PROTIONAMIDE Film-coated tablet Ref.[9600] Active ingredients:

Source: European Medicines Agency (EU)  Revision Year: 2016  Publisher: Supplier: Micro Labs Limited, #27, Race Course Road, Bangalore 560 001, Karnataka, India, Tel: +91-80-2237 0451 to 2237 0457, Fax: +91-80-2237 0463, Email: jainethesh@microlabs.in

Product name and form

Protionamide 250 mg Tablets*.

* Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s (NMRA) responsibility. Throughout this WHOPAR the proprietary name is given as an example only.

Pharmaceutical Form

Film-coated tablet.

Orange coloured, circular biconvex, film-coated tablets with score on one face and plain on the other.

The tablets can be divided into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 250 mg protionamide.

Each tablet contains a small amount of FD&C yellow #6/sunset yellow FCF Aluminium Lake.

For a full list of excipients, see section 6.1.

List of Excipients

Core tablet: Colloidal anhydrous silica, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, polysorbate 80 and povidone.

Seal coating: Hypromellose and polyethylene glycol.

Film coating (Opadry 02F83057 Orange): FD&C yellow #6/sunset yellow FCF aluminium lake, hypromellose, polyethylene glycol, talc and titanium dioxide.

Pack sizes and marketing

Blister pack: White opaque PVC/PVDC-Alu blisters. 10 or 14 tablets per blister card, 10 cards per box.

Bottle pack: White round HDPE bottle with CRC cap.100 tablets per bottle.

Marketing authorization holder

Supplier: Micro Labs Limited, #27, Race Course Road, Bangalore 560 001, Karnataka, India, Tel: +91-80-2237 0451 to 2237 0457, Fax: +91-80-2237 0463, Email: jainethesh@microlabs.in

Marketing authorization dates and numbers

WHO REFERENCE NUMBER (PREQUALIFICATION PROGRAMME): TB239

25 February 2013

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