Unia Europejska - polski - EMA (European Medicines Agency)

qbiotics netherlands b.v. - tigilanol tiglate - tigilanol tiglate - psy - do leczenia niesprawne, bez przerzutów odległych (które na scenie) podskórnych guzów komórek tucznych znajdujących się na poziomie lub tylnej łokciowego lub stawu skokowego, a niesprawne, pokoje przerzutami skóry masztowe komórki nowotworów u psów.

Unia Europejska - polski - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - guzy stromal żołądkowo-jelitowe - inne leki przeciwnowotworowe, inhibitory białka kinazy - 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.

Unia Europejska - polski - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - infekcje dróg oddechowych - Środki antybakteryjne do stosowania systemowego, - 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.

Unia Europejska - polski - EMA (European Medicines Agency)

orchard therapeutics (netherlands) bv - atidarsagene autotemcel - leukodystrophy, metachromatic - inne leki na układ nerwowy - 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.

Unia Europejska - polski - 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 - wieprzowy - 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 - polski - EMA (European Medicines Agency)

mylan ireland limited - octan abirateronu - nowotwory stercza - 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 - polski - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - stwardnienie rozsiane, Рецидивно-znika - leki immunosupresyjne - 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 - polski - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - guzy stromal żołądkowo-jelitowe - Środki przeciwnowotworowe - 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 - polski - EMA (European Medicines Agency)

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - Środki przeciwwirusowe do użytku ogólnoustrojowego - 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.

Polska - polski - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

solinea sp. z o.o. sp.k. - chlorhexidini dihydrochloridum + benzocainum - tabletki do ssania - 5 mg + 1,5 mg