APRETUDE Prolonged-release suspension for injection Ref.[51260] Active ingredients: Cabotegravir

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Product name and form

Apretude 600 mg prolonged-release suspension for injection.

Pharmaceutical Form

Prolonged-release suspension for injection.

White to light pink suspension.

Qualitative and quantitative composition

Each vial contains 600 mg cabotegravir in 3 mL.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cabotegravir

Cabotegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.

List of Excipients

Mannitol (E421)
Polysorbate 20 (E432)
Macrogol (E1521)
Water for injections

Pack sizes and marketing

Brown 3 mL type I glass vial, with bromobutyl rubber stopper and a grey aluminium overseal with an orange plastic flip-cap.

Pack sizes of 1 vial or 25 vials. Not all pack sizes may be marketed.

Marketing authorization holder

ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Marketing authorization dates and numbers

EU/1/23/1760/002
EU/1/23/1760/003

Drugs

Drug Countries
APRETUDE Estonia, France, Croatia, Ireland, Italy, Lithuania, 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.