Revised SPC: Translarna (ataluren) -

Revised SPC: Translarna (ataluren)
Information type: Drug prescribing
Source: electronic Medicines compendium
Specialities: Cardiovascular system disorders | Musculo-skeletal disorders | Neurological disorders | Paediatric and neonatal medicine
Summary
SPC revised to state that safety and efficacy in children <12kg and aged 6 months to 2 years have not yet been established; no data are available. Paediatric patients with body weight ≥12 kg are treated as per the dosing recommendations by body weight range in dosing table.
UKMi comment
SPC now also states that an increase in serum lipids has been observed and in some cases, this increase to abnormally high values was already observed after 4 weeks.
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