SYNAREL Nasal spray, solution Ref.[7666] Active ingredients: Nafarelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Product name and form

Synarel 2mg/ml Nasal Spray.

Pharmaceutical Form

Nasal spray, solution.

Clear, colourless to slightly yellow, aqueous solution.

Qualitative and quantitative composition

Solution containing 2mg/ml of nafarelin (as acetate) supplied in bottles fitted with a metered spray pump that delivers 200 micrograms of nafarelin base per spray.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nafarelin

Nafarelin is a potent agonistic analogue of gonadotrophin releasing hormone (GnRH). Given as a single dose, nafarelin stimulates release of the pituitary gonadotrophins, LH and FSH, with consequent increase of ovarian and testicular steroidogenesis.

List of Excipients

__Synarel contains:*

Sorbitol
Benzalkonium chloride
Glacial acetic acid and water
Sodium hydroxide or hydrochloric acid to adjust pH.

Pack sizes and marketing

White, high density polyethylene bottles with a 0.1ml metered spray pump, containing 6.5ml or 10ml.

PVC-coated glass bottles with an internal conical reservoir in the base and a valois pump, with either an aluminium crimp-on cap or a polypropylene snap-on cap, containing 4ml or 8ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization dates and numbers

PL 00057/1052

13 August 2003

Drugs

Drug Countries
SYNAREL Australia, Canada, Spain, France, Ireland, Israel, Netherlands, Turkey, United Kingdom, United States

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