Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - osimertinib mesilate - karcinom, ne-malih stanica pluća - drugi antitumorski lijekovi, inhibitori протеинкиназы - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Europska Unija - hrvatski - EMA (European Medicines Agency)

teva b.v. - rasagilin - parkinsonova bolest - antiparkinsonski lijekovi - rasagiline ratiopharm je indiciran za liječenje idiopatska parkinsonova bolest (pd) kao monoterapija (bez levodope) ili kao dodatak terapija (s levodopom) u bolesnika s kraja doze fluktuacije.

Europska Unija - hrvatski - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - imunosupresivi - molimo pogledajte odjeljak 4. 1 sažetak značajki proizvoda u dokumentu o informacijama o proizvodu.

Europska Unija - hrvatski - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafil - poremećaj erekcije - urologicals - liječenje erektilne disfunkcije kod odraslih muškaraca. da bi tadalafil bio učinkovit, potrebna je seksualna stimulacija. tadalafil lilly ne navodi za žene. liječenje znakova i simptoma benigne hiperplazije prostate kod odraslih muškaraca.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tadalafil - poremećaj erekcije - urologicals - liječenje erektilne disfunkcije kod odraslih muškaraca. da bi tadalafil bio učinkovit, potrebna je seksualna stimulacija. tadalafil mylan u se ne navodi za žene.

Europska Unija - hrvatski - EMA (European Medicines Agency)

billev pharma aps - lutetium (177lu) chloride - radionuklidno slikanje - terapeutski radiofarmaceutski pripravci - lutetium (177lu) chloride billev is a radiopharmaceutical precursor, and it is not intended for direct use in patients. it is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with lutetium (177lu) chloride.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ucb pharma sa - Цертолизумаб pegol - crohn disease - imunosupresivi - cimzia, in combination with methotrexate (mtx), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (ra) in adult patients when the response to disease-modifying antirheumatic drugs (dmard) including methotrexate, has been inadequate. cimzia može biti dano kao monoterapija u slučaju netolerancije метотрексата ili pri stalnom liječenju s metotreksat je nepraktično. cimzia has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate.

Europska Unija - hrvatski - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - aripiprazola - shizofrenija - psycholeptics - održavanje liječenja shizofrenije u odraslih bolesnika stabilizirano je oralnim aripiprazolom.

Europska Unija - hrvatski - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafil - hipertenzija, plućna - urologicals - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. učinkovitost je pokazana u idiopatskom pah (ipah) i pah povezanoj na vaskularnu bolest kolagena. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.

Europska Unija - hrvatski - EMA (European Medicines Agency)

teva b.v. - xinafoate сальметерол, flutikazon propionat - pulmonary disease, chronic obstructive; asthma - lijekovi za opstruktivne plućne bolesti dišnih putova, - spiromax aerivio indiciran za primjenu kod odraslih u dobi od 18 godina i stariji, samo. asthmaaerivio spiromax indiciran za redovito liječenje bolesnika s teškim oblikom astme, gdje je upotreba kombinacije proizvoda (inhalacijskim kortikosteroidima i trajno djeluju β2-agonista) odgovara:pacijentima nije dovoljno kontrolirani na manju snagu kortikosteroidne kombinirani lijek orpatients već prati na visoke doze inhalacijskim kortikosteroidima i trajno djeluju β2-agonista. kronične opstruktivne plućne bolesti (kopb)spiromax aerivio indiciran za simptomatsko liječenje bolesnika s kopb s ОФВ1.