Izrael - angličtina - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. * adult patients with relapsed or refractory ph + all as monotherapy. * adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration for chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation. * adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

athlone laboratories ltd - amlodipine (as amlodipine besilate ph. eur.) - tablet - 5 milligram(s) - dihydropyridine derivatives; amlodipine

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

athlone laboratories ltd - amlodipine (as amlodipine besilate ph. eur.) - tablet - 10 milligram(s) - dihydropyridine derivatives; amlodipine

Singapur - angličtina - HSA (Health Sciences Authority)

zuellig pharma pte ltd - omeprazole - capsule - 20mg - omeprazole 20mg

Malta - angličtina - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - omeprazole - gastro-resistant hard capsule - omeprazole 10 mg - drugs for acid related disorders

Malta - angličtina - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - omeprazole - gastro-resistant hard capsule - omeprazole 20 mg - drugs for acid related disorders

Malta - angličtina - Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - omeprazole - gastro-resistant hard capsule - omeprazole 40 mg - drugs for acid related disorders

Európska únia - angličtina - EMA (European Medicines Agency)

pfizer europe ma eeig - bosutinib (as monohydrate) - leukemia, myeloid - antineoplastic agents, protein kinase inhibitors - bosulif is indicated for the treatment of adult patients with:newly‑diagnosed chronic phase (cp) philadelphia chromosome-positive chronic myelogenous leukaemia (ph+ cml).cp, accelerated phase (ap), and blast phase (bp) ph+ cml previously treated with one or more tyrosine kinase inhibitor(s) [tki(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

Európska únia - angličtina - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastic agents - glivec is indicated for the treatment of , adult 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-pdgfra rearrangement. , the effect of glivec on the outcome of bone-marrow transplantation has not been determined. glivec is indicated for: , the 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 glivec 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 glivec 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.,

Európska únia - angličtina - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.see sections 4.2 assessment of cardiovascular status prior to start of therapy and 4.4 situations where an alternative treatment may be considered.