Cabazitaxel Accord الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

cabazitaxel accord

accord healthcare s.l.u. - cabazitaxel - prostatic neoplasms, castration-resistant - antineoplastic agents - treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Ibandronic acid Accord الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

ibandronic acid accord

accord healthcare s.l.u. - ibandronic acid - wounds and injuries; breast diseases; neoplastic processes; calcium metabolism disorders; water-electrolyte imbalance - drugs for treatment of bone diseases - ibandronic acid is indicated in adults forprevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.treatment of tumour induced hypercalcaemia with or without metastases.treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).a reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

Levetiracetam Accord الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

levetiracetam accord

accord healthcare s.l.u. - levetiracetam - epilepsy - antiepileptics, - levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.levetiracetam is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Temozolomide Accord الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

temozolomide accord

accord healthcare s.l.u. - temozolomide - glioma; glioblastoma - antineoplastic agents - for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (rt) and subsequently as monotherapy treatment.for the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Dabigatran Etexilate Accord الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

dabigatran etexilate accord

accord healthcare s.l.u. - dabigatran etexilate mesilate - venous thromboembolism; arthroplasty, replacement - antithrombotic agents - prevention of venous thromboembolic events

Arsenic trioxide Accord الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

arsenic trioxide accord

accord healthcare s.l.u. - arsenic trioxide - leukemia, promyelocytic, acute - antineoplastic agents - arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (apl) (white blood cell count, ≤ 10 x 103/μl) in combination with all-trans-retinoic acid (atra)relapsed/refractory acute promyelocytic leukaemia (apl)(previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (pml/rar-alpha) gene.the response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Dexmedetomidine Accord الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

dexmedetomidine accord

accord healthcare s.l.u. - dexmedetomidine - premedication - psycholeptics - for sedation of adult icu (intensive care unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to richmond agitation-sedation scale (rass) 0 to -3).for sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.

Tolvaptan Accord الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

tolvaptan accord

accord healthcare s.l.u. - tolvaptan - inappropriate adh syndrome - diuretics, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).