Европейски съюз - чешки - EMA (European Medicines Agency)

novartis europharm limited  - siponimod kyselina fumarová - roztroušená skleróza, relaps-remitentní - selektivní imunosupresiva - mayzent je indikován k léčbě dospělých pacientů se sekundární progresivní roztroušenou sklerózou (spms) s aktivní onemocnění, svědčí relapsů nebo zobrazovací funkce zánětlivé aktivity.

Европейски съюз - чешки - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol acetate, mometasone furoate - astma - léky na obstrukční onemocnění dýchacích cest, - atectura breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Европейски съюз - чешки - EMA (European Medicines Agency)

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - antineoplastická činidla - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma. phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults. phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

Европейски съюз - чешки - 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.

Европейски съюз - чешки - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - inzulin aspart - diabetes mellitus - léky užívané při diabetu - kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Европейски съюз - чешки - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - eprinomectin, esafoxolaner, praziquantel - eprinomectin, combinations, , avermectins, antiparasitic products, insecticides and repellents - kočky - for cats with, or at risk from mixed infections by cestodes, nematodes and ectoparasites. veterinární léčivý přípravek je výhradně indikována, když všechny tři skupiny jsou zaměřeny na stejnou dobu.

Европейски съюз - чешки - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - elivaldogene autotemcel - adrenoleukodystrophy - další léky na nervový systém - treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an abcd1 genetic mutation, and for whom a human leukocyte antigen (hla) matched sibling haematopoietic stem cell donor is not available.

Европейски съюз - чешки - EMA (European Medicines Agency)

elanco gmbh - lotilaner, milbemycin oxime - endectocides - psi - for use in dogs with, or at risk from, mixed infestations/infections of ticks, fleas, gastrointestinal nematodes, heartworm and/or lungworm.

Европейски съюз - чешки - EMA (European Medicines Agency)

laboratorios farmacéuticos rovi, s.a. - risperidone - schizofrenie - psycholeptika - treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.

Европейски съюз - чешки - EMA (European Medicines Agency)

pfizer europe ma eeig  - rimegepant - poruchy migrény - antimigraine preparations, calcitonin gene-related peptide (cgrp) antagonists - vydura is indicated for theacute treatment of migraine with or without aura in adults;preventative treatment of episodic migraine in adults who have at least 4 migraine attacks per month.