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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.

Pharmaceutical form

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.

Chemical substance
Description
Buprenorphine

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.

List of excipients

Buvidal 8 mg, 16 mg, 24 mg, 32 mg:

Soybean phosphatidylcholine
Glycerol dioleate
Ethanol anhydrous

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.

Marketing authorization holder
Authorization dates

Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden, Phone: +800 2577 2577

Date of first authorisation: 20 November 2018

Marketing authorization number:

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]