Emtricitabin/tenofovirdizoproksil Pliva 200 mg/245 mg filmom obložene tablete
| Name | Emtricitabin/tenofovirdizoproksil Pliva 200 mg/245 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-663403629 |
| Active Substance | emtricitabin tenofovirdizoproksil fosfat |
| Composition | jedna filmom obložena tableta sadrži 200 mg emtricitabina i 245 mg tenofovirdizoproksila (što odgovara 291,22 mg tenofovirdizoproksilfosfata ili 136 mg tenofovira) |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Pliva Hrvatska d.o.o., Zagreb, Hrvatska Teva Operations Poland Sp. z o.o., Krakow, Poljska Merckle GmbH, Blaubeuren, Njemačka |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 19.10.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/20-02/88 |
| Registration Number | 381-12-01/38-20-03 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J05AR03 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Kontrolni popis za lijecnike, verzija 2 Važne sigurnosne informacije za liječnike (PrEP), verzija 3 Vodič za zdravstvene radnike za liječenje HIV 1 infekcije u djece, verzija 4 |
| Educational materials for patients / caregivers |
Vodič za bolesnike, verzija 2 Podsjetnik za bolesnike, verzija 2 |
