Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10122a |
| Trade Name | Dose Form | Strength | Identifier |
| Venclexta | Film coated tablet | 50 mg | |
| Sponsor | Application date | Registration situation | Classification |
| AbbVie Limited P O Box 11437 Manners Street Wellington 6142 | 13/3/2017 | Consent given Approval date: 2/11/2017 Notification date: 30/7/2018 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| film coated tablet | Active | |
| Venetoclax 50mg | AbbVie 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 step | Manufacturer |
| Finished Product Testing | AbbVie 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 Form | AbbVie Ireland NL B.V. Manorhamilton Road Sligo Ireland |
| Fournier Laboratories Ireland Limited Anngrove Carrigtwohill County Cork Ireland | |
| Manufacture of Intermediate Product | AbbVie Deutschland GmbH & Co KG Knollstrasse Ludwigshafen 67061 Germany |
| Packing | AbbVie Inc 1 North Waukegan Road North Chicago Illinois 60064 United States of America |
| Secondary Packaging | DHL 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 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 Release | AbbVie Limited 156-158 Victoria Street Wellington 6011 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard carton | 1 tablets | 24 months from date of manufacture stored at or below 30°C |
| Blister pack, PVC/PE/Aclar/Al foil blisters in cardboard wallet | 7 tablets | 24 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 27/6/2023 | Self-Assessable Change Notification | Labelling - G1 (Self assessable) | Notified | 3/7/2023 | |
| 13/3/2017 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 2/11/2017 | 20/3/2017 |
