Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Delstrigo 100 mg/300 mg/245 mg film-coated tablets.
Pharmaceutical Form |
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Film-coated tablet. Yellow, oval-shaped, tablet of dimensions 21.59 mm x 11.30 mm, debossed with the corporate logo and 776 on one side and plain on the other side. |
Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine (3TC), and 245 mg of tenofovir disoproxil as tenofovir disoproxil fumarate (TDF).
Excipient with known effect: Each film-coated tablet contains 8.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
Active Ingredient | Description | |
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Doravirine |
Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Doravirine does not inhibit the human cellular DNA polymerases α, β, and mitochondrial DNA polymerase γ. |
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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. |
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Lamivudine, Tenofovir disoproxil and Doravirine |
Lamivudine is a nucleoside analogue. Intracellularly, lamivudine is phosphorylated to its active 5'-triphosphate metabolite, lamivudine triphosphate (3TC-TP). The principal mode of action of 3TC-TP is inhibition of HIV-1 reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue. Tenofovir diphosphate inhibits the activity of HIV-1 RT by competing with the natural substrate deoxyadenosine 5'-triphosphate and, after incorporation into DNA, by DNA chain termination. Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 RT. |
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Tenofovir disoproxil |
Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. |
List of Excipients |
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Tablet core: Croscarmellose sodium (E468) Film-coating: Carnauba wax (E903) |
Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccants.
The following pack sizes are available:
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/18/1333/001
EU/1/18/1333/002
Date of first authorisation: 22 November 2018
Drug | Countries | |
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DELSTRIGO | Austria, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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