European Union - English - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - amino acid metabolism, inborn errors - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.1).

European Union - English - EMA (European Medicines Agency)

ptc therapeutics international limited - ataluren - muscular dystrophy, duchenne - other drugs for disorders of the musculo-skeletal system - translarna is indicated for the treatment of duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. efficacy has not been demonstrated in non-ambulatory patients.the presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ptc therapeutics ltd - ataluren - granules - 125mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ptc therapeutics ltd - ataluren - granules - 250mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ptc therapeutics ltd - ataluren - granules - 1gram

Israel - English - Ministry of Health

medison pharma ltd - ataluren - granules for oral suspension - ataluren 1000 mg - ataluren - translarna is indicated for the treatment of duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. the presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.

Israel - English - Ministry of Health

medison pharma ltd - ataluren - granules for oral suspension - ataluren 125 mg - ataluren - translarna is indicated for the treatment of duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. the presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing

Israel - English - Ministry of Health

medison pharma ltd - ataluren - granules for oral suspension - ataluren 250 mg - ataluren - translarna is indicated for the treatment of duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older. the presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

ptc therapeutics international limited, ireland - ataluren - granules for oral suspension - 250 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

ptc therapeutics international limited, ireland - ataluren - granules for oral suspension - 1000 mg