PRANDIN E2 Vaginal Gel Ref.[50238] Active ingredients: Dinoprostone

Source: Marketing Authorisation Holder  Revision Year: 2018  Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196, South Africa

Product name and form

PRANDIN E2 1mg (Vaginal Gel).

PRANDIN E2 2Mg (Vaginal Gel).

Pharmaceutical Form

Vaginal Gel.

Qualitative and quantitative composition

Each unit dose of 3,0 grams (2,5 ml) contains 1,0 mg or 2,0 mg dinoprostone.

Active Ingredient Description
Dinoprostone
List of Excipients

Pack sizes and marketing

A colourless, semi-translucent, viscous gel.

PRANDIN E2 1 mg or 2 mg Vaginal Gel is supplied as a semi-translucent, thixotropic sterile gel as follows: 1 mg or 2 mg PGE2 per 3 g in syringes for intravaginal application.

Marketing authorization holder

Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton, 2196, South Africa

Marketing authorization dates and numbers

PRANDIN E2 1 mg Vaginal Gel: W/19/455
PRANDIN E2 2 mg Vaginal Gel: W/19/456

Date of registration: 12 September 1990
Date of last SAHPRA approval: 11 August 2006

Drugs

Drug Countries
PRANDIN E2 United Kingdom, South Africa

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