European Union - English - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib teva is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr‑abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment.adult and paediatric patients with ph+ cml in chronic phase after failure of interferon‑alpha therapy, or in accelerated phase or blast crisis.adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy.adult patients with relapsed or refractory ph+ all as monotherapy.adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements.adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.imatinib teva is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatment.the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases. 

European Union - English - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastic agents - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment.adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy.adult patients with relapsed or refractory ph+ all as monotherapy.adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements.adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatment.the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - cx-024414 mrna -

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - abacavir as sulfate; lamivudine - film coated tablets - abacavir as sulfate 600 mg; lamivudine 300 mg - nucleoside and nucleotide reverse transcriptase inhibitors - kivexa is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection in adults, adolescents and children weighing at least 25 kg.

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - etravirine - hiv infections - non-nucleoside reverse transcriptase inhibitors, antivirals for systemic use - intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (hiv-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.this indication is based on week-48 analyses from two phase-iii trials in highly pretreated patients where intelence was investigated in combination with an optimised background regimen (obr) which included darunavir/ritonavir. the indication in paediatric patients is based on 48-week analyses of a single-arm, phase-ii trial in antiretroviral-treatment-experienced paediatric patients.

Israel - English - Ministry of Health

rafa laboratories ltd - budesonide - tablets orodispersible - budesonide 0.5 mg - budesonide - treatment of eosinophilic esophagitis (eoe) in adults.

Israel - English - Ministry of Health

rafa laboratories ltd - budesonide - tablets orodispersible - budesonide 1 mg - budesonide - treatment of eosinophilic esophagitis (eoe) in adults.

European Union - English - EMA (European Medicines Agency)

dr. falk pharma gmbh - budesonide - esophageal diseases - antidiarrheals, intestinal antiinflammatory / antiinfective agents - jorveza is indicated for the treatment of eosinophilic esophagitis (eoe) in adults (older than 18 years of age).

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

dr falk pharma australia pty ltd - budesonide, quantity: 1 mg - tablet, orally disintegrating - excipient ingredients: magnesium stearate; mannitol; macrogol 6000; sodium acid citrate; sodium dihydrogen citrate; sodium bicarbonate; sucralose; povidone; docusate sodium - jorveza is indicated for the treatment of eosinophilic esophagitis (eoe) in adults

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

dr falk pharma australia pty ltd - budesonide, quantity: 0.5 mg - tablet, orally disintegrating - excipient ingredients: magnesium stearate; mannitol; macrogol 6000; sodium acid citrate; sodium dihydrogen citrate; sodium bicarbonate; sucralose; povidone; docusate sodium - jorveza? is indicated for the treatment of eosinophilic oesophagitis (eoe) in adults.