ERLEADA Film-coated tablet Ref.[7617] Active ingredients: Apalutamide

Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Product name and form

Erleada 60 mg film-coated tablets.

Pharmaceutical Form
Film-coated tablet (tablet). Slightly yellowish to greyish green, oblong-shaped, film-coated tablets (16.7 mm long x 8.7 mm wide), debossed with “AR 60” on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 60 mg of apalutamide.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Apalutamide	Apalutamide is an orally administered, selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. Apalutamide treatment decreases tumor cell proliferation and increases apoptosis leading to potent antitumor activity.

List of Excipients
Tablet core: Colloidal anhydrous silica Croscarmellose sodium Hypromellose acetate succinate Magnesium stearate Microcrystalline cellulose Microcrystalline cellulose (silicified) Film-coating: Iron oxide black (E172) Iron oxide yellow (E172) Macrogol Polyvinyl alcohol (partially hydrolysed) Talc Titanium dioxide (E171)

Pack sizes and marketing

White opaque high-density polyethylene (HDPE) bottle with a polypropylene (PP) child-resistant closure. Each bottle contains 120 film-coated tablets and a total of 6 g of silica gel desiccant.

PVC-PCTFE foil blister with an aluminum push-through foil sealed inside a wallet pack.

Each 28-day carton contains 112 film coated tablets in 4 cardboard wallet packs of 28 film-coated tablets each.
Each 30-day carton contains 120 film coated tablets in 5 cardboard wallet packs of 24 film-coated tablets each.

Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Marketing authorization dates and numbers

EU/1/18/1342/001
EU/1/18/1342/002
EU/1/18/1342/003

Date of first authorisation: 14 January 2019

Drugs

Drug	Countries
ERLEADA	Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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