JAYEMPI Oral suspension Ref.[50007] Active ingredients: Azathioprine

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Nova Laboratories Ireland Limited, 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

Product name and form

Jayempi 10 mg/ml oral suspension.

Pharmaceutical Form

Oral suspension.

Yellow viscous suspension.

Qualitative and quantitative composition

Each ml of suspension contains 10 mg azathioprine.

Excipients with known effect: The suspension contains 1.5 mg sodium benzoate (E211) in each ml.

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

Sodium benzoate (E211)
Sucralose (E955)
Banana flavour
Citric acid monohydrate
Microcrystalline cellulose and carmellose sodium
Xanthan gum
Purified water

Pack sizes and marketing

Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 200 ml of oral suspension.

Each pack contains one bottle, an HDPE bottle adaptor, a 3 mL polyethylene oral dosing syringe with red plunger (0.1 mL dose graduations) and a 12 mL polyethylene oral dosing syringe with white plunger (0.25 mL dose graduations).

Marketing authorization holder

Nova Laboratories Ireland Limited, 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

Marketing authorization dates and numbers

EU/1/21/1557/001

Date of first authorisation: 21 June 2021

Drugs

Drug Countries
JAYEMPI Estonia, Ireland, Lithuania, Poland

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