Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-9443/1 |
| Trade Name | Dose Form | Strength | Identifier |
| Remsima SC | Solution for injection | 120 mg/mL | Pre-filled pen |
| Sponsor | Application date | Registration situation | Classification |
| Celltrion Healthcare New Zealand Limited 103 Carlton Gore Road Newmarket Auckland 1023 | 24/4/2020 | Consent given Approval date: 1/6/2023 | Prescription |
| Reference product: Remicade Powder for injection 100 mg | |||
Composition
| Component | Ingredient | Manufacturer |
| solution for injection | Active | |
| Infliximab 120 mg/mL | Celltrion Inc. Plant I (CLT1) 23, Academy-ro Yeonsu-gu Incheon 22014 South Korea | |
| Excipient | ||
| Acetic acid | ||
| Polysorbate 80 | ||
| Sodium acetate trihydrate | ||
| Sorbitol | ||
| 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 | |
| Kymos Pharma Services SL Ronda de Can Fatjo 7B (Parque Tecnologico del Valles) Cerdanyola del Valles Barcelona 08290 Spain | |
| SHL Pharma LLC 588 Jim Moran Boulevard Deerfield Beach FL 33442 United States of America | |
| Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 Germany | |
| Vetter Pharma-Fertigung GmbH & Co KG Helmut-Vetter-Str. 10 Ravensburg Baden Wurttemberg 88213 Germany | |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 Germany | |
| Vetter Pharma-Fertigung GmbH & Co KG Schuetzenstrasse 87, 99-101 Ravensburg D-88212 Germany | |
| Manufacture of Final Dose Form | Vetter Pharma-Fertigung GmbH & Co KG Schuetzenstrasse 87, 99-101 Ravensburg D-88212 Germany |
| Secondary Packaging | Celltrion Inc. Plant II 20, Academy-ro 51 beon-gil Yeonsu-gu Incheon 22014 South Korea |
| SHL Pharma LLC 588 Jim Moran Boulevard Deerfield Beach FL 33442 United States of America | |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 Germany | |
| NZ Site of Product Release | Celltrion Healthcare New Zealand Limited 103 Carlton Gore Road Newmarket Auckland 1023 |
Packaging
| Package | Contents | Shelf Life |
| Syringe, glass, pre-fitted into an autoinjector | 1 mL | 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days not refrigerated stored at or below 25°C protect from light. no return to refrigeration |
Indications
Rheumatoid arthritis
Remsima SC, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
o adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
o adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated (see section 5.1).
Crohn's disease
Remsima SC is indicated for:
o treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
o treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Ulcerative colitis
Remsima SC is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Ankylosing spondylitis
Remsima SC is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Psoriatic arthritis
Remsima SC is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Remsima SC should be administered
o in combination with methotrexate
o or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1).
Psoriasis
Remsima SC is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 24/4/2020 | New Higher-risk Medicine Application | Additional dose form - higher-risk medicine - Grade 1 or 2 | Granted 1/6/2023 | 7/5/2020 |
