NORLEVO Tablet Ref.[51098] Active ingredients: Levonorgestrel

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Laboratoire HRA Pharma, 200 avenue de Paris, 92320 CHATILLON, France

Product name and form

NORLEVO 1.5 mg tablet.

Pharmaceutical Form

Tablet.

White, round biconvex tablet engraved with code NL 1.5 on one face.

Qualitative and quantitative composition

Each tablet contains 1.5 mg levonorgestrel.

Excipient with known effect: each tablet contains 90.90 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

Lactose monohydrate
Maize starch
Povidone
Colloidal anhydrous silica
Magnesium stearate

Pack sizes and marketing

PVC/PE/PVDC/Aluminium blister of 1 tablet.

Pack sizes with 1 tablet and 5, 10, 25 or 50 tablets as hospital packs only.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoire HRA Pharma, 200 avenue de Paris, 92320 CHATILLON, France

Marketing authorization dates and numbers

PA1166/002/001

Date of first authorisation: 26th August 2005
Date of last renewal: 19th April 2009

Drugs

Drug Countries
NORLEVO Cyprus, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Netherlands, Tunisia, South Africa

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