Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - pantoprazole sodium sesquihydrate - tablets gastro-resistant - 20 milligram - proton pump inhibitors

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - pantoprazole sodium sesquihydrate - tablets gastro-resistant - 40 milligram - proton pump inhibitors

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - quetiapine - prolonged-release tablet - 50 milligram(s) - diazepines, oxazepines, thiazepines and oxepines; quetiapine

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - voriconazole - powder for solution for infusion - 200 milligram(s) - triazole derivatives; voriconazole

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - imatinib mesilate - film-coated tablet - 100 milligram(s) - protein kinase inhibitors; imatinib - protein-tyrosine kinase inhibitor - 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 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-pdgfr
rearrangement. adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurre

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - imatinib mesilate - film-coated tablet - 400 milligram(s) - protein kinase inhibitors; imatinib - protein-tyrosine kinase inhibitor - 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 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-pdgfr
rearrangement. adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurre

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - lamivudine; abacavir - film-coated tablet - 600 mg/300 milligram(s)

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - amlodipine; valsartan - film-coated tablet - 5mg/80 milligram(s) - angiotensin ii antagonists and calcium channel blockers; valsartan and amlodipine

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - amlodipine; valsartan - film-coated tablet - 5mg/160 milligram(s) - angiotensin ii antagonists and calcium channel blockers; valsartan and amlodipine

Irland - engelsk - HPRA (Health Products Regulatory Authority)

rowex ltd - amlodipine; valsartan - film-coated tablet - 10mg/160 milligram(s) - angiotensin ii antagonists and calcium channel blockers; valsartan and amlodipine