Austrálie - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

dasco proprietary limited - iodine; glycerol - topical solution/suspension - iodine mineral-iodine active 20.0 g/l; glycerol solvent active 58.6 g/l - dermatological preps. - dairy cattle | bovine | breeders | calves | dairy cow | growers | lactating cow | milking cow - mastitis | subclinical mastitis

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

reckitt benckiser (new zealand) limited - codeine phosphate hemihydrate 6mg;  ;  ;  ;  ;  ;  ; paracetamol 500mg (as part of a proprietary blend with 56 mg rhodapap dc-90 ultra fine); phenylephrine hydrochloride 5mg;   - tablet - active: codeine phosphate hemihydrate 6mg             paracetamol 500mg (as part of a proprietary blend with 56 mg rhodapap dc-90 ultra fine) phenylephrine hydrochloride 5mg   excipient: crospovidone magnesium stearate microcrystalline cellulose paracetamol/acetaminophen dc-90 as part of a propriety blend with with 56 mg rhodapap dc-90 ultra fine - relief of the symptoms of cold & flu

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - paracetamol 500mg (compap l coarse; proprietary info. mallinckrodt tt60-59-7-2) - tablet - 500 mg - active: paracetamol 500mg (compap l coarse; proprietary info. mallinckrodt tt60-59-7-2)

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

glob limited - cefuroxime - tablets - 125 milligram

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

glob limited - cefuroxime - tablets - 250 milligram

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

glob limited - cefuroxime - tablets - 500 milligram

Evropská unie - angličtina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - atazanavir (as sulfate) - hiv infections - antivirals for systemic use - atazanavir mylan, co-administered with low dose ritonavir, is indicated for the treatment of hiv 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 pi mutations). there are very limited data available from children aged 6 to less than 18 years.the choice of atazanavir mylan in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Evropská unie - 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.,

Austrálie - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

aaron laboratories proprietary limited - bioallethrin; d-phenothrin; tetramethrin 20:80 - aerosol - bioallethrin pyrethroid active 1.19 g/kg; d-phenothrin pyrethroid active 1.5 g/kg; tetramethrin 20:80 pyrethroid active 3.82 g/kg - household insecticide

Austrálie - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

dasco proprietary limited - potassium hydroxide; sodium hydroxide - soluble concentrate - potassium hydroxide mineral-potassium-base active 125.0 g/l; sodium hydroxide mineral-sodium-base active 375.0 g/l - dairy cleanser