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

Israel - English - Ministry of Health

megapharm ltd - anakinra - solution for injection - anakinra 150 mg/ml - anakinra - anakinra - kineret 100 mg solution for injection is indicated in adults for the treatment of the signs and symptoms of rheumatoid arthritis (ra) in combination with methotrexate, in patients with an inadequate response to methotrexate alone.kineret 100 mg solution for injection is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of cryopyrin-associated periodic syndromes (caps), including:- neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca)- muckle-wells syndrome (mws)- familial cold autoinflammatory syndrome (fcas) kineret 100 mg solution for injection is indicated for the treatment of familial mediterranean fever (fmf). kineret 100 mg solution for injection should be given in combination with colchicine, if appropriate.

Israel - English - Ministry of Health

truemed ltd, israel - avatrombopag as maleate - film coated tablets - avatrombopag as maleate 20 mg - avatrombopag - for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)

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

swedish orphan biovitrum ltd - palifermin - powder for solution for injection - 6.25mg

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

swedish orphan biovitrum ltd - autologous human cartilage cells - implantation suspension - 10000cell/1microlitre

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

swedish orphan biovitrum ltd - efmoroctocog alfa - powder and solvent for solution for injection - 750unit

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

swedish orphan biovitrum ltd - glycerol phenylbutyrate - liquid - 1.1gram/1ml

European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - efmoroctocog alfa - hemophilia a - antihemorrhagics,  , - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).elocta can be used for all age groups.

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

swedish orphan biovitrum international ab, sweden - nitisinone - capsule, hard - 2 mg