Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Rukobia 600 mg prolonged-release tablets.
| Pharmaceutical Form |
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Prolonged-release tablet. Beige, film-coated, biconvex, oval tablets approximately 19 mm in length, 10 mm in width, and 8 mm in thickness and debossed with ‘SV 1V7’ on one side. |
Each prolonged-release tablet contains fostemsavir tromethamine equivalent to 600 mg fostemsavir.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Fostemsavir is a prodrug without significant antiviral activity that is hydrolysed to the active moiety, temsavir, upon cleavage of a phosphonooxymethyl group in vivo. Temsavir binds directly to the gp120 subunit within the HIV-1 envelope glycoprotein gp160 and selectively inhibits the interaction between the virus and cellular CD4 receptor, thereby preventing viral entry into, and infection of, host cells. |
| List of Excipients |
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Tablet core: Hydroxypropylcellulose Tablet coating: Poly(vinyl alcohol) |
White high density polyethylene (HDPE) bottles with polypropylene child resistant closures that include a polyethylene faced induction heat seal liner. Each pack consists of one or three bottles, each containing 60 prolonged-release tablets.
Not all pack sizes may be marketed.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
EU/1/20/1518/001
EU/1/20/1518/002
Date of first authorisation: 04 February 2021
| Drug | Countries | |
|---|---|---|
| RUKOBIA | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United States |
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