IMIGRAN Solution for injection Ref.[7804] Active ingredients: Sumatriptan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Glaxo Wellcome UK Limited Trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Product name and form

Imigran Injection.

Imigran Subject.

Pharmaceutical Form

Pre-filled syringes for use in conjunction with an auto injector for subcutaneous injection.

Qualitative and quantitative composition

Each pre-filled syringe contains 6 mg of sumatriptan base, as the succinate salt, in an isotonic solution of 0.5 ml.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Sumatriptan

Sumatriptan has been demonstrated to be a specific and selective 5-Hydroxytryptamine1 (5HT1D) receptor agonist with no effect on other 5HT receptor (5-HT2 - 5-HT7) subtypes. The vascular 5-HT1D receptor is found predominantly in cranial blood vessels and mediates vasoconstriction.

List of Excipients

Sodium chloride
Water for injection

Pack sizes and marketing

Treatment pack: 2 pre-filled syringes (in cases) plus an auto-injector, in a plastic tray within a carton.

Refill pack: 2 pre-filled syringes (in cases) in a carton or 6 pre-filled syringes (ie three cases each containing 2 pre-filled syringes).

Marketing authorization holder

Glaxo Wellcome UK Limited

Trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Marketing authorization dates and numbers

PL 10949/0113

Date of first authorisation: 31 December 1993
Date of latest renewal: 11 July 2007

Drugs

Drug Countries
IMIGRAN Austria, Australia, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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