Export

ATC codes: L04AD01
EMLc
Indication
Failure or rejection of transplanted organs or tissues ICD11 code: NE84
INN
Ciclosporin
Medicine type
Chemical agent
List type
Complementary For organ transplantation.
Formulations
Parenteral > General injections > IV: 50 mg per mL in 1 mL ampoule concentrate for injection
Oral > Solid: 25 mg
EML status history
First added in 1991 (TRS 825)
Changed in 1999 (TRS 895)
Changed in 2002 (TRS 914)
Changed in 2003 (TRS 920)
Changed in 2007 (TRS 950)
Sex
All
Age
Also recommended for children
Therapeutic equivalence
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
The EMLc Subcommittee endorsed the inclusion of ciclosporin on the complementary list of the EMLc for use as an immunosuppressive medicine. Given the limited information available on the use of azathioprine and ciclosporin in children, the Subcommittee recommended that reviews be commissioned for both drugs for consideration at the next meeting for the EMLc. The Subcommittee also requested information on the availability of paediatric-appropriate forms. In reviewing the section of the list for antineoplastic and immunosuppressive medicines, the Subcommittee recognized the importance of access to these medicines. Furthermore, the need for access to specialist centres was emphasized. The list of immunosuppressants and cytotoxics was thought to be comprehensive. The EMLc Subcommittee agreed that the currently listed medicines should be retained, even though the evidence for efficacy and safety in children was not reviewed. The medicines should be linked to treatment protocols.