Europska Unija - hrvatski - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - cangrelor - acute coronary syndrome; vascular surgical procedures - antitrombotska sredstva - kengrexal, primijenjen istodobno s acetilsalicilnom kiselinom (asa), je indiciran za smanjenje trombotski kardiovaskularnih događaja u odraslih bolesnika s bolesti koronarnih arterija prolazi kroz perkutana koronarna intervencija (pci) koji su primali oralne p2y12 inhibitora prije pci postupak i u kojem oralne terapije inhibitorima p2y12 nije moguće ili poželjno.

Europska Unija - hrvatski - EMA (European Medicines Agency)

pfizer europe ma eeig - Тофацитиниб - artritis, reumatoidni - imunosupresivi - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 i 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - прасугрель besilate - myocardial infarction; acute coronary syndrome; angina, unstable - antitrombotska sredstva - Прасугрель Майлана, propisana u suradnji s ацетилсалициловой kiselina (ask), prikazana je za prevenciju атеротромботических događaja kod odraslih pacijenata s akutnim коронарным sindromom (ja. nestabilna angina, non-porast segmenta st infarkt miokarda [val/ami bez elevacije st segmenta] ili porast segmenta st infarkt miokarda [ami s элевацией st]), patili primarni ili kasniti чрескожное koronarne intervencije (ЧКВ).

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan pharmaceuticals limited - acetylsalicylic acid, clopidogrel hydrogen sulfate - acute coronary syndrome; myocardial infarction - antitrombotska sredstva - Клопидогрел/Ацетилсалициловая kiselina mylan u indiciran za sekundarnu prevenciju атеротромботических događaja kod odraslih pacijenata već prihvatiti kao клопидогрела i ацетилсалициловой kiseline (ask). Клопидогрел/Ацетилсалициловая kiselina mylan u fiksne doze kombiniranog medicinskih proizvoda za nastavak liječenja:ne porast segmenta st akutna koronarna sindrom (nestabilna angina, ili ne-q-infarkt miokarda), uključujući i bolesnike koji su patili стентирование nakon чрескожных koronarnih interventionst porast u segmentu akutnog infarkta miokarda u liječenju pacijenata koji imaju pravo na thrombolytic terapije.

Europska Unija - hrvatski - EMA (European Medicines Agency)

aop orphan pharmaceuticals gmbh - ropeginterferon alfa-2b - istinska Полицитемия - Иммуностимуляторы, - besremi prikazan kao monoterapija kod odraslih za liječenje полицитемия vjera bez simptomatske спленомегалии.

Bosna i Hercegovina - hrvatski - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

roche d.o.o.roche ltd. - peginterferon alfa2a - rastvor za injekciju u napunjenom špricu - 180 µg/0.5 ml - 0,5 ml rastvora za injekciju u napunjenoj šprici sadrži: 180 mcg peginterferon alfa2a

Europska Unija - hrvatski - EMA (European Medicines Agency)

mylan s.a.s - ribavirin - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - ribavirin mylan je indiciran za liječenje kroničnog hepatitisa c i mora se koristiti samo kao dio kombiniranom s interferonom alfa-2b (odrasli, djeca (u dobi od tri ili više godina) i adolescente). ribavirin monoterapija se ne smije koristiti. ne postoji sigurnost ili učinkovitost primjene informacijskih рибавирина s drugim oblicima interferona (ja. ne alfa-2b). molimo, molimo, takođe pročitajte i s interferonom alfa-2b kratak opis robe (Смпц) za прописывания informacije određene proizvode. naivno patientsadult patientsribavirin mylan navedene u kombinaciji s interferonom alfa-2b, za liječenje odraslih bolesnika sa svim vrstama kroničnog hepatitisa c, osim genotip 1, prethodno obrađene, bez декомпенсации jetre, povećane razine аланинаминотрансферазы (alt), koji su pozitivni za serumu hepatitisa b-s-virus (hcv) rna. djeca i adolescentsribavirin mylan u drugačije, na način kombinaciji s interferonom alfa-2b, za liječenje djece i adolescenata u dobi od tri godine i stariji, koji imaju sve vrste kroničnog hepatitisa c, osim genotip 1, prethodno obrađene, bez jetre декомпенсация, i koje su pozitivne u serumu rnk hcv. odlučujući neće odgoditi liječenje do odrasle dobi, važno je uzeti u obzir da je kombinirana terapija uzrokuje zadržavanje rasta . Обратимость inhibicije rasta povjerenja. odluka mora biti donesena na individualnoj osnovi (vidi odjeljak 4. prethodno liječenje-odricanje patientsadult patientsribavirin mylan navedene u kombinaciji s interferonom alfa-2b, za liječenje odraslih bolesnika s kroničnim hepatitisom c koji su prethodno odgovorili (sa normalizaciji alt na kraju tretmana) s interferonom alfa kao monoterapija, ali se naknadno ponavljanje.

Europska Unija - hrvatski - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - antineoplastična sredstva - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

teva b.v. - ribavirin - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) in adults (see sections 4. 2, 4. 4 i 5. ribavirin teva pharma b. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis c (chc) for paediatric patients (children 3 years of age and older and adolescents) notpreviously treated and without liver decompensation (see sections 4. 2, 4. 4 i 5.

Europska Unija - hrvatski - EMA (European Medicines Agency)

teva b.v. - ribavirin - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - ribavirin teva je indiciran za liječenje kroničnog hepatitisa c virus (hcv) infekcija u odraslih, djeca od 3 godine starosti i starije i adolescenata i mora se koristiti samo kao dio kombiniranom s interferonom alfa-2b. ribavirin monoterapija se ne smije koristiti. ne postoji sigurnost ili učinkovitost primjene informacijskih рибавирина s drugim oblicima interferona (ja. ne alfa-2b). naivnih pacijenata odrasli pacijenti ribavirin tewa drugačije, u kombinaciji s interferonom alfa-2b, za liječenje odraslih bolesnika sa svim vrstama kroničnog hepatitisa c, osim genotip 1, prethodno obrađene, bez декомпенсации jetre, povećane razine аланинаминотрансферазы (alt), koji su pozitivni za hepatitis c virusne ribonucleic kiseline rnk hcv. Педиатрические pacijenti (djeca od 3 godine i starije i mlade) ribavirin tewa drugačije, kombinacije lijekova s interferonom alfa2b, za liječenje djece i adolescenata u dobi od 3 godina i stariji, koji imaju sve vrste kroničnog hepatitisa c, osim genotip 1, prethodno obrađene, bez jetre u fazi декомпенсации, a koji je pozitivan za hcv-rna. donošenju odluke da se neće odgoditi liječenje do odrasle dobi, važno je uzeti u obzir da je kombinirana terapija uzrokuje zadržavanje rasta, koji može biti nepovratan u nekih bolesnika. Обратимость inhibicije rasta povjerenja. odluka mora biti donesena na individualnoj osnovi. prethodnih neuspjeha liječenja patientsadult pacijenata ribavirin tewa drugačije, u kombinaciji s interferonom alfa-2b, za liječenje odraslih bolesnika s kroničnim hepatitisom c koji su prethodno odgovorili (sa normalizaciji alt na kraju tretmana) kao monoterapija interferonom alfa, ali se naknadno ponavljanje.