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CICLOSPORIN STR (Strides Pharma Science Pty Ltd)
Product name
CICLOSPORIN STR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
101 (255 working days)
Active ingredients
ciclosporin
Registration type
New generic medicine
Indication
[TRADE NAME] is indicated:
- As an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation.
- For induction and/or maintenance of remission in the nephrotic syndrome. Ciclosporin is not a first-line agent. Its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see Section 4.4 Special Warnings and Precautions for Use).
- For the treatment of severe, active rheumatoid arthritis in patients for whom classicalslow-acting antirheumatic agents (including methotrexate) are inappropriate orineffective.
- In patients with severe psoriasis in whom conventional therapy is ineffective orinappropriate and the disease has caused a significant interference with quality of life.
- For the treatment of severe atopic dermatitis when other treatment is ineffective orinappropriate. Careful monitoring of all ciclosporin-treated patients is mandatory. Ciclosporin should onlybe used by medical practitioners who are experienced in the use of immunosuppressivetherapy (see Section 4.4 Special Warnings and Precautions for Use).