Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Venclyxto 10 mg film-coated tablets.
Venclyxto 50 mg film-coated tablets.
Venclyxto 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Venclyxto 10 mg film-coated tablet: Pale yellow, round biconvex shaped tablet 6 mm diameter debossed with V on one side and 10 on the other. Venclyxto 50 mg film-coated tablet: Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other. Venclyxto 100 mg film-coated tablet: Pale yellow, oblong biconvex shaped tablet 17.2 mm long, 9.5 mm wide debossed with V on one side and 100 on the other. |
Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg of venetoclax.
Venclyxto 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of venetoclax.
Venclyxto 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of venetoclax.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Venetoclax |
Venetoclax is a potent, selective inhibitor of B-cell lymphoma (BCL)-2, an anti-apoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL and AML cells where it mediates tumour cell survival and has been associated with resistance to chemotherapeutics. Venetoclax binds directly to the BH3-binding groove of BCL-2, displacing BH3 motif-containing pro-apoptotic proteins like BIM, to initiate mitochondrial outer membrane permeabilization (MOMP), caspase activation, and programmed cell death. |
| List of Excipients |
|---|
Venclyxto 10 mg film-coated tabletsTablet core: Copovidone (K28) Film-coating: Iron oxide yellow (E172) Venclyxto 50 mg film-coated tabletsTablet core: Copovidone (K28) Film-coating: Iron oxide yellow (E172) Venclyxto 100 mg film-coated tabletsTablet core: Copovidone (K28) Film-coating: Iron oxide yellow (E172) |
Venclyxto film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blisters containing either 1, 2 or 4 film-coated tablets.
Venclyxto 10 mg film-coated tablets: The film-coated tablets are supplied in cartons containing either 10 or 14 tablets (in blisters of 2 tablets).
Venclyxto 50 mg film-coated tablets: The film-coated tablets are supplied in cartons containing either 5 or 7 tablets (in blisters of 1 tablet).
Venclyxto 100 mg film-coated tablets: The film-coated tablets are supplied in cartons containing either 7 (in blisters of 1 tablet) or 14 tablets (in blisters of 2 tablets); or a multipack containing 112 tablets (4 × 28 tablets (in blisters of 4 tablets)).
Not all pack sizes may be marketed.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
EU/1/16/1138/001 (10 mg, 10 tablets)
EU/1/16/1138/002 (10 mg, 14 tablets)
EU/1/16/1138/003 (50 mg, 5 tablets)
EU/1/16/1138/004 (50 mg, 7 tablets)
EU/1/16/1138/005 (100 mg 7 tablets)
EU/1/16/1138/006 (100 mg, 14 tablets)
EU/1/16/1138/007 (100 mg, 112 (4 × 28) tablets)
Date of first authorisation: 5 December 2016
Date of latest renewal: 11 August 2023
| Drug | Countries | |
|---|---|---|
| VENCLYXTO | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom |
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