União Europeia - português - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - macimorelin acetato de - técnicas de diagnóstico, endócrino - macimorelin - este medicamento é apenas para uso diagnóstico.  ghryvelin is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

accord farmacÊutica ltda - cloridrato de topotecana - antineoplasico

Brasil - português - ANVISA (Agência Nacional de Vigilância Sanitária)

biolab sanus farmacÊutica ltda - nitrosureias alquilantes

União Europeia - português - EMA (European Medicines Agency)

qbiotics netherlands b.v. - tigilanol tiglate - tigilanol tiglate - cães - para o tratamento de não-resectable, não-metastático (que de preparo) subcutâneo mastócitos tumores localizados em ou distal para o cotovelo ou o jarrete, e não resectable, não de metástase cutânea mastócitos tumores em cães.

União Europeia - português - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - tumores do estromal gastrointestinal - outros agentes antineoplásicos, inibidores de proteína quinase - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

União Europeia - português - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - infecções respiratórias - antibacterianos para uso sistémico, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.

União Europeia - português - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - outros medicamentos do sistema nervoso - libmeldy is indicated for the treatment of metachromatic leukodystrophy (mld) characterized by biallelic mutations in the arysulfatase a (arsa) gene leading to a reduction of the arsa enzymatic activity:in children with late infantile or early juvenile forms, without clinical manifestations of the disease,in children with the early juvenile form, with early clinical manifestations of the disease, who still  have the ability to walk independently and before the onset of cognitive decline.

União Europeia - português - 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 - porcos - 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.

União Europeia - português - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - esclerose múltipla remitente-recorrente envio - imunossupressores - 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).

União Europeia - português - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - tumores do estromal gastrointestinal - agentes antineoplásicos - 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.