Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
CRIXIVAN 400 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. The capsules are semi-translucent white and coded ‘CRIXIVAN 400 mg’ in green. |
Each hard capsule contains indinavir sulphate corresponding to 400 mg of indinavir.
Excipient with known effect: Each 400 mg capsule contains 149.6 mg of lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Indinavir |
Indinavir inhibits recombinant HIV-1 and HIV-2 protease with an approximate tenfold selectivity for HIV-1 over HIV-2 proteinase. Indinavir binds reversibly to the protease active site and inhibits competitively the enzyme, thereby preventing cleavage of the viral precursor polyproteins that occurs during maturation of the newly formed viral particle. |
| List of Excipients |
|---|
|
Capsule content: Anhydrous lactose Capsule shell: Gelatin |
HDPE bottles with a polypropylene cap and a foil induction cap containing 90 or 180 capsules.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/96/024/004
EU/1/96/024/005
Date of first authorisation: 04 October 1996
Date of latest renewal: 18 July 2011
| Drug | Countries | |
|---|---|---|
| CRIXIVAN | Austria, Cyprus, Estonia, Lithuania, Poland, Singapore, United States, South Africa |
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