IMUPRIN Film-coated tablet Ref.[28123] Active ingredients: Azathioprine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Imuprin 50 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, round, film-coated tablets, scored and embossed with AZA and 50 on the same side.

The score line is not intended for breaking the tablet.

Qualitative and quantitative composition

Each film-coated tablet contains 50 mg azathioprine.

Excipient(s) with known effect: This product contains 69.8 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient 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
Cellulose, microcrystalline
Starch, pregelatinised
Silica, colloidal anhydrous
Magnesium stearate
Talc

Coating:

Hypromellose
Macrogol 400
Titanium dioxide E171
Quinoline yellow aluminium lake E104

Pack sizes and marketing

PVC/Aluminium blisters. Pack sizes of 20, 100 and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

9030

Date of first authorization: 15 September 1983
Date of latest renewal: 27 February 2009

Drugs

Drug Countries
IMUPRIN Cyprus, Hong Kong, Malta

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