MIFEGYNE Tablet Ref.[8334] Active ingredients: Mifepristone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Nordic Group B.V., Siriusdreef 22, 2132 WT Hoofddorp, The Netherlands

Product name and form

Mifegyne 200 mg tablets.

Pharmaceutical Form

Tablet.

Light yellow, cylindrical, bi-convex tablets, with a diameter of 11 mm with “167 B” engraved on one side.

Qualitative and quantitative composition

Each tablet contains 200-mg mifepristone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mifepristone

Mifepristone is a synthetic steroid with an antiprogestational action as a result of competition with progesterone at the progesterone receptors.

List of Excipients

Silica, colloidal anhydrous (E551)
Maize starch
Povidone (E1201)
Magnesium stearate (E572)
Cellulose microcrystalline (E460)

Pack sizes and marketing

PVC/aluminium perforated unit dose blister packs of 1, 3 × 1, 15 × 1 or 30 × 1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Nordic Group B.V., Siriusdreef 22, 2132 WT Hoofddorp, The Netherlands

Marketing authorization dates and numbers

PL 40621/0022

30/04/2017

Drugs

Drug Countries
MIFEGYNE Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Netherlands, New Zealand, Romania, Singapore, Tunisia, United Kingdom, South Africa

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