Uniunea Europeană - cehă - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - další léky na nervový systém - 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.

Uniunea Europeană - cehă - 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 - prasata - 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 - cehă - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - roztroušená skleróza, relaps-remitentní - imunosupresiva - 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 - cehă - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinální stromální nádory - antineoplastická činidla - 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 - cehă - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirotika pro systémové použití - 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 a 5. tecovirimat siga should be used in accordance with official recommendations.

Uniunea Europeană - cehă - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - voclosporin - lupus nephritis - imunosupresiva - lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class iii, iv or v (including mixed class iii/v and iv/v) lupus nephritis (ln).

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

curium netherlands b.v., petten array - 4847 gallium-(67ga)-citrÁt - injekční roztok - 37mbq/ml - gallium-(67ga)-citrÁt

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

curium netherlands b.v., petten nizozemsko - 12801 natrium-jodhippurÁt-(123i); 11856 kyselina jodhippurovÁ - injekční roztok - 37mbq/ml - natrium-jodhippurÁt-(123i)

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

curium netherlands b.v., petten array - 12972 chlorid inditÝ-(111in) - prekurzor radiofarmaka, roztok - 370mbq/ml - slouČeniny india-(111in)

Republica Cehă - cehă - SUKL (Státní ústav pro kontrolu léčiv)

curium netherlands b.v., petten array - 13441 indium-(111in)-oxin - prekurzor radiofarmaka, roztok - 37mbq/ml - komplex india-(111in) s oxinem, pro znaČenÍ bunĚk