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 P O Box 2194 Auckland 1140 | 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 |
| 15/3/2024 | CMN 24(5) | Active ingredient method of manufacture - G2; Active ingredient method of manufacture - G4; Finished product secondary packing site; Finished product manufacturing process - G1; Test methods and specifications - G2; Excipient methods of manufacture - G2; Administrative fee (CMN) | Pending | ||
| 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 |
