ZOMIG Nasal spray Ref.[8083] Active ingredients: Zolmitriptan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Grรผnenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, UK

Product name and form

Zomig 5 mg Nasal Spray.

Pharmaceutical Form

Nasal Spray.

Qualitative and quantitative composition

Zomig Nasal Spray is an aqueous solution containing 50 mg/ml zolmitriptan, buffered to pH 5.0. The device delivers a unit dose of 5 mg and is intended for a single use only.

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Zolmitriptan

Zolmitriptan has been demonstrated to be a selective agonist for the vascular human recombinant 5HT1B and 5HT1D receptor subtypes. Zolmitriptan is a high affinity 5HT1B/1D receptor agonist with modest affinity for 5HT1A receptors.

List of Excipients

Each Zomig Nasal Spray vial contains the following excipients:

Citric acid
Disodium phosphate
Purified Water

Pack sizes and marketing

Ph Eur Type I glass vials which are closed with chlorobutyl rubber stoppers. The vials are assembled into a unit dose nasal spray device, comprising of a vial holder, an actuation device and a protection cover.

Packs containing 1, 2, or 6 single use devices.

Not all pack sizes may be marketed.

Marketing authorization holder

Grรผnenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, UK

Marketing authorization dates and numbers

PL 21727/0085

Date of first authorisation: 19th September 2002
Date of latest renewal: 18th June 2008

Drugs

Drug Countries
ZOMIG Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Singapore, United Kingdom, United States, South Africa

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