Filipīnas - angļu - FDA (Food And Drug Administration)

jvzea pharmaceuticals, inc. - cefuroxime (as axetil) - powder for suspension - 250 mg/5 ml

Filipīnas - angļu - FDA (Food And Drug Administration)

jvzea pharmaceuticals, inc. - cetirizine (as dihydrochloride) - tablet - 10mg

Filipīnas - angļu - FDA (Food And Drug Administration)

jvzea pharmaceuticals, inc. - cetirizine dihydrochloride - syrup - 5 mg/5 ml

Filipīnas - angļu - FDA (Food And Drug Administration)

endurance healthcare ltd.; importer: ambica international corporation; distributor: jvzea pharmaceuticals inc. - omeprazole - delayed-release capsule - 20mg

Filipīnas - angļu - FDA (Food And Drug Administration)

n/a; importer: ambica international corporation; distributor: jvzea pharmaceuticals inc. - omeprazole - delayed release capsule - 40 mg

Filipīnas - angļu - FDA (Food And Drug Administration)

n/a; importer: ambica international corporation; distributor: jvzea pharmaceuticals inc. - cetirizine hydrochloride - tablet - 10 mg

Malaizija - angļu - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

tj-tyt pharmaceuticals (m) sdn. bhd. - semen raphanus sativus l.; rhizoma atractylodes lancea; pericarpium citri reticulatae; herba agastache rugosa; herba mentha haplocalyx; radix glycyrrhiza glabra; rhizoma corydalis turtschaninovii; herba artemisia scoparia; semen areca catechu; rhizoma alisma orientale juzep.; rhizoma cyperus rotandus -

Eiropas Savienība - angļu - 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.

Īrija - angļu - HPRA (Health Products Regulatory Authority)

ferndale pharmaceuticals ltd - lidocaine - cream - 40 milligram(s)/gram - anesthetics for topical use; lidocaine - anaesthetics for topical use, lidocaine - local anaesthetic for topical use to produce surface anaesthesia of the skin prior to: - venous cannulation or venipuncture in adults and in the paediatric population
one month - administration of painful topical treatments on larger surface areas of intact skin where use of a topical anaesthetic is appropriate in adults only.

Lielbritānija - angļu - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - cilostazol - oral tablet - 100mg