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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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#DateProductRiskMeasures
15/2016

​Deferasirox (Exjade®)

Administration and mentoring.​

25/2016

Salbutamol  (Butalin®)

- Growth.

- Risk of Contamination Risk of Contamination .

35/2016

​Alemtuzumab (Lemtrada®)

- Nephropathies including anti-GBM disease.

 

- Thyroid DisordersThyroid Disorders.

 

- Serious InfectionsSerious Infections

43/2016

​Ranibizumab (Lucentis®)

- Endophthalmitis.

 

- Cataract.

 

- Intraocular pressure increased

 

- Overdose due to overfill of the prefilled syringe.Overdose due to overfill of the prefilled syringe.

53/2016

​Golimumab (Simponi®)

- Serious infections including opportunistic infections and TB.

 

- Hepatitis B virus reactivation.

 

- Congestive heart failure. Congestive heart failure.

 

- Serious systemic hypersensitivity.

 

- Skin cancer.

 

- Administration error.

63/2016

​Methylphenidate (Ritalin®)

- Growth.

 

- Psychiatric and cardiovascular status monitoring.

73/2016

​Daratumumab (Darzalex®)

Interference with blood compatibility testing .

83/2016

​Eltrombopag (Revolade®)

- Hepatotoxicity.

 

- Thrombotic/thromboembolic complications.Thrombotic/thromboembolic complications.

 

- Bone marrow reticulin formation Risk for bone marrow fibrosis Haematological malignancies.

 

- Post therapy thrombocytopenia Interactions with foods.Post therapy thrombocytopenia Interactions with foods.

93/2016

​Mycophenolate mofetil  (Cellcept®)

- Teratogenicity.Teratogenicity.

 

- spontaneous abortions.

 

- congenital malformations following exposure during pregnancy.

102/2016

​Zoledronic acid (Zometa®)

Osteonecrosis of the jaw (ONJ).

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