Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands
Xtandi – 40 mg film-coated tablets.
Xtandi – 80 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Xtandi – 40 mg film-coated tablets: Yellow round – film-coated tablets, debossed with E40. Xtandi – 80 mg film-coated tablets: Yellow oval – film-coated tablets, debossed with E80. |
Xtandi – 40 mg film-coated tablets: Each film-coated tablet contains 40 mg of enzalutamide.
Xtandi – 80 mg film-coated tablets: Each film-coated tablet contains 80 mg of enzalutamide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Enzalutamide |
Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway. Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression. |
| List of Excipients |
|---|
|
Tablet core: Hypromellose acetate succinate Tablet coating: Hypromellose |
40 mg film-coated tablets: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 film-coated tablets. Each carton contains 112 film-coated tablets (4 wallets).
80 mg film-coated tablets: Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 14 film-coated tablets. Each carton contains 56 film-coated tablets (4 wallets).
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands
EU/1/13/846/002 (film-coated tablet 40 mg)
EU/1/13/846/003 (film-coated tablet 80 mg)
Date of first authorisation: 21 June 2013
Date of latest renewal: 8 February 2018
| Drug | Countries | |
|---|---|---|
| XTANDI | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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