Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Tivicay 5 mg dispersible tablets.
| Pharmaceutical Form |
|---|
|
Dispersible tablet. White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV H7S’ on one side and ‘5’ on the other side. |
Each dispersible tablet contains dolutegravir sodium equivalent to 5 mg dolutegravir.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dolutegravir |
Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral Deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. |
| List of Excipients |
|---|
|
Tablet core: Mannitol (E421) Tablet coating: Titanium dioxide (E171) |
HDPE (high density polyethylene) bottles closed with child resistant polypropylene screw closures, with a polyethylene faced induction heat seal liner. The bottles contain 60 dispersible tablets and a desiccant.
A dosing cup and oral syringe, both made from polypropylene with graduation marks, are supplied with the pack. The syringe’s plunger is made from HDPE.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
EU/1/13/892/007
Date of first authorisation: 16 January 2014
Date of latest renewal: 21 September 2018
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
