Europese Unie - Estlands - EMA (European Medicines Agency)

pfizer europe ma eeig  - rituksimab - leukemia, lymphocytic, chronic, b-cell; arthritis, rheumatoid; microscopic polyangiitis; pemphigus - antineoplastilised ained - ruxience on näidatud täiskasvanute jaoks järgmisi andmeid:mitte‑hodgkini lümfoom (nhl)ruxience on näidustatud raviks eelnevalt ravimata patsientidel etapp iii‑iv follikulaarne lümfoom kombinatsioonis keemiaraviga. ruxience säilitusravi, on näidustatud ravi follikulaarne lümfoom patsientide reageerimine induktsiooni teraapia. ruxience monotherapy on näidustatud patsientidele, kellel etapp iii‑iv follikulaarne lümfoom, kes on chemoresistant või on oma teine või järgmine hakkavad pärast keemiaravi. ruxience on näidustatud patsientide raviks cd20 positiivne hajus suur b-rakkude mitte‑hodgkini lümfoom koos karbonaad (tsüklofosfamiid, doxorubicin, vincristine, prednisoloon) keemiaravi. krooniline lümfoidne leukeemia (cll)ruxience kombinatsioonis keemiaraviga on näidustatud patsientide raviks eelnevalt ravimata ja taastekkinud/tulekindlad cll. ainult piiratud andmed on saadaval efektiivsust ja ohutust patsientidel, eelnevalt ravitud monoklonaalsete antikehadega (sealhulgas rituksimabi või patsientidel, tulekindlad, et eelmise rituksimabi pluss kemoteraapiat. reumatoidartriidi arthritisruxience koos metotreksaadi on näidustatud ravi täiskasvanud patsientidel, kellel on raske aktiivne reumatoidartriit, kes on ebaadekvaatne reaktsioon või talu teisi haigust moduleeriva anti‑reumaatilised ravimeid (dmard), sh ühte või enamat tuumori nekroosi faktori (tnf) inhibiitorite ravi. ruxience on näidanud, et vähendada määra progressioon ühise kahju, mida mõõdetakse x‑ray ja parandab füüsilist funktsiooni, kui antud koos metotreksaadi. granulomatosis koos polyangiitis ja mikroskoopilised polyangiitisruxience, koos glucocorticoids, on näidustatud ravi täiskasvanud patsientidel, kellel on raske, aktiivse granulomatosis koos polyangiitis (wegener ' s) (gpa) ja mikroskoopilised polyangiitis (mpa). pemphigus vulgarisruxience on näidustatud ravi patsientidel, kellel on mõõdukas kuni raske pemphigus vulgaris (pv).

Europese Unie - Estlands - EMA (European Medicines Agency)

accord healthcare s.l.u. - fingolimod vesinikkloriid - sclerosis multiplex, relapsing-remitting - immunosuppressants, valikuline immunosuppressants - märgitud ühe haigust moduleeriva ravi väga aktiivne relapsing remitting sclerosis multiplex järgmiste rühmade täiskasvanud patsientidel ja lastel patsientidel vanuses 10 aastat ja vanemad:patsiendid, kellel on väga aktiivne haiguse vaatamata täielikku ja piisavat ravi vältel vähemalt ühe haigust moduleeriva therapyorpatients kiiresti arenev raske relapsing remitting sclerosis multiplex määratud 2 või enam puuet ägenemiste ühe aasta, ja on 1 või enam gadoliinium suurendada kahjustused aju mri või olulist kasvu, t2 kahjustus koormus võrreldes varasema hiljutise mrt.

Europese Unie - Estlands - EMA (European Medicines Agency)

vetoquinol - tulatromütsiin - antibakteriaalsed ained süsteemseks kasutamiseks - cattle; pigs; sheep - cattle: treatment and metaphylaxis of bovine respiratory disease (brd) associated with mannheimia haemolytica, pasteurella multocida, histophilus somni and mycoplasma bovis susceptible to tulathromycin. haiguse esinemine karjas tuleb kindlaks määrata enne metafülaktilist ravi. treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis susceptible to tulathromycin. pigs: treatment and metaphylaxis of swine respiratory disease (srd) associated with actinobacillus pleuropneumoniae, pasteurella multocida, mycoplasma hyopneumoniae, haemophilus parasuis and bordetella bronchiseptica susceptible to tulathromycin. haiguse esinemine karjas tuleb kindlaks määrata enne metafülaktilist ravi. the product should only be used if pigs are expected to develop the disease within 2–3 days. lambad: nakkusliku pododermatiidi (suu mädanemine) varajase staadiumi ravi, mis on seotud virulentse dichelobacter nodosus'ega ja vajab süsteemset ravi.

Europese Unie - Estlands - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroksabaan - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombootilised ained - täiskasvanud patsientidel, kellele tehti plaaniline puusa- või põlveliigese asendamise operatsiooni venoosse trombemboolia (vte) ennetamine. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. (see section 4. 4 for haemodynamically unstable pe patients. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. (see section 4. 4 haemodynamically ebastabiilne pe patsientidel). 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. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. (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 ja 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. ravi süvaveenide tromboos (dvt) ja kopsuarteri emboolia (pe), ning ennetamine korduvate digi-tv ja pe täiskasvanutel. (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.

Europese Unie - Estlands - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - lihase atroofia, spinaalne - muud lihas-skeleti süsteemi häirete ravimid - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

Europese Unie - Estlands - EMA (European Medicines Agency)

pinax pharma gmbh - ioflupane (123i) - radionuclide imaging; dementia; movement disorders - diagnostilised radiofarmatseutilised ühendid - see ravim on mõeldud ainult diagnostiliseks kasutamiseks. celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:in adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic parkinson’s disease, multiple system atrophy and progressive supranuclear palsy.  celsunax is unable to discriminate between parkinson's disease, multiple system atrophy and progressive supranuclear palsy. täiskasvanud patsientidel, et aidata eristada arvatav dementsus koos lewy kehad alzheimeri tõbi.  celsunax is unable to discriminate between dementia with lewy bodies and parkinson’s disease dementia.

Europese Unie - Estlands - EMA (European Medicines Agency)

mylan ireland limited - fingolimod vesinikkloriid - sclerosis multiplex, relapsing-remitting - immunosupressandid - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 ja 5. 1)orpatients kiiresti arenev raske relapsing remitting sclerosis multiplex määratud 2 või enam puuet ägenemiste ühe aasta, ja on 1 või enam gadoliinium suurendada kahjustused aju mri või olulist kasvu, t2 kahjustus koormus võrreldes varasema hiljutise mrt.

Europese Unie - Estlands - EMA (European Medicines Agency)

mylan ireland limited - rivaroksabaan - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombootilised ained - 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.

Europese Unie - Estlands - EMA (European Medicines Agency)

mylan ireland limited - fingolimod vesinikkloriid - sclerosis multiplex, relapsing-remitting - immunosupressandid - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 ja 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Europese Unie - Estlands - EMA (European Medicines Agency)

vetcare oy - medetomidine hydrochloride, vatinoxan hydrochloride - psühhoeptikumid, uinutid ja rahustid - koerad - to provide restraint, sedation and analgesia during conduct of non-invasive, non-painful or mildly painful procedures and examinations intended to last no more than 30 minutes.