Sibnayal União Europeia - dinamarquês - EMA (European Medicines Agency)

sibnayal

advicenne s.a. - potassium citrate monohydrated, potassium hydrogen carbonate - acidosis, renal tubular - mineral supplements - sibnayal is indicated for the treatment of distal renal tubular acidosis (drta) in adults, adolescents and children aged one year and older.

Ontozry União Europeia - dinamarquês - EMA (European Medicines Agency)

ontozry

angelini pharma s.p.a - cenobamate - epilepsi - antiepileptika, - adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.

Icatibant Accord União Europeia - dinamarquês - EMA (European Medicines Agency)

icatibant accord

accord healthcare s.l.u. - icatibant acetate - angioødemer, arvelige - other hematological agents - icatibant accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (hae) in adults, adolescents and children aged 2 years and older, with c1 esterase inhibitor deficiency.

Bonqat União Europeia - dinamarquês - EMA (European Medicines Agency)

bonqat

orion corporation - pregabalin - antiepileptika - katte - alleviation of acute anxiety and fear associated with transportation and veterinary visits.

Zenalpha União Europeia - dinamarquês - EMA (European Medicines Agency)

zenalpha

vetcare oy - medetomidine hydrochloride, vatinoxan hydrochloride - psycholeptics, hypnotika og sedativa - hunde - to provide restraint, sedation and analgesia during conduct of non-invasive, non-painful or mildly painful procedures and examinations intended to last no more than 30 minutes.

Okedi União Europeia - dinamarquês - EMA (European Medicines Agency)

okedi

laboratorios farmacéuticos rovi, s.a. - risperidone - skizofreni - psykoleptika - treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.

Locametz União Europeia - dinamarquês - EMA (European Medicines Agency)

locametz

novartis europharm limited  - gozetotide - radionuklidbilleddannelse - diagnostiske radioaktive lægemidler - dette lægemiddel er kun til diagnostisk brug. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Cimzia União Europeia - dinamarquês - EMA (European Medicines Agency)

cimzia

ucb pharma sa - certolizumab pegol - crohnsygdom - immunosuppressiva - cimzia, in combination with methotrexate (mtx), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmard) including methotrexate, has been inadequate. cimzia kan gives som monoterapi i tilfælde af intolerance overfor methotrexat eller når fortsatte behandling med methotrexat er upassende. cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.

Revlimid União Europeia - dinamarquês - EMA (European Medicines Agency)

revlimid

bristol-myers squibb pharma eeig - lenalidomid - multiple myeloma; lymphoma, mantle-cell; myelodysplastic syndromes - immunosuppressiva - flere myelomarevlimid som monoterapi er angivet til vedligeholdelse behandling af voksne patienter med nyligt diagnosticeret med myelomatose, som har undergået en autolog stamcelle-transplantation. revlimid som kombinationsbehandling med dexamethason, eller bortezomib og dexamethason, eller melphalan og prednison (se afsnit 4. 2) er indiceret til behandling af voksne patienter med tidligere ubehandlet myelomatose, der ikke er berettiget til transplantation. revlimid i kombination med dexamethason er indiceret til behandling af myelomatose hos voksne patienter, der har modtaget mindst én tidligere behandling. myelodysplastiske syndromesrevlimid som monoterapi er indiceret til behandling af voksne patienter med transfusion er afhængige af anæmi på grund af lav eller intermediær-1 risiko myelodysplastiske syndromer, der er forbundet med en isoleret sletning 5q cytogenetiske abnormitet, når andre behandlingsmuligheder ikke er tilstrækkelige eller utilstrækkelige. mantle celle lymphomarevlimid som monoterapi er indiceret til behandling af voksne patienter med recidiverende eller refraktær mantle celle lymfom. follikulært lymphomarevlimid i kombination med rituximab (anti-cd20-antistof) er indiceret til behandling af voksne patienter med tidligere behandlet follikulært lymfom (klasse 1 – 3a).