EFRIN Film-coated tablet Ref.[51182] Active ingredients: Efavirenz

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Viatris Healthcare (Pty) Ltd, 4 Brewery Street, Isando, Johannesburg, 1600, Gauteng, South Africa

Product name and form

EFRIN (film-coated tablet).

Pharmaceutical Form

Peach coloured, capsule shaped, film-coated tablets, debossed with “M109” on one side and plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 600 mg efavirenz.

Contains sugar: Lactose monohydrate 255, 60 mg.

Active Ingredient Description
Efavirenz

Efavirenz is a NNRTI of HIV-1. Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).

List of Excipients

Cellulose microcrystalline, croscarmellose sodium, hydroxypropyl cellulose, sodium lauryl sulfate, lactose, magnesium stearate, film-coat {hypromellose, titanium dioxide, macrogol/PEG 400, iron oxide yellow, iron oxide red}.

Pack sizes and marketing

EFRIN is packed in high density polypropylene (HDPE) bottle pack (marketable pack) comprising of wide mouth white HDPE bottle with a white opaque polypropylene (PP) closure with induction sealing in pack sizes of 30’s packed in a carton.

Marketing authorization holder

Viatris Healthcare (Pty) Ltd, 4 Brewery Street, Isando, Johannesburg, 1600, Gauteng, South Africa

Marketing authorization dates and numbers

45/20.2.8/0169

20 April 2012

Drugs

Drug Countries
EFRIN South Africa

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