Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
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. |
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.
| 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) |
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]).
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Date of first authorisation: 17 December 2020
| Drug | Countries | |
|---|---|---|
| VOCABRIA | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United States |
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