XTANDI Soft capsule Ref.[9661] Active ingredients: Enzalutamide

Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Product name and form

Xtandi – 40 mg soft capsules.

Pharmaceutical Form
Soft capsule. White to off-white oblong soft capsules (approximately 20 mm x 9 mm) imprinted with “ENZ” in black ink on one side.

Qualitative and quantitative composition

Xtandi – 40 mg soft capsules

Each soft capsule contains 40 mg of enzalutamide.

Excipient(s) with known effect:

Each soft capsule contains 57.8 mg of sorbitol.

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
Capsule contents: Caprylocaproyl macrogol-8 glycerides Butylhydroxyanisole (E320) Butylhydroxytoluene (E321) Capsule shell: Gelatin Sorbitol sorbitan solution Glycerol Titanium dioxide (E171) Purified water Printing ink: Iron oxide black (E172) Polyvinyl acetate phthalate

Pack sizes and marketing

Cardboard wallet incorporating a PVC/PCTFE/aluminium blister of 28 soft capsules. Each carton contains 4 wallets (112 soft capsules).

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/13/846/001

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, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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