Česká republika - čeština - USKVBL (Ústav Pro Státní Kontrolu Veterinárních Biopreparátů A Léčiv)

industria italiana integratori trei, s.p.a. - doxycyklin - prášek pro perorální roztok - tetracykliny - prasata, brojleři kura domácího, krůty

Evropská unie - čeština - EMA (European Medicines Agency)

astrazeneca ab - glycopyrronium, formoterol fumarate dihydrate - plicní onemocnění, chronická obstrukční - formoterol a glykopyrronium-bromid - bevespi aerosphere je indikován jako udržovací bronchodilatační léčba k úlevě od příznaků u dospělých pacientů s chronickou obstrukční plicní nemocí (chopn).

Evropská unie - čeština - EMA (European Medicines Agency)

sandoz gmbh - pegfilgrastim - neutropenie - imunostimulancia, - zkrácení doby trvání neutropenie a incidence febrilní neutropenie u dospělých pacientů léčených cytotoxickou chemoterapií pro malignitu (s výjimkou chronické myeloidní leukémie a myelodysplastických syndromů).

Evropská unie - čeština - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - další ophthalmologicals - luxturna je indikován k léčbě dospělých a pediatrických pacientů se ztrátou zraku v důsledku dědičné oční sítnice dystrofie způsobené potvrdil biallelic rpe65 mutace a kteří mají dostatek životaschopných buněk sítnice.

Evropská unie - čeština - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombotické činidla - prevence žilní tromboembolie (vte) u dospělých pacientů, kteří podstoupili elektivní operaci náhrady kyčelního nebo kolenního kloubu. léčba hluboké žilní trombózy (dvt) a plicní embolie (pe) a prevence rekurentní dvt a pe u dospělých. (see section 4. 4 for haemodynamically unstable pe patients. léčba hluboké žilní trombózy (dvt) a plicní embolie (pe) a prevence rekurentní dvt a pe u dospělých. (see section 4. 4 pro hemodynamicky nestabilní pe pacientů). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. léčba hluboké žilní trombózy (dvt) a plicní embolie (pe) a prevence rekurentní dvt a pe u dospělých. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 a 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. léčba hluboké žilní trombózy (dvt) a plicní embolie (pe) a prevence rekurentní dvt a pe u dospělých. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Česká republika - čeština - USKVBL (Ústav Pro Státní Kontrolu Veterinárních Biopreparátů A Léčiv)

livisto int'l, s.l. - doxycyklin - prášek pro podání v pitné vodě - tetracykliny - prasata, kur domácí, krůty

Evropská unie - čeština - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - roztroušená skleróza, relaps-remitentní - 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.

Evropská unie - čeština - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotické činidla - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Evropská unie - čeština - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastická činidla - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Česká republika - čeština - Adama

adama - suspenzní koncentrát - fluazinam - fungicidy