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VOCABRIA Prolonged-release suspension for injection (2021)

Active ingredients: Cabotegravir

Product Name and Form

400 mg: Vocabria 400 mg prolonged-release suspension for injection.

600 mg: Vocabria 600 mg prolonged-release suspension for injection.

Pharmaceutical form

Prolonged-release suspension for injection.

White to light pink suspension.

Qualitative and Quantitative Composition

400 mg: Each vial contains 400 mg cabotegravir in 2 mL.

600 mg: Each vial contains 600 mg cabotegravir in 3 mL.

For the full list of excipients, see section 6.1.

Chemical substance
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

400 mg (2 mL vial)

Brown 2 mL type I glass vial, with bromobutyl rubber stopper and a grey aluminium overseal with a dark grey plastic flip-cap.

Each pack contains: 1 vial (400 mg), 1 graduated syringe (sterile, single use with volumetric markings every 0.2 mL), 1 vial adaptor and 1 injection needle (0.65 mm, 38 mm [23 gauge, 1½ inch]).

600 mg (3mL vial)

Brown 3 mL type I glass vial, with bromobutyl rubber stopper and a grey aluminium overseal with an orange plastic flip-cap. 600 mg (3 mL) pack

Each pack contains: 1 vial (600 mg), 1 graduated syringe (sterile, single use with volumetric markings every 0.2 mL), 1 vial adaptor and 1 injection needle (0.65 mm, 38 mm [23 gauge, 1½ inch]).

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

EU/1/20/1481/002
EU/1/20/1481/003