Corprotect 1000 mg meke kapsule
| Name | Corprotect 1000 mg meke kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-609261265 |
| Active Substance | etilni[90]esteri omega-3 kiselina |
| Composition | jedna kapsula sadrži 1000 mg etilnih[90]estera omega-3 kiselina, s udjelom etilnih estera eikosapentaenoatne kiseline (EPA) od 460 mg i etilnih estera dokosaheksaenoatne kiseline (DHA) od 380 mg (ukupno 840 mg EPA i DHA) |
| Pharmaceutical Form | kapsula, meka |
| Packaging [MA Number for Packaging] | 30 kapsula u bočici, u kutiji [HR-H-609261265-05] 90 kapsula u bočici, u kutiji [HR-H-609261265-06] 30 kapsula u blisteru, u kutiji [HR-H-609261265-01] 60 kapsula u blisteru, u kutiji [HR-H-609261265-02] 90 kapsula u blisteru, u kutiji [HR-H-609261265-03] 120 kapsula u blisteru, u kutiji [HR-H-609261265-04] |
| Manufacturer | Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Teva Pharmaceutical Works Private Limited Company, Debrecen, Mađarska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 28.06.2017 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 05.06.2023* |
| Classification Number | UP/I-530-09/16-02/309 |
| Registration Number | 381-12-01/30-17-05 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C10AX06 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
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. |
