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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