Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - idarubicin hydrochloride - solution for injection - idarubicin hydrochloride 1 mg/ml - antineoplastic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - idarubicin hydrochloride 1 mg/ml;   - solution for injection - 1 mg/ml - active: idarubicin hydrochloride 1 mg/ml   excipient: glycerol hydrochloric acid sodium hydroxide water for injection - idarubicin ebewe is indicated for use in acute myelogenous leukaemia (aml) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. idarubicin ebewe may be used in combination chemotherapy regimens involving other cytotoxic agents.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - idarubicin hydrochloride -

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - idarubicin hydrochloride, quantity: 1 mg/ml - injection, solution - excipient ingredients: glycerol; hydrochloric acid; water for injections - zavedos is indicated for use in acute myelogenous leukaemia (aml) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. zavedos capsules are indicated whenever the intravenous route is not considered suitable. zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - idarubicin hydrochloride, quantity: 1 mg/ml - injection, solution - excipient ingredients: glycerol; hydrochloric acid; water for injections - zavedos is indicated for use in acute myelogenous leukaemia (aml) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. zavedos capsules are indicated whenever the intravenous route is not considered suitable. zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer (perth) pty ltd - idarubicin hydrochloride, quantity: 1 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; glycerol; water for injections - belgium adults: zavedos is indicated in cases of blood cancer called acute myelogenous leukemia (aml) to induce remission, as a first-line treatment or in patients with relapse or a relapsing form of the disease. zavedos is indicated in adults suffering from a blood cancer called acute lymphoblastic leukemia (all) that has been previously treated. children: zavedos, in combination with cytarabine, is indicated as the first induction therapy for remission in children suffering from a blood cancer called acute myeloblastic leukemia (aml), previously untreated. zavedos is also indicated in children with a blood cancer called acute lymphoblastic leukemia (all) that has been previously treated. canada idamycin pfs (idarubicin hydrochloride injection) alone or in combination chemotherapy regimens involving other cytotoxic agents is indicated in: ? acute non-lymphocytic leukemia (anll); in adults for remission induction as front-line therapy or for remission induction in relapsed or refractory patients. ? acute lymphocytic leukemia (all) as second line treatment in adults and children. chile ? acute non-lymphocytic leukemia (anll); also called acute myelogenous leukemia (aml) in children and adults for remission induction as first-line therapy or for remission induction in relapsed or refractory patients. ? acute lymphocytic leukemia (all) as second-line treatment in adults and children. colombia adjunct in the treatment of acute myelogenous leukemia (aml) in adults and second line treatment for acute lymphocytic leukemia (all) in adults and children. ecuador acute non-lymphocytic leukemia (anll; also referred to as acute myelogenous leukemia [aml]) in adults for remission induction as first-line therapy or for remission induction in relapsed or refractory patients. acute lymphocytic leukemia (all) as second-line treatment in adults and children. finland zavedos is used for the treatment of acute myeloid leukaemia (a type of blood cancer) in adults. zavedos, in combination with cytarabin, is indicated for the first remission induction treatment in previously not treated children with acute mylogenous leukaemia (aml). france zavedos solution for infusion is indicated for the treatment of acute myeloid leukemia. zavedos solution for infusion is indicated for the treatment of acute lymphoblastic leukemia in relapse. zavedos solution for infusion in combination with cytarabine, is indicated for the induction treatment of first remission in previously untreated children with blood cancer called acute myeloid leukemia (aml). germany adults zavedos is indicated for use in combination with other cytostatics (such as cytabarine) for the treatment (remission induction and consolidation) of adult patients with acute myeloid leukaemia (aml, anll) who have not received any previous treatment. children and adolescents zavedos, in combination with cytarabine, is indicated for first-line remission induction treatment of children with blood cancer, called acute myeloid leukaemia (aml), who have not received any previous treatment. italy zavedos is used: ? in adults and children as treatment for acute myeloid leukaemia, a blood cancer; ? in adults and children as treatment for acute lymphocytic leukaemia, a blood cancer, when previous treatments did not work or were inadequate. malaysia acute non-lymphocytic leukemia (anll) in adults for remission induction in untreated patients, or for remission induction in relapsed or refractory patients, acute lymphocytic leukemia (all) as second line treatment in adults and children. netherlands adults acute myeloblastic leukaemia (aml): for remission induction as first line treatment or for remission induction in relapsed or refractory patients. acute lymphoblastic leukaemia (all): second line treatment. children acute myeloblastic leukaemia (aml): for remission induction as first line treatment, in combination with cytarabine. acute lymphoblastic leukaemia (all): second line treatment. poland adults: - acute non-lymphocytic leukemia [anll, also referred to as acute myelogenous leukemia (aml)] for remission induction as first-line therapy or for remission induction in relapsed or refractory patients. - acute lymphocytic leukemia (all) as second line treatment. children: - acute myeloid leukemia (aml) in combination with cytarabine, as first line therapy for remission induction. - acute lymphocytic leukemia (all) as second line treatment. singapore zavedos is indicated for use in acute myelogenous leukaemia (aml) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents. slovak republic use in adults: acute myeloblastic leukemia (aml) for induction of remission (induction mitigation until disappearance of disease symptoms): - in the first line of aml treatment, - in patients with aml relapse (aggravation or development of previous status), - for non-responding amls, - acute lymphoblastic leukemia (all) as a second-line treatment. use in children: - acute myeloblastic leukemia (aml) for induction of remission in combination with cytarabine as the first line of treatment, - acute lymphoblastic leukemia (all) as a second-line treatment. switzerland acute myeloid leukaemia in combination with other cytostatics. acute lymphatic leukaemia as reserve medication in combination with other cytostatics. thailand zavedos is indicated for use in acute myelogenous leukaemia (aml) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents. united kingdom adults for the treatment of acute myeloid leukaemia (aml), for remission induction in untreated patients or for remission induction in relapsed or refractory patients. for second line treatment of relapsed acute lymphoblastic leukaemia (all). paediatric population for first line treatment of acute myeloid-leukaemia (aml), in combination with cytarabine, for remission induction. for second line treatment of relapsed acute lymphoblastic leukaemia (all). zavedos may be used in combination chemotherapy regimens involving other cytotoxic agents

Canada - English - Health Canada

pfizer canada ulc - idarubicin hydrochloride - solution - 1mg - idarubicin hydrochloride 1mg - antineoplastic agents

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

accord-uk ltd - idarubicin hydrochloride - solution for injection - 1mg/1ml

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

accord-uk ltd - idarubicin hydrochloride - solution for injection - 1mg/1ml

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - idarubicin hydrochloride 1 mg/ml - solution for injection - 5 mg/5 ml - idarubicin hydrochloride 1 mg/ml - idarubicin