VARIQUEL Solution for injection Ref.[8893] Active ingredients: Terlipressin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom

Product name and form

Variquel 0.2 mg/ml, solution for injection.

Pharmaceutical Form

Solution for injection.

Clear colourless aqueous solution with a pH of 5.7–6.3 and an osmolality of 270-330 mOsm/kg.

Qualitative and quantitative composition

Each 5 ml of injection solution contains 1 mg terlipressin acetate corresponding to 0.85 mg terlipressin.

Each ml contains 0.2 mg terlipressin acetate corresponding to 0.17 mg terlipressin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Terlipressin

Terlipressin inhibits portal hypertension with simultaneous reduction of blood circulation in portal vessels. Terlipressin contracts smooth oesophageal muscle with consecutive compression of oesophageal varices.

List of Excipients

Glacial acetic acid
Sodium acetate trihydrate
Water for injections

Pack sizes and marketing

Colourless glass type I vials, closed with bromobutyl rubber stopper and sealed with aluminium flip-off cap (green).

Each vial contains 5 ml of solution.

Pack sizes: 5 × 5ml.

Marketing authorization holder

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom

Marketing authorization dates and numbers

PL 16853/0149

18/10/2013

Drugs

Drug Countries
VARIQUEL Ireland, Malta, New Zealand, United Kingdom

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