Европска Унија - Енглески - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord 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-pdgfrα rearrangement.- adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.- 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 treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined.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 dfsp. 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.  

Европска Унија - Енглески - EMA (European Medicines Agency)

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , 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;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult 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-pdgfr rearrangement;, 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. , the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib actavis is indicated for: , 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 dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited. there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Европска Унија - Енглески - EMA (European Medicines Agency)

medac - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; leukemia, myelogenous, chronic, bcr-abl positive; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome - protein kinase inhibitors - imatinib medac is indicated for the treatment of: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;paediatric patients with ph+cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase;adult and paediatric patients with ph+cml in 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;adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery.the effect of imatinib on the outcome of bone marrow transplantation has not been determined.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 dfsp.the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited. except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Европска Унија - Енглески - 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. 

Ирска - Енглески - HPRA (Health Products Regulatory Authority)

laboratorios leon farma, s.a. - etonogestrel; ethinylestradiol ph.eur. - vaginal delivery system - 0.120/0.015 milligram(s) - intravaginal contraceptives; vaginal ring with progestogen and estrogen

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - ponatinib hydrochloride, quantity: 48.1 mg (equivalent: ponatinib, qty 45 mg) - tablet, film coated - excipient ingredients: magnesium stearate; sodium starch glycollate; lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - iclusig is indicated for the treatment of adult patients with:,chronic phase (cp), accelerated phase (ap), or blast phase (bp) chronic myeloid ieukaemia (cml) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a t315i mutation.,philadelphia chromosome positive acute lymphoblastic ieukaemia (ph+ all) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a t315i mutation.,therapy with iclusig should be initiated and monitored by a haematologist with expertise in managing adult ieukaemias.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - ponatinib hydrochloride, quantity: 16 mg (equivalent: ponatinib, qty 15 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - iclusig is indicated for the treatment of adult patients with:,chronic phase (cp), accelerated phase (ap), or blast phase (bp) chronic myeloid ieukaemia (cml) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a t315i mutation.,philadelphia chromosome positive acute lymphoblastic ieukaemia (ph+ all) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a t315i mutation.,therapy with iclusig should be initiated and monitored by a haematologist with expertise in managing adult ieukaemias.

Ирска - Енглески - HPRA (Health Products Regulatory Authority)

tiofarma b.v. - colchicine ph. eur. - tablet - 500 microgram(s) - preparations with no effect on uric acid metabolism; colchicine

Ирска - Енглески - HPRA (Health Products Regulatory Authority)

tiofarma b.v. - colchicine ph. eur. - tablet - 1000 microgram(s) - preparations with no effect on uric acid metabolism; colchicine

Ирска - Енглески - HPRA (Health Products Regulatory Authority)

accord healthcare limited - olmesartan medoxomil; amlodipine (as amlodipine besilate ph. eur.) - film-coated tablet - 20/5 mg/mg - angiotensin ii antagonists and calcium channel blockers; olmesartan medoxomil and amlodipine