Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
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File ref: TT50-10780 |
Trade Name | Dose Form | Strength | Identifier |
Entyvio | Powder for injection | 300 mg | |
Sponsor | Application date | Registration situation | Classification |
Takeda New Zealand Limited Level 10, 21 Queens Street Auckland 1010 | 28/5/2020 | Consent given Approval date: 1/9/2022 Notification date: 16/11/2022 | Prescription |
Composition
Component | Ingredient | Manufacturer |
powder for injection | Active | |
Vedolizumab 300mg | Lonza Biologics Inc 101 International Drive Portsmouth New Hampshire 03801 UNITED STATES OF AMERICA | |
AbbVie Biotechnology Ltd Road No 2 Km 59.2 Barceloneta 00617 PUERTO RICO | ||
AbbVie Bioresearch Center 100 Research Drive Worcester Massachusetts 01605 UNITED STATES OF AMERICA | ||
Excipient | ||
Arginine hydrochloride | ||
Histidine | ||
Histidine hydrochloride monohydrate | ||
Polysorbate 80 | ||
Sucrose |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Catalent CTS Inc 10245 Hickman Mills Drive Kansas City Missouri 64137 UNITED STATES OF AMERICA |
Charles River Laboratories Germany GmbH Max-Planck-Strasse 15a Erkrath 40699 GERMANY | |
LabCorp Early Development Laboratories Limited Otley Road Harrogate North Yorkshire HG3 1PY UNITED KINGDOM | |
Patheon Italia S.p.A 2 Trav. SX, Via Morolense 5 Ferentino 03013 ITALY | |
Takeda Austria GmbH St Peter Strasse 25 Linz A 4020 AUSTRIA | |
Takeda Pharmaceutical Company Limited Hikari Plant 4720 Mitsui Hikari-city Yamaguchi 743-8502 JAPAN | |
Finished Product Testing - Microbiological | Wickham Micro Limited Hoeford Point Barwell Lane Gosport Hampshire PO13 0AU UNITED KINGDOM |
Manufacture of Final Dose Form | Patheon Italia S.p.A 2 Trav. SX, Via Morolense 5 Ferentino 03013 ITALY |
Takeda Pharmaceutical Company Limited Hikari Plant 4720 Mitsui Hikari-city Yamaguchi 743-8502 JAPAN | |
Packing | Patheon Italia S.p.A 2 Trav. SX, Via Morolense 5 Ferentino 03013 ITALY |
Takeda Pharmaceutical Company Limited Hikari Plant 4720 Mitsui Hikari-city Yamaguchi 743-8502 JAPAN | |
Secondary Packaging | Takeda Austria GmbH St Peter Strasse 25 Linz A 4020 AUSTRIA |
NZ Site of Product Release | DHL Supply Chain (New Zealand) Ltd 6 Manu Tapu Drive Mangere Auckland 2022 |
Packaging
Package | Contents | Shelf Life |
Vial, glass, closed with a chlorobutyl rubber stopper and an aluminium overseal | 300 mg | 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. in sWFI 8 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. in Lactated Ringers (time includes that stored reconstituted) 12 hours diluted stored at or below 25°C protect from light. in saline (time includes that stored reconstituted) 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. in saline (time includes that stored reconstituted, and up to 12 hours spent at room temp) |
Indications
Treatment of adult patients with moderate to severe ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNF alpha) antagonist.
Treatment of adult patients with moderate to severe Crohn's disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNF alpha) antagonist.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
12/1/2024 | Changed Medicine Notification | Data sheet - G2 | Granted 9/2/2024 | 25/1/2024 | |
28/5/2020 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 1/9/2022 | 24/6/2020 |