Iclusig Europska Unija - hrvatski - EMA (European Medicines Agency)

iclusig

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. pogledajte odjeljke 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Pemazyre Europska Unija - hrvatski - EMA (European Medicines Agency)

pemazyre

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - antineoplastična sredstva - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Minjuvi Europska Unija - hrvatski - EMA (European Medicines Agency)

minjuvi

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - antineoplastična sredstva - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

Opzelura Europska Unija - hrvatski - EMA (European Medicines Agency)

opzelura

incyte biosciences distribution b.v. - ruxolitinib phosphate - vitiligo - ostali dermatološki pripravci - opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Improvac Europska Unija - hrvatski - EMA (European Medicines Agency)

improvac

zoetis belgium sa - synthetic peptide analogue of gnrf conjugated to diptheria toxoid - imunološke za suidae - male pigs (from 8 weeks of age); female pigs (from 14 weeks of age) - male pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of testicular function. for use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty. drugi ključni čimbenik za svinjsku kosu, skatole, također može biti smanjen kao neizravni učinak. također su smanjene agresivne i seksualne (montirane) ponašanja. female pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of ovarian function (suppression of oestrus) in order to reduce the incidence of unwanted pregnancies in gilts intended for slaughter, and to reduce the associated sexual behaviour (standing oestrus).

Vegzelma Europska Unija - hrvatski - EMA (European Medicines Agency)

vegzelma

celltrion healthcare hungary kft. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. vegzelma in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with vegzelma in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. vegzelma, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. vegzelma, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

CORIS BIOCONCEPT IN VITRO DIJAGNOSTIČKI MEDICINSKI PROIZVODI Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

coris bioconcept in vitro dijagnostiČki medicinski proizvodi

incite kod d.o.o., zagreb - in vitro dijagnostika, određivanje određenih virusa i bakterija

Conbriza Europska Unija - hrvatski - EMA (European Medicines Agency)

conbriza

pfizer europe ma eeig - bazedoxifene - osteoporoza, postmenopauzalna - spolni hormoni i modulatori genitalnog sustava, - conbriza je indiciran za liječenje osteoporoze u postmenopauzi kod žena s povećanim rizikom od prijeloma. značajno smanjenje incidencije fraktura kralješaka je dokazano; djelotvornost na prijelome kuka nije utvrđena. pri određivanju izbor conbriza ili druge vrste terapije, uključujući i estrogena za određenu žene u postmenopauzi, treba uzeti u obzir simptome menopauze, utjecaj na maternice i tkiva dojke i kardiovaskularne rizike i koristi.