European Union - English - EMA (European Medicines Agency)

immedica pharma ab - emedastine difumarate - conjunctivitis, allergic - ophthalmologicals - symptomatic treatment of seasonal allergic conjunctivitis.

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)

immedica pharma ab - glycerol phenylbutyrate - urea cycle disorders, inborn - other alimentary tract and metabolism products, - ravicti is indicated for use as adjunctive therapy for chronic management of patients with urea cycle disorders (ucds) including deficiencies of carbamoyl phosphate-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginase i (arg) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (hhh) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

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

immedica pharma ab - betaxolol hydrochloride - eye drops - 2.5mg/1ml

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

immedica pharma ab - betaxolol hydrochloride - eye drops - 5mg/1ml

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

immedica pharma ab - betaxolol hydrochloride - eye drops - 2.5mg/1ml

European Union - English - EMA (European Medicines Agency)

helsinn birex pharmaceuticals ltd - netupitant, palonosetron hydrochloride - vomiting; neoplasms; nausea; cancer - antiemetics and antinauseants, - akynzeo is indicated in adults for the:prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Israel - English - Ministry of Health

medison pharma ltd - glycerol phenylbutyrate - liquid - glycerol phenylbutyrate 1.1 g / 1 ml - glycerol phenylbutyrate - ravicti is indicated for use as adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age with urea cycle disorders (ucds) including deficiencies of carbamoyl phosphate-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginase i (arg) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (hhh) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Israel - English - Ministry of Health

medison pharma ltd - glycerol phenylbutyrate - liquid - glycerol phenylbutyrate 1.1 g / 1 ml - glycerol phenylbutyrate - ravicti is indicated for use as adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age with urea cycle disorders (ucds) including deficiencies of carbamoyl phosphate-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginase i (arg) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (hhh) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).

Israel - English - Ministry of Health

medison pharma ltd - glycerol phenylbutyrate - liquid - glycerol phenylbutyrate 1.1 g / 1 ml - glycerol phenylbutyrate - ravicti is indicated for use as adjunctive therapy for chronic management of adult and paediatric patients ≥2 months of age with urea cycle disorders (ucds) including deficiencies of carbamoyl phosphate-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginase i (arg) and ornithine translocase deficiency hyperornithinaemia-hyperammonaemia homocitrullinuria syndrome (hhh) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. ravicti must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements).