Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10780
Trade NameDose FormStrengthIdentifier
EntyvioPowder for injection300 mg
SponsorApplication dateRegistration situationClassification
Takeda New Zealand Limited
Level 10, 21 Queens Street
Auckland 1010
28/5/2020Consent given
Approval date: 1/9/2022
Notification date: 16/11/2022
Prescription
 

Composition

ComponentIngredientManufacturer
powder for injectionActive 
 Vedolizumab 300mgLonza 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 stepManufacturer
Finished Product TestingCatalent 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 - MicrobiologicalWickham Micro Limited
Hoeford Point
Barwell Lane
Gosport
Hampshire PO13 0AU
UNITED KINGDOM
Manufacture of Final Dose FormPatheon 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
PackingPatheon 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 PackagingTakeda Austria GmbH
St Peter Strasse 25
Linz A 4020
AUSTRIA
NZ Site of Product ReleaseDHL Supply Chain (New Zealand) Ltd
6 Manu Tapu Drive
Mangere
Auckland 2022

Packaging

PackageContentsShelf Life
Vial, glass, closed with a chlorobutyl rubber stopper and an aluminium overseal300 mg36 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 DateApplication TypeChange(s)StatusPayment DatePriority
12/1/2024Changed Medicine NotificationData sheet - G2Granted 9/2/202425/1/2024 
28/5/2020New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substancesGranted 1/9/202224/6/2020 
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