Table 4 Waiver conditions of ‘adults only’ OD
Medicine name (active substance) | Paediatric use | Paediatric investigation plan | ||||
|---|---|---|---|---|---|---|
Potential paediatric* | On label† | Decision‡ | Condition and age covered by waiver | Ground for waiver | Expected date of completion PIP for remaining population | |
Arzerra (ofatumumab) | No | No | CW | Chronic lymphocytic leukaemia (birth to <18y) | Class waiver | NA |
Imnovid (pomalidomide) | No | No | CW | Multiple myeloma (birth to <18y) | Class waiver | NA |
Jakavi (ruxolitinib) | No | No | CW | Myeolofibrosis (birth to <18y) | Class waiver | NA |
Thalidomide Celgene (thalidomide) | No | No | CW | Multiple myeloma (birth to <18y ) | Class waiver | NA |
Afinitor (everolimus) | No | No | PSW | Renal cell carcinoma and pancreatic neuroendocrine tumour (birth to <18y) | Condition occurs only in adult populations | NA |
Esbriet (pirfenidone) | No | No | PSW | Idiopathic Pulmonary Fibrosis (birth to <18y) | Condition occurs only in adult populations | NA |
Nexavar § (Sorafenib) | No | No | PSW | Differentiated thyroid cancer (birth to <18y) | No significant therapeutic benefit over existing treatments for paediatric patients. | NA |
Revlimid (lenalidomide) | No | No | PSW | Multiple myeloma and myelodysplastic syndromes (birth to <18 y) | Likely unsafe | NA |
Torisel (temsirolimus) | No | No | PSW | For the treatment of mantle-cell lymphoma for all subsets of the paediatric | Condition occurs only in adult populations | NA |
Bosulif (bosutinib) | No | No | PW | Chronic myeloid leukaemia (birth to <10 y) | Condition occurs only in adult populations | December 2016 |
Tasigna (Nilotinib) | No | No | PW | Gastro-intestinal stromal tumour (0-18y) and chronic myeloid leukaemia (0-1y) | No significant therapeutic benefit | September 2015 |
Volibris (ambrisentan) | No | No | PW | Pulmonary arterial hypertension (0-1y) | Likely unsafe | December 2016 |