Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10122a
Trade NameDose FormStrengthIdentifier
VenclextaFilm coated tablet50 mg
SponsorApplication dateRegistration situationClassification
AbbVie Limited
P O Box 11437
Manners Street
Wellington 6142
13/3/2017Consent given
Approval date: 2/11/2017
Notification date: 30/7/2018
Prescription
 

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Venetoclax 50 mgAbbVie Operations Singapore Pte Ltd
23 Tuas South Avenue 6 637 022
Singapore
  AbbVie Ireland NL B.V.
Manorhamilton Road
Sligo
Ireland
 Excipient 
 Calcium hydrogen phosphate
 Colloidal silicon dioxide
 Copovidone
 Opadry II beige 85F97497
 Polysorbate 80
 Purified water
 Sodium stearyl fumarate

Production

Manufacturing stepManufacturer
Finished Product TestingAbbVie Inc
1401 Sheridan Road
North Chicago
Illinois 60064-4000
United States of America
 AbbVie Ireland NL B.V.
Manorhamilton Road
Sligo
Ireland
 Fournier Laboratories Ireland Limited
Anngrove
Carrigtwohill
County Cork
Ireland
Manufacture of Final Dose FormAbbVie Ireland NL B.V.
Manorhamilton Road
Sligo
Ireland
 Fournier Laboratories Ireland Limited
Anngrove
Carrigtwohill
County Cork
Ireland
Manufacture of Intermediate ProductAbbVie Deutschland GmbH & Co KG
Knollstrasse
Ludwigshafen 67061
Germany
PackingAbbVie Inc
1 North Waukegan Road
North Chicago
Illinois 60064
United States of America
Secondary PackagingDHL Supply Chain (Australia) Pty Limited
25 Ottelia Road
Kemps Creek
NSW 2178
Australia
 Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022
 UPS SCS Nederland BV
Albert Einsteinweg 11
Roermond
Limberg 6045 GX
Netherlands
 UPS SCS Nederland BV
Marco Poloweg 22-24
Venlo
Limberg 5928 LE
Netherlands
 Zuellig Pharma Specialty Solutions Group Pte Ltd
15 Changi North Way
#01-02, #02-02, #02-10 498770
Singapore
NZ Site of Product ReleaseAbbVie Limited
156-158 Victoria Street
Wellington 6011

Packaging

PackageContentsShelf Life
Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard carton1 tablets24 months from date of manufacture stored at or below 30°C
Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard wallet7 tablets24 months from date of manufacture stored at or below 30°C

Indications

VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

VENCLEXTA is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
6/12/2021Changed Medicine NotificationLabelling - Grade 2; Administrative fee (CMN)Granted 13/1/20229/12/2021 
13/3/2017New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 2/11/201720/3/2017 
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