European Union - English - EMA (European Medicines Agency)

eurocept international b. v. - para-aminosalicylic acid - tuberculosis - antimycobacterials - granupas is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see section 4.4).consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

eurocept international b. v. - sodium phenylbutyrate - carbamoyl-phosphate synthase i deficiency disease - various alimentary tract and metabolism products - treatment of chronic management of urea-cycle disorders.

European Union - English - EMA (European Medicines Agency)

eurocept international bv - carglumic acid - hyperammonemia; amino acid metabolism, inborn errors - other alimentary tract and metabolism products, - ucedane is indicated in treatment of:hyperammonaemia due to n-acetylglutamate synthase primary deficiency;hyperammonaemia due to isovaleric acidaemia;hyperammonaemia due to methymalonic acidaemia;hyperammonaemia due to propionic acidaemia.

Ireland - English - HPRA (Health Products Regulatory Authority)

eurocept international bv - lidocaine; tetracaine - medicated plaster - 70 mg/70 milligram(s) - amides; lidocaine, combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

eurocept international bv - amsacrine - concentrate and solvent for concentrate for solution for infusion - 75 mg/1.5 millilitre(s) - other antineoplastic agents; amsacrine

Malta - English - Medicines Authority

eurocept international bv trapgans 5, 1244rl ankeveen, netherlands - amsacrine - concentrate and solvent for solution for infusion - amsacrine 50 mg/ml - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

eurocept international bv - amsacrine - powder for solution for infusion - amsacrine

Israel - English - Ministry of Health

truemed ltd, israel - 4 - aminosalicylic acid - gastro resistant granules - 4 - aminosalicylic acid 4 g/sachet - 4-aminosalicylic acid - granupas is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Israel - English - Ministry of Health

truemed ltd, israel - sodium phenylbutyrate - granules - sodium phenylbutyrate 483 mg/g - sodium phenylbutyrate - pheburane is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate 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.

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

eurocept international bv - amsacrine - solution for infusion - 50mg/1ml