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Subutex 2mg sublingual tablets (2012)

Active ingredients: Buprenorphine

Product Name and Form

SUBUTEX 2 mg sublingual tablets.

Pharmaceutical form

Sublingual tablet.

Qualitative and Quantitative Composition

Buprenorphine hydrochloride equivalent to buprenorphine base: 2 mg.

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

Monohydrated lactose
Mannitol
Maize starch
Povidone excipients k30
Citric Acid
Sodium citrate
Magnesium stearate

Pack sizes and Marketing

7 or 28 tablets in nylon/aluminium/uPVC blister packs.

Marketing authorization holder
Authorization dates

RB Pharmaceuticals Ltd
103 – 105 Bath Road, Slough
Berkshire
SL1 3UH

February 1998 (UK)

Marketing authorization number:

Subutex 2 mg, sublingual tablets: PL 36699/0002