ISENTRESS Film-coated tablet Ref.[8806] Active ingredients: Raltegravir

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Product name and form

ISENTRESS 600 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, oval-shaped, dimensions 19.1 mm x 9.7 mm x 6.1 mm, marked with MSD corporate logo and “242” on one side and plain on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 600 mg of raltegravir (as potassium).

Excipient with known effect: Each 600 mg tablet contains 5.72 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Raltegravir

Raltegravir is an integrase strand transfer inhibitor active against the Human Immunodeficiency Virus (HIV-1). Raltegravir inhibits the catalytic activity of integrase, an HIV-encoded enzyme that is required for viral replication. Inhibition of integrase prevents the covalent insertion, or integration, of the HIV genome into the host cell genome.

List of Excipients

Tablet core:

Microcrystalline cellulose
Hypromellose 2910
Magnesium stearate
Croscarmellose sodium

Film-coating:

Lactose monohydrate
Hypromellose 2910
Titanium dioxide
Triacetin
Iron oxide yellow
Black iron oxide

The tablet may also contain trace amount of carnauba wax.

Pack sizes and marketing

High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure, induction seal and silica gel dessicant.

Two pack sizes are available: 1 bottle with 60 tablets, and a multipack containing 180 (3 bottles of 60) tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/07/436/006
EU/1/07/436/007

Date of first authorisation: 20 December 2007
Date of latest renewal: 14 May 2014

Drugs

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

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