Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
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. |
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 Film-coating: Lactose monohydrate The tablet may also contain trace amount of carnauba wax. |
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.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/07/436/006
EU/1/07/436/007
Date of first authorisation: 20 December 2007
Date of latest renewal: 14 May 2014
| Drug | Countries | |
|---|---|---|
| ISENTRESS | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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