Uniunea Europeană - română - EMA (European Medicines Agency)

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 - agenți antineoplazici - 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. pacienții cu egfr sau alk pozitiv de tumoră mutații ar trebui să, de asemenea, au primit terapie vizate înainte de a primi 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.

Uniunea Europeană - română - EMA (European Medicines Agency)

merck sharp & dohme b.v.  - virusul rujeolei enders' edmonston tulpina (viu atenuat), virusul oreionului jeryl lynn (nivel b) tulpina (viu atenuat), virusul rubeolei wistar ra 27/3 tulpina (viu atenuat) - rubella; mumps; immunization; measles - vaccinuri - m-m-rvaxpro este indicat pentru vaccinarea simultană împotriva rujeolei, oreionului și rubeolei la persoane fizice 12 luni sau mai mari. pentru utilizarea în timpul epidemiilor de rujeolă, sau pentru vaccinarea după expunere, sau pentru utilizarea în prealabil nevaccinate copii mai mari de 12 luni, care sunt în contact cu femei gravide susceptibile, și persoane susceptibile de a oreionului și rubeolei.

Uniunea Europeană - română - EMA (European Medicines Agency)

ology bioservices ireland ltd - virusul gripal (întreg virion, inactivat), conținând antigen de: a/vietnam/1203/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaccinuri pentru gripă - imunizarea activă împotriva subtipului h5n1 al virusului gripal a. această indicație se bazează pe imunogenitate date de subiecți la vârsta de 6 luni începând de la administrarea a două doze de vaccin preparat cu subtipul h5n1 tulpini. vepacel ar trebui să fie utilizate în conformitate cu recomandările oficiale.

Uniunea Europeană - română - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - hepatitis a virus (inactivated), hepatitis b surface antigen - immunization; hepatitis b; hepatitis a - vaccinuri - twinrix pediatric este indicat pentru utilizare la sugari neimuneri, copii și adolescenți cu vârsta cuprinsă între un an și până la 15 ani, care prezintă risc de infecție cu hepatită a și hepatită b.

Uniunea Europeană - română - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - virusul virusului gripei inactivat, care conține antigen echivalent cu tulpina derivată a / california / 07/2009 (h1n1) utilizată nymc x-179a - influenza, human; immunization; disease outbreaks - vaccinuri pentru gripă - profilaxia gripei cauzate de un virus v 2009 (h1n1). pandemrix trebuie utilizat numai în cazul în care nu există vaccinuri recomandate pentru gripa sezonieră trivalent / quadrivalent anuale şi dacă imunizarea impotriva (h1n1) v este necesar (a se vedea secțiunile 4. 4 și 4. pandemrix ar trebui să fie utilizate în conformitate cu recomandările oficiale.

Uniunea Europeană - română - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - virusul gripei de suprafață (hemaglutinină și neuraminidază) de tulpina a / vietnam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaccinuri - imunizarea activă împotriva subtipului h5n1 al virusului gripal a. , , this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain. , , prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

Uniunea Europeană - română - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - a / indonezia / 05/2005 (h5n1) ca tulpina folosită (pr8-ibcdc-rg2) - influenza, human; immunization; disease outbreaks - vaccinuri - imunizarea activă împotriva subtipului h5n1 al virusului gripal-a. această indicație se bazează pe imunogenitate date de la subiecți sănătoși cu vârsta de 18 ani, începând de la administrarea a două doze de vaccin preparat cu subtipul h5n1 tulpini. prepandrix ar trebui să fie utilizate în conformitate cu recomandările oficiale.

Uniunea Europeană - română - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a.  - vaccin gripal pandemic (h5n1) (virion fragmentat, inactivat, cu adjuvant) - influenza, human; immunization; disease outbreaks - vaccinuri - profilaxia gripei într-o situație pandemică declarată oficial. pandemie de gripa vaccin ar trebui să fie utilizate în conformitate cu recomandările oficiale.

Uniunea Europeană - română - EMA (European Medicines Agency)

merck sharp dohme ltd - papilomavirus uman tip 6, proteina l1, papilomavirus uman tip 11 proteina l1, papilomavirus uman de tip 16 proteina l1, papilomavirus uman tip 18 proteina l1 - papillomavirus infections; uterine cervical dysplasia; condylomata acuminata; immunization - vaccinuri - silgard este un vaccin utilizat la vârsta de 9 ani pentru prevenirea:leziuni genitale precanceroase (cervicale, vulvare și vaginale), premaligne leziunilor anale, cancer de col uterin și cancer anal cauzal legate de anumite oncogene de papilomavirus uman (hpv), tipurile;veruci genitale (condyloma acuminata) cauzal legate de anumite tipuri de hpv. vezi secțiunile 4. 4 și 5. 1 pentru informații importante privind datele care susțin această indicație. utilizarea de silgard ar trebui să fie în conformitate cu recomandările oficiale.

Uniunea Europeană - română - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - imunosupresoare - consultați secțiunea 4. 1 din rezumatul caracteristicilor produsului în documentul cu informații despre produs.