Azacitidine Mylan
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Azacitidine
- Made by
- Mylan Pharmaceuticals Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), chronic myelomonocytic leukaemia (CMML) with 10 29% marrow blasts without myeloproliferative disorder, acute myeloid leukaemia (AML) with 20 30% blasts and multi lineage dysplasia, according to World Health Organisation (WHO) classification, AML with > 30% marrow blasts according to the WHO classification.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (ONUREG). It describes the substance, not this exact product.
Azacitidine is a pyrimidine nucleoside analog of cytidine that inhibits DNA/RNA methyltransferases.
Azacitidine is incorporated into DNA and RNA following cellular uptake and enzymatic biotransformation to nucleotide triphosphates.
Effect of Food A high-fat, high-calorie meal (approximately 800 to 1000 calories, 50% fat) did not affect AUC 0-INF and decreased C max by 21%.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-06-12
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Mylan Pharmaceuticals Limited |
|---|---|
| Active substance | Azacitidine |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L01BC07 · Cancer treatments and immune-system medicines |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2020-03-27 |
| Last updated by the regulator | 2026-06-12 |
| EMA product number | EMEA/H/C/004984 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.