Subutex 2mg sublingual tablets Ref.[2580] Active ingredients: Buprenorphine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2012  Publisher: RB Pharmaceuticals Ltd 103 – 105 Bath Road, Slough Berkshire SL1 3UH

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.

Active Ingredient 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

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

Marketing authorization dates and numbers

Subutex 2 mg, sublingual tablets: PL 36699/0002

February 1998 (UK)

Drugs

Drug Countries
SUBUTEX Austria, Australia, Germany, Finland, France, Croatia, Ireland, Israel, Lithuania, Malta, Singapore, United Kingdom

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