Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
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. |
Each film-coated tablet contains 50 mg abemaciclib.
Excipients with known effect: Each film-coated tablet contains 14 mg of lactose monohydrate.
Each film-coated tablet contains 100 mg abemaciclib.
Excipients with known effect: Each film-coated tablet contains 28 mg of lactose monohydrate.
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 Film coating: Verzenios 50 mg film-coated tablets Polyvinyl alcohol (E1203) Verzenios 100 mg film-coated tablets Polyvinyl alcohol (E1203) Verzenios 150 mg film-coated tablets Polyvinyl alcohol (E1203) |
PCTFE/PE/PVC blisters sealed with an aluminium foil 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.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
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
Date of latest renewal: 23 June 2023
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