Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Onureg 200 mg film-coated tablets.
Onureg 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Onureg 200 mg film-coated tablets: Pink, oval, film-coated tablet, 17.0 × 7.6 mm, debossed with “200” on one side and “ONU” on the other side. Onureg 300 mg film-coated tablets: Brown, oval, film-coated tablet, 19.0 × 9.0 mm, debossed with “300” on one side and “ONU” on the other side. |
Onureg 200 mg film-coated tablets: Each film-coated tablet contains 200 mg azacitidine.
Excipient with known effect: Each film-coated tablet contains 3.61 mg of lactose (as lactose monohydrate).
Onureg 300 mg film-coated tablets: Each film-coated tablet contains 300 mg azacitidine.
Excipient with known effect: Each film-coated tablet contains 5.42 mg of lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Azacitidine |
Azacitidine is believed to exert its antineoplastic effects by multiple mechanisms including cytotoxicity on abnormal haematopoietic cells in the bone marrow and hypomethylation of DNA. The cytotoxic effects of azacitidine may result from multiple mechanisms, including inhibition of DNA, RNA and protein synthesis, incorporation into RNA and DNA, and activation of DNA damage pathways. |
| List of Excipients |
|---|
|
Tablet content: Croscarmellose sodium (E468) Onureg 200 mg tablet coating: Opadry II pink containing: Hypromellose (E464) Onureg 300 mg tablet coating: Opadry II brown containing: Hypromellose (E464) |
The film-coated tablets are packaged in nylon (OPA) / polyvinyl chloride (PVC) aluminium blisters with push through aluminium foil.
Pack size of 7 or 14 film-coated tablets.
Not all pack sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Onureg 200 mg film-coated tablets:
EU/1/21/1556/001
EU/1/21/1556/002
Onureg 300 mg film-coated tablets:
EU/1/21/1556/003
EU/1/21/1556/004
Date of first authorisation: 17 June 2021
| Drug | Countries | |
|---|---|---|
| ONUREG | Austria, Estonia, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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