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Risk minimization activity or Risk minimization measure:

Is defined as an intervention intended to prevent or reduce the probability of the occurrence of an adverse reaction associated with the exposure to a medicine, or to reduce its severity should it occur. These activities may consist of routine risk minimization (e.g. product information) or additional risk minimization activities (e.g. healthcare professional or patient communications/educational materials etc…).




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Risk minimization activity List

Drug Name
#DateProductRiskMeasures
19/2018

Esbriet® (pirfenidone)

         For the Safe use of medicine.

29/2018

​Remsima ® ( Infliximab )

         -   Serious infections including sepsis and Tuberculosis 
       -   HBV reactivation

39/2016

Salbutamol  (Farcolin®)

           Microbial contamination

49/2016

​Denosumab (Prolia®)

           ​Osteonecrosis of the Jaw

59/2016

​Clozapine (Leponex®)

           Severe neutropenia (Agranulocytosis)

69/2016

​Canagliflozin (Invokana®)

           Risk of diabetic ketoacidosis 

78/2019

​Soliqua (lixisenatide /insuline glargin)

     -  Important information on dosing

88/2019

​Prograf (tacrolimus)

    Risk Minimisation Information for Patients

98/2019

​Exjade (deferasirox)

    Risk Minimisation Information for healthcare professional

108/2017

FEGONA® (fingolimod)

  • Visual symptoms
  • Liver function
  • Pregnancy
  • Bradycardia
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