European Union - English - EMA (European Medicines Agency)

recordati rare diseases - zinc - hepatolenticular degeneration - other alimentary tract and metabolism products, - treatment of wilson's disease.

Israel - English - Ministry of Health

megapharm ltd - nitisinone - hard capsule - nitisinone 2 mg - nitisinone - nitisinone - treatment of patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht-1) in combination with dietary restriction of tyrosine and phenylalanine05/06/2018 בקשה לשינוי משטר מינון once daily

Israel - English - Ministry of Health

megapharm ltd - nitisinone - hard capsule - nitisinone 5 mg - nitisinone - nitisinone - treatment of patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht-1) in combination with dietary restriction of tyrosine and phenylalanine05/06/2018 בקשה לשינוי משטר מינון once daily

Israel - English - Ministry of Health

megapharm ltd - nitisinone - hard capsule - nitisinone 10 mg - nitisinone - nitisinone - treatment of patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht-1) in combination with dietary restriction of tyrosine and phenylalanine05/06/2018 בקשה לשינוי משטר מינון once daily

European Union - English - EMA (European Medicines Agency)

immedica pharma ab - sodium phenylbutyrate - ornithine carbamoyltransferase deficiency disease; citrullinemia; carbamoyl-phosphate synthase i deficiency disease - other alimentary tract and metabolism products, - ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase.it is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). it is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.

European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitisinone - tyrosinemias - other alimentary tract and metabolism products, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine.alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

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

swedish orphan biovitrum ltd - sodium phenylbutyrate - tablet - 500mg

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

swedish orphan biovitrum ltd - sodium phenylbutyrate - granules - 940mg/1gram

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

swedish orphan biovitrum ltd - nitisinone - capsule - 2mg

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

swedish orphan biovitrum ltd - nitisinone - capsule - 5mg