Lacosamide Accord Den Europæiske Union - dansk - EMA (European Medicines Agency)

lacosamide accord

accord healthcare s.l.u. - lacosamid - epilepsi - antiepileptika, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. •         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Hopveus Den Europæiske Union - dansk - EMA (European Medicines Agency)

hopveus

d&a pharma - natriumoxybat - substance withdrawal syndrome; alcohol abstinence - andre narkotika stoffer - substitution treatment for alcohol dependence within a framework of careful medical supervision along with continuous psychosocial support and social rehabilitation. treatment should be initiated only in patients resistant to existing interventions or in patients for whom existing therapies are contra-indicated or not recommended.

Roctavian Den Europæiske Union - dansk - EMA (European Medicines Agency)

roctavian

biomarin international limited - valoctocogene roxaparvovec - antihemorrhagics - treatment of severe haemophilia a (congenital factor viii deficiency) in adult patients without a history of factor viii inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (aav5).

Cortavance Den Europæiske Union - dansk - EMA (European Medicines Agency)

cortavance

virbac s.a. - hydrocortisonacceponat - corticosteroider, dermatologiske præparater - hunde - til symptomatisk behandling af inflammatoriske og pruritiske dermatoser hos hunde. for alleviation of clinical signs associated with atopic dermatitis in dogs.

Ribavirin Teva Pharma B.V. Den Europæiske Union - dansk - EMA (European Medicines Agency)

ribavirin teva pharma b.v.

teva b.v. - ribavirin - hepatitis c kronisk - antivirale midler til systemisk anvendelse - ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) in adults (see sections 4. 2, 4. 4 og 5. ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) for paediatric patients (children 3 years of age and older and adolescents) notpreviously treated and without liver decompensation (see sections 4. 2, 4. 4 og 5.

Xeplion Den Europæiske Union - dansk - EMA (European Medicines Agency)

xeplion

janssen-cilag international n.v. - paliperidonpalmitat - skizofreni - psykoleptika - xeplion er indiceret til vedligeholdelsesbehandling af skizofreni hos voksne patienter stabiliseret med paliperidon eller risperidon. in selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

Teysuno Den Europæiske Union - dansk - EMA (European Medicines Agency)

teysuno

nordic group b.v. - tegafur, gimeracil, oteracil - mave neoplasmer - antineoplastiske midler - teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5. - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.

Travatan Den Europæiske Union - dansk - EMA (European Medicines Agency)

travatan

novartis europharm limited - travoprost - glaucoma, open-angle; ocular hypertension - oftalmologiske - reduktion af forhøjet intraokulært tryk hos voksne patienter med okulær hypertension eller åbenvinklet glaukom (se afsnit 5. nedsættelse af forhøjet intraokulært tryk hos pædiatriske patienter i alderen fra 2 måneder til < 18 år med okulær hypertension eller pædiatriske grøn stær (se afsnit 5.

ViraferonPeg Den Europæiske Union - dansk - EMA (European Medicines Agency)

viraferonpeg

merck sharp dohme ltd  - peginterferon alfa-2b - hepatitis c kronisk - immunostimulants, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. der henvises til ribavirin og boceprevir produktresuméer (smpcs), når viraferonpeg skal anvendes i kombination med disse lægemidler. adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. viraferonpeg i kombination med ribavirin (bitherapy) er indiceret til behandling af chc-infektion hos voksne patienter, der er tidligere ubehandlet, herunder patienter med klinisk stabilt hiv co-infektion, og hos voksne patienter, der har undladt tidligere behandling med interferon alfa (pegyleret eller non-pegyleret) og ribavirin kombination terapi eller interferon alfa-monoterapi. interferon monoterapi, herunder viraferonpeg, er indikeret primært i tilfælde af intolerance eller kontraindikation for ribavirin. der henvises til ribavirin spc, når viraferonpeg er at blive brugt i kombination med ribavirin. paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna. når det besluttes ikke at udsætte behandlingen, indtil voksenalderen, det er vigtigt at overveje, at kombinationen af terapi-induceret vækst-hæmning, der kan være uoprettelige hos nogle patienter. beslutningen om at behandle en sag-for-sag. der henvises til ribavirin produktresumeet for kapsler eller oral opløsning, når viraferonpeg er at blive brugt i kombination med ribavirin.