LUTIGEST Vaginal tablet Ref.[7855] Active ingredients: Progesterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Product name and form

Lutigest 100 mg vaginal tablets.

Pharmaceutical Form

Vaginal tablet.

White to off-white flat and oval tablet with the inscriptions “FPI” on one side and “100” on the other side.

The vaginal tablets are supplied with one polyethylene vaginal applicator.

Qualitative and quantitative composition

1 vaginal tablet contains 100 mg progesterone.

Excipient with known effect: 1 vaginal tablet contains approximately 760 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description

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

Silica, hydrophobic colloidal
Lactose monohydrate
Pregelatiniszed maize starch
Povidone K29/32
Adipic acid
Sodium hydrogen carbonate
Sodium laurilsulfate
Magnesium stearate

Pack sizes and marketing

Alu/Alu blisters of 3 vaginal tablets.

The blisters are available in cartons with 21 or 90 vaginal tablets with 1 vaginal applicator.

Not all pack sizes may be marketed.

Marketing authorization holder

Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Marketing authorization dates and numbers

PL 03194/0103



Drug Countries
LUTIGEST United Kingdom

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