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
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. |
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. |
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.
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
WHO REFERENCE NUMBER (PREQUALIFICATION PROGRAMME): TB239
25 February 2013
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