Vantavo (previously Alendronate sodium and colecalciferol, MSD) Europska Unija - hrvatski - EMA (European Medicines Agency)

vantavo (previously alendronate sodium and colecalciferol, msd)

n.v. organon - alendronic kiseline, colecalciferol - osteoporoza, postmenopauzalna - lijekovi za liječenje bolesti kostiju - liječenje osteoporoze u postmenopauzi u bolesnika s rizikom od insuficijencije vitamina d. vantavo smanjuje rizik od prijeloma kralježnice i kukova . liječenje постменопаузального osteoporoze kod bolesnika koji ne primaju vitamina d prehrani i rizika vitamina d bubrega. vantavo smanjuje rizik od prijeloma kralježnice i kukova .

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

wegovy

novo nordisk a/s - semaglutide - obesity; overweight - pripravci protiv pretilosti, isključujući. prehrambeni proizvodi - wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial body mass index (bmi) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to.

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

ebvallo

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

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

vaxelis

mcm vaccine b.v. - Дифтерийный анатоксин, столбнячный анатоксин, Бордетеллы pertusisa antigeni: коклюшный анатоксин, vlaknast гемагглютинина, пертактин, фимбрии vrste 2 i 3, površinski antigen virusa hepatitisa b se proizvodi u stanicama kvasca, dječje paralize (инактивированная): tip 1 (mahoney), tip 2 (ω-1), tip 3 (saukett), proizvedenih u kulturi перевиваемых stanica vero/ гемофильная infekcija tipa b polisaharida (polyribosylribitol fosfat), конъюгированное s менингококковым proteinima. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - cjepiva - vaxelis (dtap-hb-ipv-hib) je indiciran za primarne i booster cijepljenja u dojenčadi i male djece u dobi od 6 tjedana, protiv difterije, tetanusa, protiv pertusisa, hepatitisa b, poliomijelitisa i invazivnih bolesti uzrokovane haemophilus influenzae tip b (hib). korištenje vaxelisa treba biti u skladu s službenim preporukama.

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

steglatro

merck sharp & dohme b.v. - ertugliflozin l-pyroglutamic kiselina - dijabetes mellitus, tip 2 - drugs used in diabetes, sodium-glucose co-transporter 2 (sglt2) inhibitors - steglatro prikazan u odraslih osoba u dobi od 18 godina i stariji sa dijabetesom tipa 2 kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole:kao monoterapija kod bolesnika za koje primjena метформина se smatra da je neprimjereno zbog netolerancije ili kontraindikacija. osim drugih lijekova za liječenje šećerne bolesti.

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

aybintio

samsung bioepis nl b.v. - 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 - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio 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. 1 of the smpc. aybintio 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 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. 1 of the smpc. aybintio, 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 other than predominantly squamous cell histology. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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. 1 of the smpc). aybintio, 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 vegf inhibitors or vegf receptor targeted agents. aybintio, in combination with 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. 1 of the smpc). aybintio, 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. 1 of the smpc).

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

onbevzi

samsung bioepis nl b.v. - 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 - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi 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. onbevzi 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 onbevzi in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. onbevzi, 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 other than predominantly squamous cell histology. onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, 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. onbevzi, 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 vegf inhibitors or vegf receptor targeted agents. onbevzi, in combination with 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. onbevzi, 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.

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

firmagon

ferring pharmaceuticals a/s - degarelix - prostatske neoplazme - endokrinska terapija - firmagon is a gonadotrophin releasing hormone (gnrh) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

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

invokana

janssen-cilag international nv - canagliflozin - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 i 5.

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

ontruzant

samsung bioepis nl b.v. - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastična sredstva - grudi cancermetastatic grudi cancerontruzant indiciran za liječenje odraslih bolesnika s her2 pozitivnim metastatskih tumora dojke (mbk):u monoterapiji za liječenje onih pacijenata koji su primili najmanje dva načina kemoterapije za метастатической bolesti. prije kemoterapije moraju biti uključena barem антрациклина i таксана, ako pacijenti nisu prikladni za tih postupaka. hormon-receptor-pozitivnih bolesnika također mora biti hormonske terapije, ako pacijenti nisu prikladni za tih postupaka. u kombinaciji s паклитакселом za liječenje onih pacijenata koji nisu primili kemoterapiju za метастатической bolesti i za koga антрациклиновый ne odgovara. u kombinaciju sa docetaxel za liječenje bolesnika koji nisu primali kemoterapiju za метастатической bolesti. u kombinaciji s inhibitor aromataze za liječenje pacijenata u postmenopauzi s hormon-receptor pozitivnim ГБЦ, ne ranije liječenih трастузумаб. rano cancerontruzant grudi indiciran za liječenje odraslih bolesnika s her2 pozitivnim karcinomom dojke (ЕДК)nakon operacije, kemoterapije (неоадъювантной ili adjuvantne) i radioterapije (ako je primjenjivo). nakon adjuvantne kemoterapije doksorubicin i ciklofosfamid, u kombinaciji s паклитакселом ili docetaxel. u kombinaciji s adjuvantne kemoterapije, koji se sastoji od доцетаксела i карбоплатина. u kombinaciji s неоадъювантной kemoterapije, nakon čega slijedi ontruzant adjuvantne terapije, lokalno (uključujući i upalne bolesti ili tumora >2 cm u promjeru. ontruzant treba koristiti samo u bolesnika s metastaze ili ranog raka dojke, tumora kojih je bilo her2 i гиперэкспрессии ili амплификации gena her2, kako se određuje točan i dokazani анализами. Метастатические cancerontruzant želuca u kombinaciji s Капецитабин ili 5‑фторурацилом i цисплатином indiciran za liječenje odraslih bolesnika s her2 pozitivnim metastaze аденокарциномой želučane ili probavne пищеводный veze, koji nisu primili do противоопухолевое liječenje bolesti метастатической. ontruzant treba koristiti samo u bolesnika s диссеминированным raka želuca (lecs), čiji je tumor гиперэкспрессии her2 i kako se određuje ihc2+ i prateću СИШ ili ribe rezultat, ili igh 3+ rezultat. treba koristiti točne i dokazane metode analize .