Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international n.v.   - bosentan (as monohydrate) - scleroderma, systemic; hypertension, pulmonary - Гипотензивные, - liječenje plućne arterijske hipertenzije (pah) za poboljšanje sposobnosti vježbanja i simptoma u bolesnika s who funkcionalnom klasom iii. efficacy has been shown in: , primary (idiopathic and familial) pah;, pah secondary to scleroderma without significant interstitial pulmonary disease;, pah associated with congenital systemic-to-pulmonary shunts and eisenmenger's physiology. neka poboljšanja su također je prikazano u bolesnika s lag, koji funkcionalna klasa ii. tracleer također je istakao smanjenje broja novih digitalne ulkusa kod pacijenata sa sistemske склеродермией i tijeku bolesti digitalni ulkus .

Europska Unija - hrvatski - EMA (European Medicines Agency)

sanofi winthrop industrie - inzulin гларгин, lixisenatide - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without sglt-2 inhibitors.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pfizer europe ma eeig - tigecycline - bacterial infections; skin diseases, bacterial; soft tissue infections - antibakterijski lijekovi za sistemsku primjenu, - tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , complicated skin and soft tissue infections (cssti), excluding diabetic foot infections, complicated intra-abdominal infections (ciai) , tygacil should be used only in situations where other alternative antibiotics are not suitable. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika. pravilno korištenje antibakterijskih sredstava.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international nv - Этравирин - hiv infekcije - non-nucleoside reverse transcriptase inhibitors, antivirals for systemic use - intelence, u kombinaciji s jačanju proteaze i druge antiretrovirusne lijekove, je indiciran za liječenje ljudskih-imunodeficijencije-virus-tip-1 (hiv-1) infekcije u odraslih bolesnika s antiretrovirusne liječeni i antiretrovirusne liječeni pedijatrijskih bolesnika od šest godina. ovaj prikaz se temelji na tjedan-48 analize dvije faze iii kliničkih ispitivanja vrhunski obučena pacijenata, gdje Интеленс proučavan je u kombinaciji s optimiziranim sheme (arr), koja je uključivala дарунавир/ritonavir. napomena u pedijatrijskoj oboljelih se temelji na 48-tjedan analiza jednom rukom, u drugoj fazi suđenja u arv-liječenje-iskusan pedijatrijska bolesnika.

Europska Unija - hrvatski - EMA (European Medicines Agency)

janssen-cilag international n.v.    - rilpivirin hidroklorid - hiv infekcije - antivirusni lijekovi za sustavnu uporabu - edurant, u kombinaciji s drugim antiretrovirusne lijekove, je indiciran za liječenje humane imunodeficijencije tip 1 (hiv‑1) infekcija u bolesnika treatment‑naïve antiretrovirusne 12 godina i stariji sa viremija ≤ 100 000 hiv‑1 rna kopija/ml. kao i s drugim антиретровирусными lijekovima генотипическое ispitivanje otpora treba biti vođena pri korištenju edurant.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bayer ag - darolutamide - tumori prostate, Кастраци-uporan - endokrinska terapija - nubeqa is indicated for the treatment of adult men with- non metastatic castration resistant prostate cancer (nmcrpc) who are at high risk of developing metastatic disease (see section 5. - metastatic hormone sensitive prostate cancer (mhspc) in combination with docetaxel and androgen deprivation therapy (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

ipsen pharma - cabozantinib - neoplazme štitnjače - antineoplastična sredstva - liječenje odraslih bolesnika s progresivnim, neosjetljivim lokalno naprednim ili metastaznim karcinomom medularnog štitnjače.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - olaparib - neoplazme jajnika - antineoplastična sredstva - jajnika cancerlynparza prikazan kao monoterapija za:podržava liječenje odraslih bolesnika s поздними (figo faze iii i iv) u genima brca1/2-mutirani (зародышевой linije i/ili somatskih) brzorezni epitela jajnika, masterbatch cijevi ili primarni перитонеальный rak, koji u odgovor (potpuno ili djelomično) nakon završetka prve linije na bazi platine kemoterapije. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 i 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacijenti moraju prethodno bile tretirane s антрациклина i таксана u (neo)adjuvantne ili метастатический, ako pacijenti nisu prikladni za tih postupaka (vidi odjeljak 5. pacijenti s receptore hormona (h)-pozitivnog raka dojke treba također razvili ili nakon pre-hormonska terapija, ili se smatraju neprikladnim za endokrine terapije. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

astrazeneca ab - acalabrutinib - leukemija, limfocitna, kronična, b-stanica - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll). calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

takeda gmbh - dengue virus, serotype 2, expressing dengue virus, serotype 1, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 3, surface proteins, live, attenuated, dengue virus, serotype 2, expressing dengue virus, serotype 4, surface proteins, live, attenuated, dengue virus, serotype 2, live, attenuated - denga - cjepiva - qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age. the use of qdenga should be in accordance with official recommendations.