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VOCABRIA Film-coated tablet (2021)

Active ingredients: Cabotegravir

Product Name and Form

Vocabria 30 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet (tablet).

White, oval, film-coated tablets (approximately 8.0 mm by 14.3 mm), debossed with ‘SV CTV’ on one side.

Qualitative and Quantitative Composition

Each tablet contains cabotegravir sodium equivalent to 30 mg cabotegravir.

Excipient with known effect: Each film-coated tablet contains 155 mg lactose (as monohydrate).

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

Tablet core:

Lactose monohydrate
Microcrystalline cellulose (E460)
Hypromellose (E464)
Sodium starch glycolate
Magnesium stearate

Tablet coating:

Hypromellose (E464)
Titanium dioxide (E171)
Macrogol (E1521)

Pack sizes and Marketing

White HDPE (high density polyethylene) bottles closed with polypropylene child-resistant closures, with a polyethylene faced induction heat seal liner. Each bottle contains 30 film-coated tablets.

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

EU/1/20/1481/001