Uniunea Europeană - croată - 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.

Uniunea Europeană - croată - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - multipla skleroza, Рецидивно-Ремиттирующее - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

Uniunea Europeană - croată - 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.

Uniunea Europeană - croată - 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).

Uniunea Europeană - croată - 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.

Uniunea Europeană - croată - 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.

Uniunea Europeană - croată - EMA (European Medicines Agency)

amivas ireland ltd - artesunate - malarija - antiprotozoals - artesunate amivas is indicated for the initial treatment of severe malaria in adults and children. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje противомалярийных posrednika.

Uniunea Europeană - croată - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - maribavir - infekcije citomegalovirusa - antivirusni lijekovi za sustavnu uporabu - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antivirusnih lijekova.

Uniunea Europeană - croată - EMA (European Medicines Agency)

takeda gmbh - dengue virus, serotype 2, expressing dengue virus, serotype 1, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 3, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 4, surface proteins, live, attenuated, dengue virus, serotype 2, live, attenuated - denga - cjepiva - qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. the use of qdenga should be in accordance with official recommendations.

Uniunea Europeană - croată - 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.