VERZENIOS Film-coated tablet Ref.[7607] Active ingredients: Abemaciclib

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands

Product name and form

Verzenios 50 mg film-coated tablets.

Verzenios 100 mg film-coated tablets.

Verzenios 150 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Verzenios 50 mg film-coated tablets: Beige, oval tablet of 5.2 × 9.5 mm, debossed with “Lilly” on one side and “50” on the other.

Verzenios 100 mg film-coated tablets: White, oval tablet of 6.6 × 12.0 mm, debossed with “Lilly” on one side and “100” on the other.

Verzenios 150 mg film-coated tablets: Yellow, oval tablet of 7.5 × 13.7 mm, debossed with “Lilly” on one side and “150” on the other.

Qualitative and quantitative composition

Verzenios 50 mg film-coated tablets: Each film-coated tablet contains 50 mg abemaciclib.

Excipients with known effect: Each film-coated tablet contains 14 mg of lactose monohydrate.

Verzenios 100 mg film-coated tablets: Each film-coated tablet contains 100 mg abemaciclib.

Excipients with known effect: Each film-coated tablet contains 28 mg of lactose monohydrate.

Verzenios 150 mg film-coated tablets: Each film-coated tablet contains 150 mg abemaciclib.

Excipients with known effect: Each film-coated tablet contains 42 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Abemaciclib

Abemaciclib is a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), and most active against Cyclin D1/CDK4 in enzymatic assays. Abemaciclib prevents retinoblastoma protein (Rb) phosphorylation, blocking cell cycle progression from the G1 to the S-phase of cell division, leading to suppression of tumour growth.

List of Excipients

Tablet core:

Croscarmellose sodium
Lactose monohydrate
Microcrystalline cellulose
Colloidal hydrated silica
Sodium stearyl fumarate

Film coating:

Verzenios 50 mg film-coated tablets:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol (E1521)
Talc (E553b)
Iron oxide yellow (E172)
Iron oxide red (E172)

Verzenios 100 mg film-coated tablets:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol (E1521)
Talc (E553b)

Verzenios 150 mg film-coated tablets:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol (E1521)
Talc (E553b)
Iron oxide yellow (E172)

Pack sizes and marketing

PCTFE/PE/PVC blisters sealed with an aluminium foil in a calendar blister card, in packs of 14, 28, 42, 56, 70 or 168 film-coated tablets.

Aluminium/aluminium perforated unit dose blisters of 28 × 1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands

Marketing authorization dates and numbers

EU/1/18/1307/001
EU/1/18/1307/002
EU/1/18/1307/003
EU/1/18/1307/004
EU/1/18/1307/005
EU/1/18/1307/006
EU/1/18/1307/007
EU/1/18/1307/008
EU/1/18/1307/009
EU/1/18/1307/010
EU/1/18/1307/011
EU/1/18/1307/012
EU/1/18/1307/013
EU/1/18/1307/014
EU/1/18/1307/015
EU/1/18/1307/016
EU/1/18/1307/017
EU/1/18/1307/018
EU/1/18/1307/019
EU/1/18/1307/020
EU/1/18/1307/021

Date of first authorisation: 27 September 2018

Drugs

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

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