Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Nova Laboratories Ireland Limited, 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
Xromi 100 mg/ml oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear, colourless to pale yellow viscous liquid. |
One ml of solution contains 100 mg hydroxycarbamide.
Excipients with known effect: One ml of solution contains 0.5 mg methyl hydroxybenzoate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hydroxycarbamide |
One of the mechanisms by which hydroxycarbamide acts is the elevation of foetal haemoglobin (HbF) concentrations in sickle cell patients. In addition hydroxycarbamide causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or protein. |
| List of Excipients |
|---|
|
Xanthan gum (E415) |
Amber type III glass bottle with tamper evident child-resistant closure (HDPE with expanded polyethylene liner) containing 150 ml of oral solution.
Each pack contains one bottle, an HDPE bottle adaptor and 2 polyethylene dosing syringes (a red syringe graduated to 3 ml and a white syringe graduated to 12 ml).
Nova Laboratories Ireland Limited, 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
EU/1/19/1366/001
Date of first authorisation: 01 July 2019
| Drug | Countries | |
|---|---|---|
| XROMI | Austria, Estonia, France, Croatia, Ireland, Lithuania, Poland, United Kingdom |
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