Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Nova Laboratories Ireland Limited, 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
Jayempi 10 mg/ml oral suspension.
| Pharmaceutical Form |
|---|
|
Oral suspension. Yellow viscous suspension. |
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) |
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).
Nova Laboratories Ireland Limited, 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
EU/1/21/1557/001
Date of first authorisation: 21 June 2021
| Drug | Countries | |
|---|---|---|
| JAYEMPI | Austria, Estonia, Croatia, Ireland, Italy, Lithuania, Poland |
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