União Europeia - croata - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - tip papilloma virus 6 Л1 sirutke papilloma virus tipa 11 Л1 sirutke papilloma virus tipa 16 Л1 sirutke papilloma virus tipa 18 Л1 proteina - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - cjepiva - cjepivo Гардасил prikazana je u primjeni u dobi od 9 godina za prevenciju:prekanceroznih lezija genitalnih organa (vrata maternice, vulve i vagine), prekanceroznih lezija analnom području, raka grlića materice i analnog raka, uzročno povezane s određenim онкогенным virusom hpv čovjeka (hpv); genitalne bradavice (acuminata acuminata), uzročno povezane s određenim hpv-a. pogledajte odjeljke 4. 4 i 5. 1 za važne informacije o podacima koji podržavaju ovu oznaku. primjena Гардасил treba u skladu sa službenim preporukama.

União Europeia - croata - EMA (European Medicines Agency)

csl behring gmbh - ljudski normalni imunoglobulin (scig) - sindromi imunološke manjkavosti - imuni serumi i homologna, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

União Europeia - croata - EMA (European Medicines Agency)

intervet international bv - indoxacarb, permethrin - permetrin, kombinacije, ectoparasiticides za vanjsku primjenu, uključujući. insekticidi - psi - liječenje infekcija buha (ctenocephalides felis); proizvod ima trajnu insekticidnu djelotvornost do 4 tjedna protiv ctenocephalides felis. proizvod ima trajnu akaricidnu učinkovitost do 5 tjedana protiv ixodes ricinus i do 3 tjedna protiv rhipicephalus sanguineus. jedan tretman pruža djelovanje protiv odbijanja (anti-feeding) protiv pijeska muha (phlebotomus perniciosus) do 3 tjedna.

União Europeia - croata - EMA (European Medicines Agency)

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent 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. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

União Europeia - croata - EMA (European Medicines Agency)

vétoquinol sa - cimikoksib - mišićno-koštani sustav - psi - reljef boli i upale povezane s osteoartritisom. upravljanje perioperativnim bolovima zbog ortopedskih ili mekih tkiva.

União Europeia - croata - EMA (European Medicines Agency)

avimedical b.v. - itrakonazol - Антимикотиков za sistemsku primjenu, derivat триазола, itrakonazol - ptičja - za liječenje аспергиллеза i kandidijaze kod kućnih ptica,.

União Europeia - croata - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - afoxolaner - Изоксазолинов, ectoparasiticides za sistemsku primjenu - psi - liječenje buha infestacije kod pasa (ctenocephalides feliz i c. канис) u trajanju od najmanje 5 tjedana. proizvod se može koristiti kao dio strategije liječenja za kontrolu buha alergijskog dermatitisa (fad). liječenje zaraza krpelja kod pasa (dermacentor reticulatus, иксодовых ricinusovog, krpelja ixodes hexagonus, rhipicephalus sanguineus). jedna obrada ubija krpelje u roku od jednog mjeseca. blitve i krpelji moraju se priključiti na domaćina i početi hraniti kako bi bili izloženi aktivnoj tvari. liječenje demodectic šuge (uzrokovane демодекс канис). liječenje саркоптозом (bolesti uzrokovane sarcoptes opcije. velikog psa).

União Europeia - croata - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - afoxolaner, милбемициноксима - endectocides, противопаразитарные sredstva, insekticidi i repelenti милбемициноксима, kombinacije - psi - za liječenje buha i krpelja infestacije pasa istovremeno i prevenciju srčanog crva bolesti (srčane crve, ličinke), angiostrongylosis (smanjenje razine nezrele odrasle osobe (Л5) i odrasle angiostrongylus vasorum), телязиозе (odrasli thelazia callipaeda) i/ili liječenje crijevnih hookworms, štetočina, navedeni. tretman je invazija buha (ctenocephalides feliz i c. канис) kod pasa u roku od 5 tjedana. liječenje zarazu krpelja (dermacentor reticulatus, иксодовых ricinusovog, krpelja ixodes hexagonus, rhipicephalus sanguineus) kod pasa u roku od 4 tjedana. blitve i krpelji moraju se priključiti na domaćina i početi hraniti kako bi bili izloženi aktivnoj tvari. liječenje gljivica kod odraslih gastrointestinalne hookworms od sljedećih vrsta: oblići (Тохосага canis i toxascaris leonina ograničen), hookworms (ancylostoma сатпит, анкилостома анкилостома braziliense i ceylanicum) i власоглава (власоглавы vulpis). liječenje demodectic šuge (uzrokovane демодекс канис). liječenje саркоптозом (bolesti uzrokovane sarcoptes opcije. velikog psa). prevencija srčanog crva bolesti (srčane crve, ličinke) s mjesečnim uprave. prevencija angiostrongylosis (smanjenje razine hiv nezrele odrasle osobe (Л5) i odraslog fazama angiostrongylus vasorum) s mjesečnim uprave. sprečavanje stvaranja телязиозе (odrasli thelazia callipaeda eyeworm infekcije) s mjesečnim uprave.

União Europeia - croata - EMA (European Medicines Agency)

merck sharp & dohme b.v. - Пембролизумаб - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastična sredstva - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. pacijenata sa egfr ili ala pozitivnih tumora mutacije također treba primili таргетную terapiju prije dobivanja Кейтруда. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

União Europeia - croata - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - hiperkolesterolemija - sredstva za modifikaciju lipida - lojuxta je indicirana kao dodatak prehrani low‑fat i drugih lipid‑lowering lijekova s ili bez afereze najniža gustoće lipoproteina (ldl) u odraslih bolesnika s homozigotni obiteljska hiperkolesterolemija (hofh). genetičko potvrdu hofh mora biti ispitan na mogućnosti. drugi oblici primarne гиперлипопротейнемия i sekundarni uzroci гиперхолестеринемии (e. nephrotic sindrom, hipotireoza) moraju biti isključeni.