DEPO-PROVERA Suspension for injection Ref.[7815] Active ingredients: Medroxyprogesterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, CT13 9NJ, UK

Product name and form

Depo-Provera 150 mg/ml.

Pharmaceutical Form

Sterile suspension for injection.

Qualitative and quantitative composition

Each ml of suspension contains 150 mg medroxyprogesterone acetate.

Excipients with known effect:

Methylparaben (E218) – 1.35mg
Propylparaben (E216) – 0.15mg
Sodium chloride – 3.38mg

For the full list of excipients, see section 6.1.

Active Ingredient Description
Medroxyprogesterone

Medroxyprogesterone acetate exerts anti-oestrogenic, anti-androgenic and antigonadotrophic effects.

List of Excipients

Methylparaben (E218)
Macrogol 3350
Polysorbate 80
Propylparaben (E216)
Sodium chloride
Hydrochloric acid
Sodium hydroxide
Water for injections

Pack sizes and marketing

1 ml suspension for injection in a pre-filled glass syringe with halobutyl rubber plunger stopper and halobutyl rubber tip cap, packed singly.

1 ml suspension for injection in glass vials with halobutyl rubber stopper and aluminum cap with a plastic flip off in pack sizes of 1 or 25 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00057/0965

Date of first authorisation: 27 August 1991
Date of latest renewal: 6 February 1997

Drugs

Drug Countries
DEPO-PROVERA Australia, Brazil, Canada, Ecuador, Estonia, France, Hong Kong, Ireland, Israel, Lithuania, Mexico, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States, South Africa

© 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.