BUVIDAL Prolonged-release solution for injection (2019)
Active ingredients: Buprenorphine
Product Name and Form
Buvidal 8 mg prolonged-release solution for injection.
Buvidal 16 mg prolonged-release solution for injection.
Buvidal 24 mg prolonged-release solution for injection.
Buvidal 32 mg prolonged-release solution for injection.
Prolonged-release solution for injection.
Yellowish to yellow clear liquid.
Qualitative and Quantitative Composition
8 mg prolonged-release solution for injection: Each pre-filled syringe contains 8 mg buprenorphine
16 mg prolonged-release solution for injection: Each pre-filled syringe contains 16 mg buprenorphine
24 mg prolonged-release solution for injection: Each pre-filled syringe contains 24 mg buprenorphine
32 mg prolonged-release solution for injection: Each pre-filled syringe contains 32 mg buprenorphine
Excipient(s) with known effect: The 8 mg, 16 mg, 24 mg and 32 mg strengths contain small amounts of ethanol (alcohol), less than 100 mg per dose.
For the full list of excipients, see section 6.1.
Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the μ (mu) and κ (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the μ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence.
Buvidal 8 mg, 16 mg, 24 mg, 32 mg:
Pack sizes and Marketing
A 1 mL pre-filled syringe (glass, Type I) with plunger stopper (fluoropolymer-coated bromobutyl rubber) with needle (½-inch, 23 gauge, 12 mm) and needle shield (styrene butadiene rubber). The prefilled syringe is assembled in a safety device for post-injection needlestick prevention. The needle shield of the safety syringe may contain rubber latex that may cause allergic reactions in latexsensitive individuals.
Pack sizes: Pack contains 1 pre-filled syringe with stopper, needle, needle shield, safety device and 1 plunger rod.
Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden, Phone: +800 2577 2577
Date of first authorisation: 20 November 2018
Buvidal prolonged-release solution for injection (weekly)
EU/1/18/1336/001 [8 mg buprenorphine/0.16 mL]
EU/1/18/1336/002 [16 mg buprenorphine/0.32 mL]
EU/1/18/1336/003 [24 mg buprenorphine 0.48 mL]
EU/1/18/1336/004 [32 mg buprenorphine/0.64 mL]