Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Tivicay 10 mg film-coated tablets.
Tivicay 25 mg film-coated tablets.
Tivicay 50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Tivicay 10 mg film-coated tablets: White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV 572’ on one side and ‘10’ on the other side. Tivicay 25 mg film-coated tablets: Pale yellow, round, biconvex tablets approximately 7 mm in diameter debossed with ‘SV 572’ on one side and ‘25’ on the other side. Tivicay 50 mg film-coated tablets: Yellow, round, biconvex tablets approximately 9 mm in diameter debossed with ‘SV 572’ on one side and ‘50’ on the other side. |
Tivicay 10 mg film-coated tablets: Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir.
Tivicay 25 mg film-coated tablets: Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir.
Tivicay 50 mg film-coated tablets: Each film-coated tablet contains dolutegravir sodium equivalent to 50 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: Poly(vinyl alcohol) partially hydrolyzed |
HDPE (high density polyethylene) bottles closed with child resistant polypropylene screw closures, with a polyethylene faced induction heat seal liner. The bottles contain 30 or 90 film-coated tablets.
Tivicay 10 mg film-coated tablets: Each bottle contains a desiccant.
Not all pack sizes may be marketed.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
EU/1/13/892/001
EU/1/13/892/002
EU/1/13/892/003
EU/1/13/892/004
EU/1/13/892/005
EU/1/13/892/006
Date of first authorisation: 16 January 2014
Date of latest renewal: 21 September 2018
| Drug | Countries | |
|---|---|---|
| TIVICAY | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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