Ireland - English - HPRA (Health Products Regulatory Authority)

drehm pharma gmbh - epoprostenol - pdr+solv for soln for inf - 500 microgram

Ireland - English - HPRA (Health Products Regulatory Authority)

drehm pharma gmbh - epoprostenol - pdr+solv for soln for inf - 1.5 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

drehm pharma gmbh - epoprostenol - pdr+solv for soln for inf - 500 microgram

Ireland - English - HPRA (Health Products Regulatory Authority)

drehm pharma gmbh - epoprostenol - pdr+solv for soln for inf - 1.5 milligram

European Union - English - EMA (European Medicines Agency)

pharmaand gmbh - darifenacin hydrobromide - urinary incontinence, urge; urinary bladder, overactive - urologicals, drugs for urinary frequency and incontinence - symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.

Malta - English - Medicines Authority

koanaa healthcare gmbh fehrgasse 7, 2401, fischamend,, austria - pemetrexed - concentrate for solution for infusion - pemetrexed 100 mg - antineoplastic agents

Malta - English - Medicines Authority

koanaa healthcare gmbh fehrgasse 7, 2401, fischamend,, austria - pemetrexed - powder for concentrate for solution for infusion - pemetrexed 500 mg - antineoplastic agents

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.

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.

Ireland - English - HPRA (Health Products Regulatory Authority)

koanaa healthcare limited - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - 20 milligram(s)/millilitre - other antineoplastic agents; irinotecan