XTANDI Film-coated tablet Ref.[9661] Active ingredients: Enzalutamide

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands

Product name and form

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.

Qualitative and quantitative composition

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
Microcrystalline cellulose
Colloidal anhydrous silica
Croscarmellose sodium
Magnesium stearate

Tablet coating:

Hypromellose
Talc
Macrogol (8000)
Titanium dioxide (E171)
Iron oxide yellow (E172)

Pack sizes and marketing

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).

Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE, Leiden, The Netherlands

Marketing authorization dates and numbers

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

Drugs

Drug Countries
XTANDI Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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