Európai Unió - bolgár - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - Кистозна фиброза - Други продукти на дихателната система - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Európai Unió - bolgár - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - Стомашно-чревни стромални тумори - Антинеопластични средства - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

Európai Unió - bolgár - EMA (European Medicines Agency)

astrazeneca ab - selumetinib sulfate - neurofibromatosis 1 - Антинеопластични средства - koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (pn) in paediatric patients with neurofibromatosis type 1 (nf1) aged 3 years and above.

Európai Unió - bolgár - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - live recombinant marek’s disease (md) virus, serotype 1, strain rn1250 - Имунологични за аве - Пиле - for active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by marek’s disease (md) virus (including very virulent md virus).

Európai Unió - bolgár - EMA (European Medicines Agency)

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - Прасета - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Európai Unió - bolgár - EMA (European Medicines Agency)

ceva-phylaxia co. ltd. - recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus, live - Пиле - for active immunisation of chickens from 8 weeks of age in order to reduce the skin lesions due to fowlpox and to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis.

Európai Unió - bolgár - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - attenuated feline rhinotracheitis herpesvirus (fhv f2 strain), inactivated feline calicivirosis antigens (fcv 431 and g1 strains), attenuated feline panleucopenia virus (pli iv), felv recombinant canarypox virus (vcp97), attenuated chlamydophila felis (905 strain) - Имуномодулатори за котки,на - Котки - active immunisation of cats aged 8 weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs;against chlamydophila felis infection to reduce clinical signs;against feline panleucopenia to prevent mortality and clinical signs;against leukaemia to prevent persistent viraemia and clinical signs of the related disease. onsets of immunity are 1 week after primary vaccination course for rhinotracheitis, calicivirus, chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component. the duration of immunity is one year after the last re-vaccination for the chlamydiosis and feline leukaemia components, and one year after primary vaccination course and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.

Európai Unió - bolgár - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - attenuated feline rhinotracheitis herpesvirus (fhv f2 strain), inactivated feline calicivirosis antigens (fcv 431 and g1 strains), attenuated chlamydophila felis (905 strain), attenuated feline panleucopenia virus (pli iv) - Имуномодулатори за котки,на - Котки - active immunisation of cats aged eight weeks and older:• against feline viral rhinotracheitis to reduce clinical signs;• against calicivirus infection to reduce clinical signs;• against chlamydophila felis infection to reduce clinical signs;• against feline panleucopenia to prevent mortality and clinical signs. Нарушенията на имунитета са демонстрирани една седмица след основния ваксинационен курс за ринотрахеит, калицивирус, компоненти на chlamydophila felis и панлевкопения. the duration of immunity is one year after the last re-vaccination for the chlamydiosis component, and oneyear after primary vaccination and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.

Európai Unió - bolgár - EMA (European Medicines Agency)

mylan ireland limited - финголимод хидрохлорид - Множествена Склероза, Рецидивно-Ремиттирующее - Имуносупресори - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 и 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Európai Unió - bolgár - EMA (European Medicines Agency)

virbac s.a. - рекомбинантен омега интерферон от котешки произход - Иммуностимуляторы, - dogs; cats - dogsreduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age. catstreatment of cats infected with feline leukaemia virus (felv) and / or feline immunodeficiency virus (fiv), in non-terminal clinical stages, from the age of nine weeks. in a field study conducted, it was observed that there was:a reduction of clinical signs during the symptomatic phase (four months);a reduction of mortality:in anaemic cats, mortality rate of about 60% at four, six, nine and 12 months was reduced by approximately 30% following treatment with interferon;in non-anaemic cats, mortality rate of 50% in cats infected by felv was reduced by 20% following treatment with interferon. При котки, заразени с fiv, смъртността е ниска (5%) и не е повлияна от лечението.