INVIRASE Film-coated tablet Ref.[8793] Active ingredients: Saquinavir

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Product name and form

INVIRASE 500 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Light orange to greyish or brownish orange film-coated tablet of oval cylindrical biconvex shape with the marking “SQV 500” on the one side and “ROCHE” on the other side.

Qualitative and quantitative composition

One film-coated tablet contains 500 mg of saquinavir as saquinavir mesilate.

Excipient with known effect: Lactose monohydrate: 38.5 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Saquinavir

Saquinavir selectively inhibits the HIV protease, thereby preventing the creation of mature infectious virus particles. The HIV protease is an essential viral enzyme required for the specific cleavage of viral gag and gag-pol polyproteins.

List of Excipients

Tablet core:

Microcrystalline cellulose
Croscarmellose sodium
Povidone
Lactose (monohydrate)
Magnesium stearate

Tablet coat:

Hypromellose
Titanium dioxide (E171)
Talc
Glycerol triacetate
Iron oxide yellow and red (E172)

Pack sizes and marketing

Plastic bottles (HDPE) containing 120 tablets.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

EU/1/96/026/002

Date of first authorisation: 04 October 1996
Date of latest renewal: 04 October 2006

Drugs

Drug Countries
INVIRASE Austria, Australia, Cyprus, Estonia, Hong Kong, Ireland, Lithuania, Netherlands, Poland, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.