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
Illnois 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
 Contract Pharmaceutical Services of Australia Pty Ltd
5 Eden Park Drive
North Ryde
NSW 2113
Australia
Secondary PackagingContract Pharmaceutical Services of Australia Pty Ltd
5 Eden Park Drive
North Ryde
NSW 2113
Australia
 DHL Supply Chain (Australia) Pty Limited
52 Huntingwood Drive
Huntingwood
NSW 2148
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
6th Floor, 156-158 Victoria Street
Wellington 6011

Packaging

PackageContentsShelf Life
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).

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
29/7/2020Changed Medicine NotificationIndications/dosage - Grade 4; Data sheet - miscellaneous changes; Administrative fee (CMN)Awaiting payment  
29/6/2020CMN 24(5)Indications/dosage - Grade 1; Indications/dosage - Grade 4; Data sheet - miscellaneous changes; Administrative fee (CMN)Initial evaluation14/7/2020Y
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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