LEVONELLE Tablet Ref.[50141] Active ingredients: Levonorgestrel

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Product name and form

Levonelle 1500 microgram tablet.

Pharmaceutical Form

Tablet.

Almost white, flat, rimmed tablet of about 8 mm diameter with an impressed mark of “G00” on one side.

Qualitative and quantitative composition

Each tablet contains 1500 micrograms of levonorgestrel.

Excipient with known effect: 142.5 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

Potato starch
Maize starch
Colloidal silica anhydrous
Magnesium stearate
Talc
Lactose monohydrate

Pack sizes and marketing

PVC/Aluminium-blister containing one tablet. The blister is packaged in a folded carton.

Marketing authorization holder

Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Marketing authorization dates and numbers

PL 04854/0150

14th June 2004

Drugs

Drug Countries
LEVONELLE New Zealand, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.