CRINONE Vaginal gel

Active ingredients: Progesterone

Product name and form

Crinone 8% w/w Progesterone Vaginal Gel.

Pharmaceutical Form

Vaginal gel.

Qualitative and quantitative composition

Active Ingredient:


Excipient with known effect: Contains Sorbic acid 0.08% w/w (0.9mg/1.125 g dose).

For the full list of excipients, see section 6.1.

Active Ingredient

Progesterone is a natural progestogen, the main hormone of the corpus luteum and the placenta. It acts on the endometrium by converting the proliferating phase to the secretory phase.

List of Excipients

Light Paraffin
Hydrogenated Palm Oil Glyceride
Carbopol 974P
Sorbic acid
Sodium hydroxide
Purified water

Pack sizes and marketing

A single use, one piece, white polyethylene applicator with a twist-off top, designed for intravaginal application.

Each applicator contains 1.45g of gel and delivers 1.125g of gel. Each one is wrapped up and sealed in a paper/aluminium/polyethylene foil overwrap.

The applicators are packed in cardboard boxes containing 6 or 15 units of Crinone 8% progesterone vaginal gel.

Marketing authorization holder

Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

Marketing authorization dates and numbers

PL 11648/0261

Date of first authorisation: 1st March 2013
Date of latest renewal: 26th June 2004


Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa