Skip to main content

Table 1 Off-label use.

From: Off-label use in germany - a current appraisal of gynaecologic university departments

Legal consideration (rechtl. Regelung) in Germany Status of administration Medical requirement
Pharmaceutical law not regulated; permitted within therapeutic flexibility of the physician, reimbursement in §35bSGBV Permitted in different indication (in Germany) Life-threatening diseases without alternative therapeutic option and good evidence for therapeutic success
  1. (out of reference [1]), SGBV (Sozialgesetzbuch 5): Social Security Code 5