NUBEQA Film-coated tablet Ref.[9925] Active ingredients: Darolutamide

Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bayer AG, 51368, Leverkusen, Germany

Product name and form

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.

Qualitative and quantitative composition

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. Darolutamide treatment decreases prostate tumour cell proliferation leading to potent antitumour activity.

List of Excipients
Tablet core: Calcium hydrogen phosphate (E341) Croscarmellose sodium Lactose monohydrate Magnesium stearate (E470b) Povidone (E1201) Film-coating: Hypromellose Lactose monohydrate Macrogol (E1521) Titanium dioxide (E171)

Pack sizes and marketing

PVC/Aluminium foil blisters containing 16 film-coated tablets.

Each pack contains 112 film-coated tablets.

Marketing authorization holder

Bayer AG, 51368, Leverkusen, Germany

Marketing authorization dates and numbers

EU/1/20/1432/001 112 film-coated tablets

Date of first authorisation: 27 March 2020

Drugs

Drug	Countries
NUBEQA	Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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