United Kingdom - English - HMA (Heads of Medicines Agencies)

ceva santé animale - infectious bronchitis virus 2.8 eid50/dose - oral lyophilisate - chicken broilers, chicken layers - immunologicals

Australia - English - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 58734 - cochlear implant system evaluation application software - the software provides an interface for the programming interface hardware. electrode and implant telemetry is established via this interface. the maestro software is part of the med-el cochlear implant system which is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profound hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition; additionally for partially deaf individuals who obtain benefit from acoustic amplification in the lower frequencies only, and individuals with single-sided deafness (defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear). the software supports the implants and processors in combination with programming interface hardware.

Australia - English - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - the opus receives auditory sound via microphone. it then transfers this to digital signal via speech coding and transmits this to the implanted cochlear implant, which directly stimulates the inner cochlear. the opus 2 audio processor is a part of the med-el cochlear implant system which is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profound hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition; additionally for partially deaf individuals who obtain benefit from acoustic amplification in the lower frequencies only, and also for individuals with single sided deafness which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate impairment in the other ear. the audio processor is intended to pick up signals from the environment and convert them for transmission to the implant via the coil.

Australia - English - Department of Health (Therapeutic Goods Administration)

med-el implant systems australasia pty ltd - 44067 - surgical procedure kit, ent, reusable - the surgical kit consists of a set of reusable surgical instruments and burrs which can be used by the ent surgeons during med-el ci surgery. the tools facilitate the planning and assessment of the ci surgery and the handling of the med-el ci devices.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

imtrade australia pty ltd - alpha-cypermethrin; liquid hydrocarbon - emulsifiable concentrate - alpha-cypermethrin pyrethroid active 100.0 g/l; liquid hydrocarbon solvent other 735.0 g/l - insecticide - apple | apricot | banksia | broccoli | brussels sprouts | cabbage | canola | cauliflower | chinese cabbage | cotton | eucalyptus - aphids - rhopalosiphum spp. | apple weevil | banksia moth - danima banksiae | barley yellow dwarf virus | blackheaded pasture cockchafer | blue oat or pea mite | brown pasture looper | cabbage moth | cabbage white butterfly | cluster caterpillar | common armyworm - mythimna convecta | corn earworm | cotton budworm or bollworm | curculio beetle | cutworm - agrotis spp. | eucalyptus leaf beetle - c. bimaculata | garden or south african vine weevil | green mirid bug | grey cluster bug | helicoverpa spp. | native budworm or bollworm | pasture webworm - hednota spp. | pea weevil | pink or brown cutworm | plague thrips | redlegged earth mite | rough bollworm | rutherglen bug | sorghum midge | southern or barley armyworm | tobacco budworm | tobacco looper or looper caterpillar | tomato grub | vegetable weevil | wingless grasshopper | acrossidius tasmaniae | apple weevil | barley armyworm | barley grub | barley yellow dwarf virus vect | brown cutworm | corn earworm | cotton bollworm | cribrate weevil | curculio beetl

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - recombinant cholera toxin b subunit 1mg; vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated); vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated); vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) - oral suspension - active: recombinant cholera toxin b subunit 1mg vibrio cholerae inaba 48 classical biotype 31250 million organisms (heat inactivated) vibrio cholerae inaba 6973 el tor biotype 31250 million organisms (formalin inactivated) vibrio cholerae ogawa 50 classical biotype 62500 million organisms (equal parts heat inactivated and formalin inactivated) excipient: dibasic sodium phosphate dihydrate monobasic sodium phosphate dihydrate sodium chloride water for injection citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate dihydrate citric acid raspberry flavour 52383 ap0551 saccharin sodium sodium bicarbonate sodium carbonate sodium citrate - active immunisation of adults and children from two years of age, who will be visiting areas with an ongoing or anticipated epidemic or who will be spending an extended period of time in areas in which cholera infection is a risk. the vaccine should be considered for foreign aid workers and others intending to visit or spend an extended period of time in areas endemic or epidemic for cholera.

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - galantamine - prolonged-release capsule, hard - 16 milligram(s) - anticholinesterases; galantamine

Singapore - English - HSA (Health Sciences Authority)

aenon pharmaceuticals sea pte. ltd. - recombinant cholera toxin b subunit (rctb); vibrio cholerae o1 inaba classic strain (heat inactivated); vibrio cholerae o1 inaba el tor strain (formalin inactivated); vibrio cholerae o1 ogawa classic strain (formalin inactivated); vibrio cholerae o1 ogawa classic strain (heat inactivated) - suspension - 1 mg/dose - recombinant cholera toxin b subunit (rctb) 1 mg/dose; vibrio cholerae o1 inaba classic strain (heat inactivated) 31.25 x 10^9 bacteria; vibrio cholerae o1 inaba el tor strain (formalin inactivated) 31.25 x 10^9 bacteria; vibrio cholerae o1 ogawa classic strain (formalin inactivated) 31.25 x 10^9 bacteria; vibrio cholerae o1 ogawa classic strain (heat inactivated) 31.25 x 10^9 bacteria

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - sitagliptin, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - for patients with type 2 diabetes mellitus:janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.janumet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.janumet is indicated as triple combination therapy with a ppar  agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a ppar  agonist.janumet is also indicated as add on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.

European Union - English - EMA (European Medicines Agency)

ge healthcare as - flutemetamol (18f) - radionuclide imaging; alzheimer disease - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.vizamyl is a radiopharmaceutical medicinal product indicated for positron emission tomography (pet) imaging of β amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for alzheimer’s disease (ad) and other causes of cognitive impairment. vizamyl should be used in conjunction with a clinical evaluation.a negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of ad.