Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
REZOLSTA 800 mg/150 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Pink oval shaped tablet of 23 mm x 11.5 mm, debossed with “800” on one side and “TG” on the other side. |
Each film-coated tablet contains 800 mg of darunavir (as ethanolate) and 150 mg of cobicistat.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Cobicistat |
Cobicistat is a mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily. Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as darunavir, where bioavailability is limited and half-life is shortened due to CYP3A-dependent metabolism. |
|
| Darunavir |
Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 × 10-12 M). It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles. |
|
| Darunavir and Cobicistat |
Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease. It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles. Cobicistat is a mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily. Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as darunavir, where bioavailability is limited and half-life is shortened due to CYP3A-dependent metabolism. |
| List of Excipients |
|---|
|
Tablet core: Hypromellose Tablet film-coat: Polyvinyl alcohol–partially hydrolysed |
White, high density polyethylene (HDPE) bottle containing 30 tablets, fitted with polypropylene (PP) child resistant closure with induction seal.
Pack size of one bottle.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/14/967/001
Date of first authorisation: 19 November 2014
Date of latest renewal: 31 July 2019
| Drug | Countries | |
|---|---|---|
| REZOLSTA | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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