EDURANT Film-coated tablet Ref.[8790] Active ingredients: Rilpivirine

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

EDURANT 25 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to off-white, round, biconvex, film-coated tablet with a diameter of 6.4 mm, debossed with “TMC” on one side and “25” on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.

Excipient with known effect: Each film-coated tablet contains 56 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rilpivirine

Rilpivirine is a diarylpyrimidine NNRTI of HIV-1. Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
List of Excipients

Tablet core:

Lactose monohydrate
Croscarmellose sodium
Povidone K30
Polysorbate 20
Silicified microcrystalline cellulose
Magnesium stearate

Tablet coating:

Lactose monohydrate
Hypromellose 2910 6 mPa.s
Titanium dioxide E171
Macrogol 3000
Triacetin

Pack sizes and marketing

75 ml high density polyethylene (HDPE) bottle with a polypropylene (PP) child resistant closure and induction seal liner. Each carton contains one bottle of 30 tablets.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization dates and numbers

EU/1/11/736/001

Date of first authorisation: 28 November 2011
Date of latest renewal: 22 July 2016

Drugs

Drug Countries
EDURANT Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa
 
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