Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-10324a
Trade NameDose FormStrengthIdentifier
TruximaConcentrate for infusion500 mg/50mL
SponsorApplication dateRegistration situationClassification
Celltrion Healthcare New Zealand Limited
P O Box 2194
Level 10, 203 Queen Street
Auckland Central
Auckland 1010
8/1/2018Not available
Approval date: 15/8/2019
Notification date: 19/9/2019
Prescription
Reference product: Mabthera Concentrate for infusion 10 mg/mL

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Rituximab 10 mg/mLCelltrion Inc.
Plant II (CLT2)
20, Academy-ro 51 beon-gil
Yeonsu-gu
Incheon 22014
South Korea
 Excipient 
 Polysorbate 80
 Sodium chloride
 Sodium citrate dihydrate
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingCelltrion Inc.
Plant I (CLT1)
23, Academy-ro
Yeonsu-gu
Incheon 22014
South Korea
 Celltrion Inc.
Plant II (CLT2)
20, Academy-ro 51 beon-gil
Yeonsu-gu
Incheon 22014
South Korea
Manufacture of Final Dose FormCelltrion Inc.
Plant II (CLT2)
20, Academy-ro 51 beon-gil
Yeonsu-gu
Incheon 22014
South Korea
PackingCelltrion Inc.
Plant II (CLT2)
20, Academy-ro 51 beon-gil
Yeonsu-gu
Incheon 22014
South Korea
NZ Site of Product ReleaseCelltrion Healthcare New Zealand Limited
P O Box 2194
Level 10, 203 Queen Street
Auckland Central
Auckland 1010

Packaging

PackageContentsShelf Life
Vial, glass, single dose, Type 1 glass, with chlorobutyl rubber stopper and Al seal50 mL48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Indications

Indicated for the treatment of patients with:
- CD20 positive, previously untreated low-grade or follicular, B-Cell non Hodgkin's lymphoma in combination with chemotherapy.
- CD20 positive, relapsed or chemoresistant low-grade or follicular, B-cell non-Hodgkin's lymphoma.
- CD20 positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy.

Indicated for maintenance treatment of patients with CD20 positive, low grade or follicular, B-cell non-Hodgkin's lymphoma.

In combination with chemotherapy is indicated for the treatment of patients with chronic lymphocytic leukaemia.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
14/10/2019Changed Medicine NotificationTest methods and specifications - Grade 3; Active ingredient method of manufacture - Grade 2; Test methods and specifications - Grade 4; Shelf life/storage conditions - Active ingredient and intermediate bulks; Shelf life/storage conditions - finished product; Administrative fee (CMN)Granted 3/12/201931/10/2019 
8/1/2018New Higher-risk Medicine ApplicationAbridged new higher-risk medicine not containing a new active substanceGranted 15/8/201929/1/2018 
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /