CoAprovel
The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.
| Name | CoAprovel |
|---|---|
| Active Substance | irbesartan hidroklorotiazid |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept (tableta, filmom obložena tableta) |
| Distribution | Supply through pharmacies (community) |
| ATC Code | C09DA04 |
| Marketing status | nije stavljeno u promet |
| Summary of product characteristics (SmPC), labelling and package leaflet (PL) | download |
| Link to the European Medicines Agency's (EMA) product information | download |
| Link to the European Commission's (EC) decisions | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku od nemelanomskog raka kože povezanog s primjenom hidroklorotiazida | 17.10.2018 | Alkaloid, Belupo, Berlin-Chemie Menarini, Boehringer Ingelheim International, Farmal, Genericon, Pharma, Jadran Galenski laboratorij, Krka - farma, Merck, Merck Sharp & Dohme, Novartis, PharmaSwiss, Pliva, Sandoz, sanofi-aventis i Stada |
