
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. |
