CRINONE Vaginal gel Ref.[7856] Active ingredients: Progesterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

Product name and form

Crinone 8% w/w Progesterone Vaginal Gel.

Pharmaceutical Form

Vaginal gel.

Qualitative and quantitative composition

Active Ingredient:

 mg/dose%w/w
Progesterone908.0

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 Description
Progesterone

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

Glycerin
Light Paraffin
Hydrogenated Palm Oil Glyceride
Carbopol 974P
Sorbic acid
Polycarbophil
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

Drugs

Drug Countries
CRINONE Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈