Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Dovato 50 mg/300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Oval, biconvex, white, film coated tablet, approximately 18.5 × 9.5 mm, debossed with “SV 137” on one face. |
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine.
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. |
|
| Lamivudine |
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription. |
|
| Lamivudine and Dolutegravir |
Lamivudine and dolutegravir combination is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents. Dolutegravir inhibits HIV integrase and lamivudine, via its active metabolite 5'-triphosphates (TP) (an analogue for cytidine), inhibits reverse transcriptase of HIV-1 and HIV-2. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Tablet coating: Hypromellose (E464) |
Bottle pack:
Opaque, white HDPE (high density polyethylene) bottles closed with child-resistant polypropylene closures, with a polyethylene faced induction heat seal liner. Each pack consists of one bottle containing 30 filmcoated tablets.
Multipacks containing 90 (3 bottle packs of 30) film-coated tablets.
Blister pack:
Blister strips comprising poly(chlorotrifluoroethylene) (PCTFE), both sides laminated with a Polyvinyl Chloride (PVC) film, sealed with child-resistant push through aluminium lidding foil using a heat seal lacquer. Each 30 film-coated tablets blister pack consists of four blister strips containing 7 film-coated tablets and one blister strip containing 2 film-coated tablets.
Multipacks containing 90 (3 blister packs of 30) film-coated tablets.
Not all pack sizes may be marketed.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
EU/1/19/1370/001
EU/1/19/1370/002
EU/1/19/1370/003
EU/1/19/1370/004
Date of first authorization: 1st July 2019
| Drug | Countries | |
|---|---|---|
| DOVATO | Austria, Australia, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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