Nebilet Plus 5 mg/25 mg filmom obložene tablete
| Name | Nebilet Plus 5 mg/25 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-340964911 |
| Active Substance | nebivololklorid hidroklorotiazid |
| Composition | jedna tableta Nebileta Plus 5 mg / 25 mg sadrži 5 mg nebivolola (u obliku nebivololklorida: 2,5 mg SRRR-nebivolola ili d-nebivolola i 2,5 mg RSSS-nebivolola ili l-nebivolola) i 25 mg hidroklorotiazida |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Berlin-Chemie AG, Berlin, Njemačka
Menarini-Von Heyden GmbH, Dresden, Njemačka A. Menarini Manufacturing Logistics And Services S.r.l., Firenca, Italija |
| Marketing Authorisation Holder | Berlin-Chemie Menarini Hrvatska d.o.o., Horvatova 80a, Zagreb, Hrvatska |
| Marketing Authorisation Date | 31.08.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/343 |
| Registration Number | 381-12-01/14-17-05 |
| 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 | C07BB12 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| 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 |
