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APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN (Generic Partners Pty Ltd)

Product name
APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN
Date registered
Evaluation commenced
Decision date
Approval time
147 (255 working days)
Active ingredients
ciclosporin
Registration type
New generic medicine
Indication

APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN (soft capsule) 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. APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN 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 classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective.
  • In patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life.
  • For the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.

Careful monitoring of all ciclosporin-treated patients is mandatory. APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

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