Unia Europejska - chorwacki - 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 - svinje - 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.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

mylan ireland limited - abirateron acetat - prostatske neoplazme - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - multipla skleroza, Рецидивно-Ремиттирующее - imunosupresivi - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5. 1 for important information on the populations for which efficacy has been established).

Unia Europejska - chorwacki - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - tumori gastrointestinalnog stroma - antineoplastična sredstva - 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.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirusni lijekovi za sustavnu uporabu - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 i 5. tecovirimat siga should be used in accordance with official recommendations.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

astrazeneca ab - anifrolumab - lupus erythematosus, sistemski - imunosupresivi - saphnelo is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (sle), despite standard therapy.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - agenti imaju antikancerogena - lytgobi monotherapy is indicated for the treatment of adult patients 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.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - respiratory syncytial virus recombinant glycoprotein f stabilised in the pre-fusion conformation (rsvpref3) produced in chinese hamster ovary (cho) cells by recombinant dna technology - infekcije respiratornih sincicijskih virusa - cjepiva - arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (lrtd) caused by respiratory syncytial virus in adults 60 years of age and older. korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - cedazuridine, decitabine - leukemija, mieloid - antineoplastična sredstva - inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for standard induction chemotherapy.