Keytruda الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

keytruda

merck sharp & dohme b.v. - pembrolizumab - 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 - daganatellenes szerek - 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. betegek egfr vagy lÚgos pozitív tumor mutációk is kapott célzott terápia átvétele előtt keytruda. 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.

Purevax RCPCh الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

purevax rcpch

boehringer ingelheim vetmedica gmbh - attenuated feline rhinotracheitis herpesvirus (fhv f2 strain), inactivated feline calicivirosis antigens (fcv 431 and g1 strains), attenuated chlamydophila felis (905 strain), attenuated feline panleucopenia virus (pli iv) - immunológikumok a felidae, - macskák - active immunisation of cats aged eight weeks and older:• against feline viral rhinotracheitis to reduce clinical signs;• against calicivirus infection to reduce clinical signs;• against chlamydophila felis infection to reduce clinical signs;• against feline panleucopenia to prevent mortality and clinical signs. a immunitást a rhinotracheitis, a kalicavírus, a chlamydophila felis és a panleucopenia komponensek elsődleges immunizálás után egy héttel igazolták. the duration of immunity is one year after the last re-vaccination for the chlamydiosis component, and oneyear after primary vaccination and three years after the last re-vaccination for the rhinotracheitis, calicivirosis and panleucopenia components.

Infanrix Penta الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

infanrix penta

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (mahoney strain), type 2 (mef-1 strain), type 3 (saukett strain)), hepatitis b surface antigen - hepatitis b; tetanus; immunization; whooping cough; poliomyelitis; diphtheria - a vakcinák - az infanrix penta a csecsemők elsődleges és emlékeztető vakcinázására ajánlott a diftéria, tetanusz, pertussis, hepatitisz b és poliomyelitis ellen.

Ribavirin Teva Pharma B.V. الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

ribavirin teva pharma b.v.

teva b.v. - a ribavirin - hepatitis c, krónikus - vírusellenes szerek szisztémás alkalmazásra - 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, 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 és 5.

Verzenios الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

verzenios

eli lilly nederland b.v. - abemaciclib - mellnövekedés - daganatellenes szerek - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5. in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist. advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Bexsero الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

bexsero

gsk vaccines s.r.l. - külső membrán hólyagok a neisseria meningitidis b csoport (törzs nz 98/254), rekombináns neisseria meningitidis b csoport fhbp fúziós fehérje, rekombináns neisseria meningitidis b csoport nada fehérje, rekombináns neisseria meningitidis b csoport nhba fúziós fehérje - meningitis, meningococcal - meningococcus vakcinák - aktív immunizálás a neisseria meningitidis serogroup-b törzsek által okozott invazív betegség ellen.

Hexyon الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

hexyon

sanofi pasteur europe - filamentous haemagglutinin, haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate), hepatitis b surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (mahoney strain) produced on vero cells, poliovirus (inactivated) type 2 (mef-1 strain) produced on vero cells, poliovirus (inactivated) type 3 (saukett strain) produced on vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, diphtheria toxoid - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - a vakcinák - hexyon (dtap-ipv-hb-hib) javallt elsődleges és emlékeztető oltás a csecsemők és a kisgyermekek hat hét-ból kor a diftéria, tetanusz, pertussis, hepatitis b, poliomyelitis és invazív betegségek okozta haemophilus influenzae b típus (hib). használja ezt a vakcinát a hivatalos ajánlásoknak megfelelően.

Infanrix Hexa الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

infanrix hexa

glaxosmithkline biologicals s.a. - diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis b surface antigen, poliovirus (inactivated) (type-1 (mahoney strain), type-2 (mef-1 strain), type-3 (saukett strain)), haemophilus influenzae type b polysaccharide - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - a vakcinák - infanrix hexa javallott elsődleges és emlékeztető oltás csecsemők diftéria, tetanusz, pertussis, hepatitis b, poliomyelitis és betegség okozta haemophilus influenzae b-típus.

Qtern الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

qtern

astra zeneca ab - saxagliptin, dapagliflozin propándiol-monohidrát - diabetes mellitus, type 2; diabetes mellitus; nutritional and metabolic diseases; metabolic diseases; glucose metabolism disorders - cukorbetegségben szedett gyógyszerek - qtern, fix dózisú kombináció saxagliptin, dapagliflozin, javallt felnőtteknél a 18 éves vagy idősebb, a 2-es típusú cukorbetegség:javítani a glikémiás kontroll, ha metforminnal és/vagy szulfonilureával (su), illetve a monocomponents a qtern nem nyújt megfelelő glikémiás kontroll,amikor már kezelik a szabad kombinációja dapagliflozin, saxagliptin. (lásd 4. 2, 4. 4, 4. 5. és 5. sz. 1 a rendelkezésre álló adatok a vizsgált kombinációk.

Vaxelis الاتحاد الأوروبي - الهنغارية - EMA (European Medicines Agency)

vaxelis

mcm vaccine b.v. - diftéria toxoidot tartalmazza, tetanusz toxoid, bordetella pertussis antigének: pertussis toxoid, rákok fonalas hemagglutinin, pertactin, fimbriae típusú, 2, 3, hepatitis b felületi antigén élesztősejtekben, poliovírus (inaktivált): írja be az 1 (mahoney), írja be a 2 (mef-1), 3-as típusú (saukett) előállított vero sejt/ b-típusú haemophilus influenzae poliszacharid (polyribosylribitol foszfát) konjugált meningococcus fehérje. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - a vakcinák - vaxelis (dtap-hb-ipv-hib) javallt elsődleges és emlékeztető oltás a csecsemők és a kisgyermekek, 6 hetes kortól diftéria, tetanusz, pertussis, hepatitis b, poliomyelitis és invazív betegségek okozta haemophilus influenzae b típus (hib). a vaxelis használatának összhangban kell lennie a hivatalos ajánlásokkal.