Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Bayer AG, 51368, Leverkusen, Germany
NUBEQA 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). White to off-white, oval tablets with a length of 16 mm and a width of 8 mm, marked with “300” on one side, and “BAYER” on the other side. |
Each film-coated tablet contains 300 mg of darolutamide.
Excipient with known effect: Each film-coated tablet contains 186 mg of lactose monohydrate (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Darolutamide |
Darolutamide is an androgen receptor (AR) inhibitor with a flexible polar-substituted pyrazole structure that binds with high affinity directly to the receptor ligand binding domain. Darolutamide competitively inhibits androgen binding, AR nuclear translocation, and AR mediated transcription. A major metabolite, keto-darolutamide, exhibited similar in vitro activity to darolutamide. Darolutamide treatment decreases prostate tumour cell proliferation leading to potent antitumour activity. |
| List of Excipients |
|---|
|
Tablet core: Calcium hydrogen phosphate (E341) Film-coating: Hypromellose |
PVC/Aluminium foil blisters containing 16 film-coated tablets.
Each pack contains 96 or 112 film-coated tablets.
Not all pack sizes may be marketed.
Bayer AG, 51368, Leverkusen, Germany
EU/1/20/1432/001 112 film-coated tablets
EU/1/20/1432/002 96 film-coated tablets
Date of first authorisation: 27 March 2020
| Drug | Countries | |
|---|---|---|
| NUBEQA | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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