ESPRANOR Oral lyophilisate Ref.[49987] Active ingredients: Buprenorphine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Martindale Pharmaceuticals Ltd, Bampton Road, Romford, Essex, RM3 8UG, United Kingdom

Product name and form

Espranor 2 mg oral lyophilisate.

Pharmaceutical Form

Oral lyophilisate.

White to off-white circular oral lyophilisate with a diameter of 10.3 mm, debossed with ‘M2’ on one side.

Qualitative and quantitative composition

Each oral lyophilisate contains 2 mg of buprenorphine (as hydrochloride).

Excipient with known effect: Each oral lyophilisate contains 0.50 mg aspartame.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Buprenorphine

Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the ÎŒ (mu) and Îș (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the ÎŒ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence.

List of Excipients

Gelatin
Mannitol
Aspartame (E951)
Mint flavour (051296 TP0551)
Anhydrous citric acid

Pack sizes and marketing

Unit dose blisters composed of PVC/OPA/Al/OPA/PVC film with Al/PET/paper lidding with 7 × 1 or 28 × 1 oral lyophilisates, in a cardboard carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Martindale Pharmaceuticals Ltd, Bampton Road, Romford, Essex, RM3 8UG, United Kingdom

Marketing authorization dates and numbers

PL 00156/0364

22/06/2015

Drugs

Drug Countries
ESPRANOR Ireland, United Kingdom

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