VENCLYXTO Film-coated tablet Ref.[9093] Active ingredients: Venetoclax

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany

Product name and form

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.

Qualitative and quantitative composition

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 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 tablets

Tablet core:

Copovidone (K28)
Colloidal anhydrous silica (E551)
Polysorbate 80 (E433)
Sodium stearyl fumarate
Anhydrous calcium hydrogen phosphate (E341 (ii))

Film-coating:

Iron oxide yellow (E172)
Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 3350 (E1521)
Talc (E553b)

Venclyxto 50 mg film-coated tablets

Tablet core:

Copovidone (K28)
Colloidal anhydrous silica (E551)
Polysorbate 80 (E433)
Sodium stearyl fumarate
Anhydrous calcium hydrogen phosphate (E341 (ii))

Film-coating:

Iron oxide yellow (E172)
Iron oxide red (E172)
Iron oxide black (E172)
Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 3350 (E1521)
Talc (E553b)

Venclyxto 100 mg film-coated tablets

Tablet core:

Copovidone (K28)
Colloidal anhydrous silica (E551)
Polysorbate 80 (E433)
Sodium stearyl fumarate
Anhydrous calcium hydrogen phosphate (E341 (ii))

Film-coating:

Iron oxide yellow (E172)
Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 3350 (E1521)
Talc (E553b)

Pack sizes and marketing

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 tablets: The film-coated tablets are supplied in cartons containing either 10 or 14 tablets (in blisters of 2 tablets).

Venclyxto 50 mg tablets: The film-coated tablets are supplied in cartons containing either 5 or 7 tablets (in blisters of 1 tablet).

Venclyxto 100 mg 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.

Marketing authorization holder

AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany

Marketing authorization dates and numbers

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: 6 September 2018

Drugs

Drug Countries
VENCLYXTO Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom

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