Európai Unió - magyar - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol acetate, mometasone furoate - asztma - gyógyszerek obstruktív légúti betegségek, - atectura breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Európai Unió - magyar - EMA (European Medicines Agency)

vetoquinol - tulathromycint - baktériumellenes szerek szisztémás alkalmazásra - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. a betegség jelenlétét az állományban metafilaktikus kezelés előtt meg kell állapítani. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. a betegség jelenlétét az állományban metafilaktikus kezelés előtt meg kell állapítani. the product should only be used if pigs are expected to develop the disease within 2–3 days. bárány: a kezelés a korai stádiumban fertőző pododermatitis (láb rothadás) kapcsolódó fertőző dichelobacter nodosus igénylő szisztémás kezelés.

Európai Unió - magyar - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - daganatellenes szerek - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Európai Unió - magyar - EMA (European Medicines Agency)

pinax pharma gmbh - az ioflupán (123i) - radionuclide imaging; dementia; movement disorders - diagnosztikai radiofarmakonok - ez a gyógyszer csak diagnosztikai célra használható. celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy.  celsunax is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy. felnőtt betegeknél, segít megkülönböztetni valószínű demencia a lewy-testek alzheimer-kór.  celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

Európai Unió - magyar - EMA (European Medicines Agency)

zoetis belgium - inactivated mycoplasma hyopneumoniae, strain p-5722-3, inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2a open reading frame 2 (orf2) protein, inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2b orf2 protein - immunológiai készítmények suidae számára - sertések (hizlaló) - active immunisation of pigs against porcine circovirus type 2 to reduce viral load in blood and lymphoid tissues, fecal shedding and the lesions in lymphoid tissues associated with pcv2 infection. protection was demonstrated against porcine circovirus types 2a, 2b and 2d. active immunisation of pigs against mycoplasma hyopneumoniae to reduce the lung lesions associated with mycoplasma hyopneumoniae infection.  onset of immunity (both vaccination schedules): 3 weeks after (the last) vaccination.  duration of immunity (both vaccination schedules): 23 weeks after (the last) vaccination.  in addition, vaccination has been shown to reduce body weight gain losses under field conditions.

Európai Unió - magyar - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - kutyák - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

Európai Unió - magyar - EMA (European Medicines Agency)

valneva austria gmbh - covid-19 vaccine (inactivated, adjuvanted, adsorbed) - covid-19 virus infection - a vakcinák - covid-19 vaccine (inactivated, adjuvanted) valneva is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 to 50 years of age.  the use of this vaccine should be in accordance with official recommendations.

Európai Unió - magyar - EMA (European Medicines Agency)

billev pharma aps - lutetium (177lu) chloride - radionuklid képalkotás - terápiás radiofarmakonok - lutetium (177lu) chloride billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

Európai Unió - magyar - EMA (European Medicines Agency)

sanofi b.v. - sutimlimab - hemolysis; anemia, hemolytic, autoimmune - immunszuppresszánsok - enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (cad).

Európai Unió - magyar - EMA (European Medicines Agency)

janssen-cilag international n.v. - talquetamab - myeloma multiplex - daganatellenes szerek - talvey is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti cd38 antibody and have demonstrated disease progression on the last therapy.