Reason for request

Renewal of inclusion

Improve compliance with the measures for prescribing and dispensing in women of childbearing potential to prevent pregnancy under treatment and for 2 years after discontinuation. 

 

  • SORIATANE has Marketing Authorisation in the treatment of psoriasis, severe keratinisation disorders and severe forms of lichen planus.
  • Pregnancies have occurred under treatment due to lack of compliance with the prescribing and dispensing conditions.
  • The role of SORIATANE in the therapeutic strategy has not changed, but the teratogenic risk and the restrictions imposed on women of childbearing potential, up to 2 years after the last dose, must be considered in the choice of this medicinal product.

Clinical Benefit

Substantial

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