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).

United States - English - NLM (National Library of Medicine)

ptc therapeutics, inc. - deflazacort (unii: kr5yz6ae4b) (deflazacort - unii:kr5yz6ae4b) - deflazacort 6 mg - emflaza is indicated for the treatment of duchenne muscular dystrophy (dmd) in patients 2 years of age and older. emflaza is contraindicated in patients with known hypersensitivity to deflazacort or to any of the inactive ingredients.  instances of hypersensitivity, including anaphylaxis, have occurred in patients receiving corticosteroid therapy [see warnings and precautions (5.15) and adverse reactions (6.2)] . risk summary corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.  there are no adequate and well-controlled studies with emflaza in pregnant women to inform drug-associated risks. corticosteroids, including emflaza, readily cross the placenta.  adverse developmental outcomes, including orofacial clefts (cleft lip, with or without cleft palate) and intrauterine growth restrictio

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

Australia - English - Department of Health (Therapeutic Goods Administration)

demax medical australia pty ltd - 47732 - angioplasty catheter, balloon dilatation, coronary, basic - ptca semi-compliant balloon dilatation catheter is a rapid exchange of the catheter using a guidewire. the proximal shaft is a ptfe coated stainless steel tube which allows for proximal pushability with a smooth transition to the distal shaft which has a lubricious coating. balloon allows for high pressure dilatation. two radiopaque platinum markers are located within the balloon. the ptca balloon dilatation catheter is intended for dilatation of the stenotic portion (non-cto) of coronary arteries for the purpose of improving myocardial perfusion.

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.