EZINELLE Tablet Ref.[49677] Active ingredients: Levonorgestrel

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Generics (UK) Ltd t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Ezinelle 1.5 mg tablet.

Pharmaceutical Form

Tablet.

The tablet is a round, white to off-white, uncoated flat tablet debossed ‘145’ on one side and plain on the other side.

Qualitative and quantitative composition

Each tablet contains 1.5 mg of levonorgestrel.

Excipient with known effect:

Each tablet contains 154 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levonorgestrel

The precise mode of action of levonorgestrel as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest.

List of Excipients

Povidone K-25
Lactose monohydrate
Maize starch
Silica, colloidal anhydrous
Magnesium stearate

Pack sizes and marketing

Blister composed of PVC film coated with PVDC and aluminium foil.

Pack size: 1 tablet.

Marketing authorization holder

Generics (UK) Ltd t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 04569/1486

13/05/2015

Drugs

Drug Countries
EZINELLE United Kingdom

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