Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Pink capsule-shaped, biconvex, beveled-edge film-coated tablet, approximately 21 mm x 11 mm and debossed with ‘M’ on one side and ‘TME’ on the other side. |
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (as maleate).
Excipient with known effect: Each film-coated tablet contains 7.5 mg of sodium metabisulfite and 105.5 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Emtricitabine, Tenofovir disoproxil and Efavirenz |
Efavirenz is an NNRTI of HIV-1. Efavirenz non-competitively inhibits HIV-1 reverse transcriptase (RT) and does not significantly inhibit human immunodeficiency virus-2 (HIV-2) RT or cellular deoxyribonucleic acid (DNA) polymerases (α, β, γ, and δ). Emtricitabine is a nucleoside analogue of cytidine. Tenofovir disoproxil is converted in vivo to tenofovir, a nucleoside monophosphate (nucleotide) analogue of adenosine monophosphate. Emtricitabine and tenofovir are phosphorylated by cellular enzymes to form emtricitabine triphosphate and tenofovir diphosphate, respectively, which competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination. |
| List of Excipients |
|---|
|
Tablet core: Croscarmellose sodium Film-coating: Iron oxide yellow (E172) |
HDPE bottle with PP screw cap or PP child-resistant screw cap with aluminium liner wad and desiccant labelled ‘DO NOT EAT’.
Pack size: 30, 90 film-coated tablets.
Multipack size: 90 (3 packs of 30) film-coated tablets.
OPA/alu/PE/HDPE/alu blister pack containing 30 and 90 tablets.
OPA/alu/PE/HDPE/alu perforated unit dose blister pack containing 30 × 1, 90 × 1 tablets.
Not all pack sizes may be marketed.
Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
EU/1/17/1222/001
EU/1/17/1222/002
EU/1/17/1222/003
EU/1/17/1222/004
EU/1/17/1222/005
EU/1/17/1222/006
EU/1/17/1222/007
Date of first authorisation: 05 September 2017
Date of latest renewal: 24 May 2022
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