Monopril plus 20 mg/12,5 mg tablete
| Name | Monopril plus 20 mg/12,5 mg tablete |
|---|---|
| Former Name | Monotens plus 20/12,5 mg tablete |
| Marketing Authorisation Number | HR-H-525879292 |
| Active Substance | fosinoprilnatrij hidroklorotiazid |
| Composition | 1 tableta sadrži 20 mg fosinoprilnatrija i 12,5 mg hidroklorotiazida |
| Pharmaceutical Form | tableta |
| Manufacturer | PharmaSwiss d.o.o., Trzin, Slovenija Bausch Health Poland sp. z o.o., Rzeszow, Poljska |
| Marketing Authorisation Holder | Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Irska |
| Marketing Authorisation Date | 23.06.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/14-02/136 |
| Registration Number | 381-12-01/70-20-61 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C09BA09 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| SmPC | download |
| PL | 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 |
