Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
---|---|---|
File ref: TT50-10324a |
Trade Name | Dose Form | Strength | Identifier |
Truxima | Concentrate for infusion | 500 mg/50mL | |
Sponsor | Application date | Registration situation | Classification |
Celltrion Healthcare New Zealand Limited Floor 1, 103 Carlton Gore Road Newmarket Auckland 1023 | 8/1/2018 | Consent given Approval date: 15/8/2019 Notification date: 2/5/2022 | Prescription |
Reference product: Mabthera Concentrate for infusion 10 mg/mL |
Composition
Component | Ingredient | Manufacturer |
concentrate for infusion | Active | |
Rituximab 10 mg/mL | Celltrion Inc. Plant II 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 step | Manufacturer |
Finished Product Testing | Celltrion Inc. Plant I (CLT1) 23, Academy-ro Yeonsu-gu Incheon 22014 South Korea |
Celltrion Inc. Plant II 20, Academy-ro 51 beon-gil Yeonsu-gu Incheon 22014 South Korea | |
Manufacture of Final Dose Form | Celltrion Inc. Plant II 20, Academy-ro 51 beon-gil Yeonsu-gu Incheon 22014 South Korea |
Packing | Celltrion Inc. Plant II 20, Academy-ro 51 beon-gil Yeonsu-gu Incheon 22014 South Korea |
NZ Site of Product Release | Celltrion Healthcare New Zealand Limited Floor 1, 103 Carlton Gore Road Newmarket Auckland 1023 |
Packaging
Package | Contents | Shelf Life |
Vial, glass, single dose, Type 1 glass, with chlorobutyl rubber stopper and Al seal | 50 mL | 48 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
31/5/2023 | Changed Medicine Notification | Active ingredient method of manufacture - G1; Active ingredient method of manufacture - G2; Active ingredient method of manufacture - G3; Finished product manufacturing process - G1; Finished product manufacturing process - G2; Finished product manufacturing process - G3; Test methods and specifications - G1; Test methods and specifications - G2; Test methods and specifications - G3; Shelf life/storage conditions - G2; Container/closure/packaging - G2; Container/closure/packaging - G3; Administrative fee (CMN) | Granted 11/9/2023 | 21/6/2023 | |
8/1/2018 | New Higher-risk Medicine Application | Abridged new higher-risk medicine not containing a new active substance | Granted 15/8/2019 | 29/1/2018 |