DIETHYLCARBAMAZINE Tablet Ref.[9604] Active ingredients: Diethylcarbamazine

Source: European Medicines Agency (EU)  Revision Year: 2013  Publisher: SUPPLIER: Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan, Phone: +81 3 3817 3684, Fax: +81 3 3811 2710, Email: mailto: Eisai-asia_safety@hhc.eisai.co.jp

Product name and form

Diethylcarbamazine Citrate Tablets 100 mg USP (DEC Tablets)* (diethylcarbamazine citrate).

* Trade names are not prequalified by WHO. This is the responsibility of the local Drug Regulatory Authority. Throughout this WHOPAR the proprietary name is given as an example only.

Pharmaceutical Form

Tablet.

White to off white, uncoated, circular, flat bevelled-edged tablets debossed with “Є” on one side and plain with a break line on the other side.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 100 mg diethylcarbamazine citrate (equivalent to 50.9 mg diethylcarbamazine).

Excipient(s): 81 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Diethylcarbamazine

Diethylcarbamazine citrate is a synthetic piperazine derivative with an antihelmintic action. MDA of diethylcarbamazine citrate has potential to interrupt the parasitic life cycle by destruction of microfilariae which are essential for host to vector transmission of the parasite.

List of Excipients

Lactose monohydrate
Corn starch
Povidone (K-30)
Magnesium stearate
Talc

Pack sizes and marketing

Diethylcarbamazine Citrate Tablets are supplied in bulk in a white 400 cc high density polyethylene bottle with a white polypropylene cap having an induction seal and with the inclusion of two 2 gram silica gel desiccant packets.

Each bottle contains 1000 tablets.

Marketing authorization holder

SUPPLIER: Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan, Phone: +81 3 3817 3684, Fax: +81 3 3811 2710, Email: mailto: Eisai-asia_safety@hhc.eisai.co.jp

Marketing authorization dates and numbers

WHO REFERENCE NUMBER (PREQUALIFICATION PROGRAMME): NT002

20 August 2013

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