This brand name is authorized in Austria, Canada, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa
The drug DELSTRIGO contains a combination of these active pharmaceutical ingredients (APIs):
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1
Doravirine
UNII 913P6LK81M - DORAVIRINE
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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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2
Tenofovir disoproxil
UNII OTT9J7900I - TENOFOVIR DISOPROXIL FUMARATE
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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. |
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3
Lamivudine
UNII 2T8Q726O95 - LAMIVUDINE
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| DELSTRIGO Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| J05AR24 | J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AR Antivirals for treatment of HIV infections, combinations | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: CA | Health Products and Food Branch | Identifier(s): 02482592 |
| Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 5520-MEE-1020 |
| Country: EE | Ravimiamet | Identifier(s): 1782930, 1782941 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 073928 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 64419961 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 368778 |
| Country: HK | Department of Health Drug Office | Identifier(s): 66557 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8504 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1086626, 1086627 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 198684 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100416690 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W65375001, W65375002 |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699636091524 |
| Country: US | FDA, National Drug Code | Identifier(s): 0006-5007 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): 53/20.2.8/0233 |
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