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AZATHIOPRINE / SANDOZ Film-coated tablets (2018)

Active ingredients: Azathioprine

Product Name and Form

Azathioprine 25 mg film-coated tablets.

Pharmaceutical form

Film-coated tablet.

White to yellowish-white film-coated tablet, biconvex, no score-line.

Qualitative and Quantitative Composition

One film-coated tablet contains 25 mg azathioprine.

Excipient(s) with known effect: Lactose

For the full list of excipients, see section 6.1.

Chemical substance
Description
Azathioprine

Azathioprine is a pro-drug of 6-mercaptopurine (6-MP). 6-MP is inactive but acts as a purine antagonist and requires cellular uptake and intracellular anabolism to thioguanine nucleotides (TGNs) for immunosuppression. The TGNs and other metabolites (e.g. 6-methyl-mecaptopurine ribonucleotides) inhibit de novo purine synthesis and purine nucleotide interconversions.

List of excipients

Core:

Lactose monohydrate
Maize starch
Povidone
Colloidal silicon dioxide
Magnesium stearate

Coating:

Hypromellose
Microcrystalline cellulose
Polyoxyl 8 stearate
Talc

Colouring agent:

titanium dioxide (E171)

Pack sizes and Marketing

The film-coated tablets are packed in either polypropylene-aluminium blister or PVC/PVDC-aluminium blister in a carton box.

The pack contains 20, 28, 30, 50, 90 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

25/10/2002

Marketing authorization number:

PL 04416/1247