PRAZIQUANTEL Tablets Ref.[8692] Active ingredients:

Source: European Medicines Agency (EU)  Revision Year: 2017  Publisher: Cipla Ltd., Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai: 400013, India

Product name and form

Praziquantel 600mg Tablets.

Pharmaceutical Form

Tablet.

White to orange tinged, film coated, capsule shaped tablet with two scores and central breakline on both sides. The tablet is coded with “C” and “L” on one side.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 600 mg praziquantel.

For the full list of excipients, see section 6.1.

List of Excipients

Core tablet: Corn starch, croscarmellose sodium, magnesium stearate , microcrystalline cellulose, povidone, sodium lauryl sulfate.

Tablet coating: Hypromellose, titanium dioxide, macrogol.

Pack sizes and marketing

180 cc or 900 cc white HDPE container with white HDPE screw caps having 2 silica gel bags of 1gm and Rayon Sani coil (Pack sizes: 100 and 500 tablets).

Marketing authorization holder

Cipla Ltd., Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai: 400013, India

Marketing authorization dates and numbers

NT 003 (WHO)

16 December 2015

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