Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
REKAMBYS 600 mg prolonged-release suspension for injection.
REKAMBYS 900 mg prolonged-release suspension for injection.
| Pharmaceutical Form |
|---|
|
Prolonged-release suspension for injection. White to off-white suspension. |
2 mL vial: Each vial contains 600 mg rilpivirine.
3 mL vial: Each vial contains 900 mg rilpivirine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rilpivirine |
Rilpivirine is a diarylpyrimidine NNRTI of HIV-1. Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ. |
| List of Excipients |
|---|
|
Poloxamer 338 |
Type I glass vial.
600 mg pack: Each pack contains one clear 4-mL glass vial, with a butyl elastomer stopper and an aluminium overseal with a plastic flip-off button, 1 syringe (0.2 mL graduation), 1 vial adaptor and 1 needle for injection (23 gauge, 1½ inch).
900 mg pack: Each pack contains one clear 4-mL glass vial, with a butyl elastomer stopper and an aluminium overseal with a plastic flip-off button, 1 syringe (0.2 mL graduation), 1 vial adaptor and 1 needle for injection (23 gauge, 1½ inch).
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
600 mg: EU/1/20/1482/001
900 mg: EU/1/20/1482/002
Date of first authorisation: 17 December 2020
| Drug | Countries | |
|---|---|---|
| REKAMBYS | Austria, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, United Kingdom |
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