IMIGRAN Nasal spray, solution Ref.[7805] Active ingredients: Sumatriptan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Glaxo Wellcome UK Ltd Trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Product name and form

Imigran 10 mg Nasal Spray.

Pharmaceutical Form

Nasal Spray, solution.

Clear pale yellow to dark yellow liquid, in glass vials in a single dose nasal spray device.

Qualitative and quantitative composition

Imigran 10 mg Nasal Spray: Unit dose spray device for intranasal administration. The device delivers 10 mg of sumatriptan in 0.1 mL of an aqueous buffered solution.

For the 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

Potassium dihydrogen phosphate
Dibasic sodium phosphate anhydrous
Sulphuric acid
Sodium hydroxide
Purified water

Pack sizes and marketing

The container consists of a type I Ph.Eur. glass vial with rubber stopper and applicator.

Imigran 10 mg Nasal Spray: unit dose spray device containing 0.1mL solution.

Pack contains 1, 2, 4, 6, 12, or 18 sprays.

Not all pack sizes may be marketed.

Marketing authorization holder

Glaxo Wellcome UK Ltd

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

Marketing authorization dates and numbers

Imigran 10mg Nasal Spray: PL 10949/0260

Date of first authorisation: 29/05/1996
Date of last renewal: 29/03/2006

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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