România - română - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

human bioplazma manufacturing and trading ltd. - albuminum humanum - sol. perf. - 200g/l - singe si substituenti de singe substituenti de singe si fractiuni proteice plasmatice

Republica Moldova - română - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

human biologicals institute (a division of indian immunologicals limited)) - final bulk for rabies human monoclonal antibody - pulbere şi solvent pentru soluţie injectabilă - 2,5 iu

Uniunea Europeană - română - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - omului papillomavirus1 tip 16 proteina l1, papilomavirus uman tip 18 proteina l1 - papillomavirus infections; uterine cervical dysplasia; immunization - vaccinuri - cervarix este un vaccin pentru utilizare la vârsta de 9 ani pentru prevenirea premaligne leziunile ano-genitale (col uterin, vulvare, vaginal şi anal) şi tipuri de cancer de col uterin şi anal cauzal legate de anumite tipuri de papilomavirus uman (hpv) oncogenic. vezi secțiunile 4. 4 și 5. 1 pentru informații importante privind datele care susțin această indicație. utilizarea cervarix trebuie să fie 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)

merck sharp & dohme b.v.  - 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 - gardasil 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 gardasil ar trebui să fie în conformitate cu recomandările oficiale.

Uniunea Europeană - română - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - diabetul zaharat - medicamente utilizate în diabet - diabet zaharat în care este necesară tratamentul cu insulină. insulina umană winthrop rapidă, de asemenea, este potrivit pentru tratarea hyperglycaemic coma si cetoacidoza, precum şi pentru realizarea pre-, intra - şi stabilizare postoperatorie la pacienţii cu diabet zaharat.

Uniunea Europeană - română - EMA (European Medicines Agency)

merck sharp & dohme b.v. - vaccinul împotriva papilomavirusului uman [tipurile 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbit) - condylomata acuminata; papillomavirus infections; immunization; uterine cervical dysplasia - papilomavirus vaccinuri - gardasil 9 este indicat pentru imunizarea activă a persoanelor fizice de la vârsta de 9 ani, împotriva hpv boli:leziuni precanceroase și cancer care afectează colul uterin, vulva, vagin si anus cauzate de hpv din vaccin typesgenital negi (condyloma acuminata) determinate de anumite tipuri de hpv. vezi secțiunile 4. 4 și 5. 1 pentru informații importante cu privire la datele care susțin aceste indicații. utilizarea gardasil 9 ar trebui să fie în conformitate cu recomandările oficiale.

Uniunea Europeană - română - EMA (European Medicines Agency)

xbiotech germany gmbh - umane igg1 anticorp monoclonal specific uman interleukin-1 alfa - neoplasme colorectale - agenți antineoplazici - tratamentul cancerului colorectal metastatic.

Uniunea Europeană - română - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - medicamente utilizate în diabet - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 și 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

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.