GARDASIL 20 µg/0.5 mL+ 40 µg/0.5 mL+ 40 µg/0.5 mL+ 20 µg/0.5 mL suspenzija za injekciju u  napunjenoj šprici บอสเนียและเฮอร์เซโกวีนา - โครเอเชีย - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

gardasil 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml suspenzija za injekciju u napunjenoj šprici

merck sharp & dohme bh d.o.o. - papilomavirus (humanitarne tipovi 6, 11, 16, 18) - suspenzija za injekciju u napunjenoj šprici - 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml - 0,5 ml (1 doza) suspenzije za injekciju u napunjenoj šprici sadrži: 20 mcg humani papilomavirus tip 6 l1 protein 40 mcg humani papilomavirus tip 11 l1 protein 40 mcg humani papilomavirus tip 16 l1 protein 20 mcg humani papilomavirus tip 18 l1 protein

GARDASIL 20 µg/0.5 mL+ 40 µg/0.5 mL+ 40 µg/0.5 mL+ 20 µg/0.5 mL suspenzija za injekciju u  napunjenoj šprici บอสเนียและเฮอร์เซโกวีนา - โครเอเชีย - Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (Агенција за лијекове и медицинска средства Босне и Херцеговине)

gardasil 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml suspenzija za injekciju u napunjenoj šprici

merck sharp & dohme bh d.o.o. - papilomavirus (humanitarne tipovi 6, 11, 16, 18) - suspenzija za injekciju u napunjenoj šprici - 20 µg/0.5 ml+ 40 µg/0.5 ml+ 40 µg/0.5 ml+ 20 µg/0.5 ml - 0,5 ml (1 doza) suspenzije za injekciju u napunjenoj šprici sadrži: 20 mcg humani papilomavirus tip 6 l1 protein 40 mcg humani papilomavirus tip 11 l1 protein 40 mcg humani papilomavirus tip 16 l1protein 20 mcg humani papilomavirus tip 18 l1 protein

HBVaxPro สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

hbvaxpro

merck sharp & dohme b.v.  - hepatitis b, rekombinantni površinski antigen - hepatitis b; immunization - cjepiva - 5 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-b virus. određene grupe rizika će biti cijepljeni moraju biti definirani na temelju službenih preporuka. može se očekivati da hepatitis d se također može spriječiti putem cijepljenja s hbvaxpro kao što su hepatitis d (uzrokovana agent delta) ne nalazi u nedostatku virusa hepatitis b infekcije. 10 micrograms hbvaxpro is indicated for active immunisation against hepatitis-b-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-b virus. određene grupe rizika će biti cijepljeni moraju biti definirani na temelju službenih preporuka. može se očekivati da hepatitis d se također može spriječiti putem cijepljenja s hbvaxpro kao što su hepatitis d (uzrokovana agent delta) ne nalazi u nedostatku virusa hepatitis b infekcije. 40 micrograms hbvaxpro is indicated for the active immunisation against hepatitis-b-virus infection caused by all known subtypes in predialysis and dialysis adult patients. može se očekivati da hepatitis d također će spriječiti stvaranje imunizacije s hbvaxpro kao što su hepatitis d (uzrokovana agent delta) ne nalazi u nedostatku virusa hepatitisa b .

Fertavid สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

fertavid

merck sharp & dohme b.v.  - follitropin beta - infertility; hypogonadism - spolni hormoni i modulatori genitalnog sustava, - u ženskom:fertavid indiciran za liječenje ženske neplodnosti u sljedećim kliničkim slučajevima:ановуляция (uključujući policističnih jajnika bolest, koncept пбвп), kod žena koje su ne поддающаяся liječenju s clomifene citratecontrolled hiperstimulacije jajnika za indukciju razvoj više folikula u lijekovima kopiranje programa [e-mail. in vitro oplodnje/presađivanje embrija (ivf/pe), гаметы unutar-маточную prijenosa (poklon) i интрацитоплазматическая injekcije spermija (icsi). muški:nedovoljan spermatogeneze zbog hypogonadotrophic гипогонадизм.

Keytruda สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

keytruda

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.

Esmeron 10 mg/ml otopina za injekciju/infuziju โครเอเชีย - โครเอเชีย - HALMED (Agencija za lijekove i medicinske proizvode)

esmeron 10 mg/ml otopina za injekciju/infuziju

merck sharp & dohme d.o.o., ivana lučića 2a, zagreb, hrvatska - rokuronijev bromid - otopina za injekciju/infuziju - 10 mg/ml - urbroj: 1 ml otopine sadrži 10 mg rokuronijevog bromida

Recarbrio สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

recarbrio

merck sharp & dohme b.v.  - monohidrat Имипенем, циластатин natrija, relebactam monohidrat - Грамотрицательные bakterijske infekcije - carbapenems, antibacterials for systemic use, - recarbrio is indicated for:- treatment of hospital-acquired pneumonia (hap), including ventilator associated pneumonia (vap), in adults (see sections 4. 4 i 5. - treatment of bacteraemia that occurs in association with, or is suspected to be associated with hap or vap, in adults. - treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options (see sections 4. 2, 4. 4 i 5. treba uzeti u obzir formalne preporuke za odgovarajuće korištenje antibakterijskih posrednika.

Gardasil 9 สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

gardasil 9

merck sharp & dohme b.v. - cjepivo protiv humanog papiloma virusa [tipovi 6, 11, 16, 18, 31, 33, 45, 52, 58] (rekombinantni, adsorbirani) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - cjepivo protiv папилломавируса - Гардасил 9 prikazana je za aktivne imunizacije ljudi u dobi od 9 godina protiv hpv-a sljedeće bolesti:prekanceroznih lezija i raka, koji utječu na vrat maternice, rukom stimulirati vulvu, vaginu i anus, zbog cjepiva protiv hpv-a typesgenital bradavice (acuminata acuminata) uzrokovanih hpv određene vrste. pogledajte odjeljke 4. 4 i 5. 1 za dobivanje važnih informacija o podacima koji podržavaju ove indikacije. korištenje Гардасила 9 moraju biti u skladu sa službenim preporukama.

ProQuad สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

proquad

merck sharp & dohme b.v. - virus, uživo umanji, ospice, virus, živjeti atenuiranih, zaušnjaka, virus, živjeti atenuiranih, rubeola, virus, uživo umanji, varičela - chickenpox; rubella; measles; mumps; immunization - cjepiva - proquad je indiciran za istodobno cijepljenje protiv ospica, zaušnjaka, rubeole i varicele kod osoba od 12 mjeseci starosti. proquad može se dodijeliti osobama s 9 mjeseci starosti u slučaju posebnih okolnosti (e. u skladu s nacionalnim kalendarom cijepljenja, situacijama flash, ili putovanje u regija s visokim заболеваемостью корью.

Cancidas (previously Caspofungin MSD) สหภาพยุโรป - โครเอเชีย - EMA (European Medicines Agency)

cancidas (previously caspofungin msd)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimikotika za sustavnu uporabu - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.