Aubagio European Union - Maltese - EMA (European Medicines Agency)

aubagio

sanofi winthrop industrie - teriflunomide - sklerosi multipla - immunosuppressanti selettivi - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Eylea European Union - Maltese - EMA (European Medicines Agency)

eylea

bayer ag - aflibercept - wet macular degeneration; macular edema; diabetes complications - oftalmoloġiċi - eylea huwa indikat għall-adulti għat-trattament ta': neovaskulari (imxarrba) relatata mal-età deġenerazzjoni makulari (amd);indeboliment tal-vista minħabba l-edima makulari sekondarja għal okklużjoni tal-vina tar-retina (il-fergħa rvo jew ċentrali rvo);indeboliment tal-vista minħabba ta 'edima makulari dijabetika (dme);indeboliment tal-vista minħabba myopic ġrieħi ta' neovaskularizzazzjoni korojdali (myopic cnv).

Fasturtec European Union - Maltese - EMA (European Medicines Agency)

fasturtec

sanofi winthrop industrie - rasburicase - iperurċemija - il-prodotti terapewtiċi l-oħra kollha - it-trattament u l-profilassi ta ' hyperuricaemia akuta, sabiex jiġi evitat falliment renali akuta, fl-adulti, tfal u adolexxenti (età 0 sa 17 snin) ma malignancy ħematoloġiċi mal-piż tumur għolja u f'riskju tumur rapida lysis jew jinxtorob fil bidu ta ' l-chemotherapy.

Hexacima European Union - Maltese - EMA (European Medicines Agency)

hexacima

sanofi pasteur - hepatitis b surface antigen, diphtheria toxoid, tetanus toxoid, bordetella pertussis antigens pertussis toxoid filamentous haemagglutinin, poliovirus (inactivated) type 1 (mahoney) type 2 (mef-1) type 3 (saukett), haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein - hepatitis b; tetanus; immunization; meningitis, haemophilus; whooping cough; poliomyelitis; diphtheria - vaccines, bacterial and viral vaccines, combined - hexacima (dtap-ipv-hb-hib) huwa indikat għat-tilqim primarja u booster tat-trabi u toddlers minn sitt ġimgħat ta ' età kontra diphtheria, tetanus, pertussis, epatite b, poliomyelitis u invażivi mard ikkawżat minn influwenza Ħemofillika tip b (hib). l-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Hexyon European Union - Maltese - 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 - vaċċini - hexyon (dtap-ipv-hb-hib) huwa indikat għat-tilqim primarja u booster tat-trabi u toddlers minn sitt ġimgħat ta ' età kontra diphtheria, tetanus, pertussis, epatite b, poliomyelitis u invażivi mard ikkawżat minn influwenza Ħemofillika tip b (hib). l-użu ta ' dan il-vaċċin għandha tkun skond ir-rakkomandazzjonijiet uffiċjali.

Ecoporc Shiga European Union - Maltese - EMA (European Medicines Agency)

ecoporc shiga

ceva santé animale - organiżmi ġenetikament modifikati rikombinanti shiga-tossina-2c-antiġen - immunologicals for suidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - majjali - immunizzazzjoni attiva ta 'qżieqeż mill-età ta' erbat ijiem, biex titnaqqas il-mortalità u sinjali kliniċi ta ' edima l-mard ikkawżat mill-shiga-tossina 2c prodotti minn escherichia coli (stec). il-bidu tal-immunità: 21 jum wara t-tilqima. tul ta 'żmien ta' l-immunità: 105 jum wara t-tilqima.

Gripovac 3 European Union - Maltese - EMA (European Medicines Agency)

gripovac 3

merial s.a.s.  - l-influwenza inattivat tal-virus, tal-ħnieżer - immunoloġiċi - majjali - immunizzazzjoni attiva tal-ħnieżer mill-età ta ' 56 jum'il quddiem inklużi nisa tqal-majjali kontra l-influwenza tal-ħnieżer kkawżata mill-sottotipi h1n1, h3n2 u h1n2 biex tnaqqas sinjali kliniċi u l-viral-pulmun tat-tagħbija wara l-infezzjoni. il-bidu tal-immunità: 7 ijiem wara t-tilqima primarja. tul ta 'żmien tal-immunità: 4 xhur f'ħnieżer imlaqqma bejn l-età ta' 56 u 96 jum u 6 xhur f'ħnieżer imlaqqma għall-ewwel darba f'96 ġurnata u aktar. immunizzazzjoni attiva tal-ħnieżer nisa tqal wara l-lest ta 'immunizzazzjoni primarja mill-għoti ta' doża waħda 14-il jum qabel ma l-ħanżira tferragħ li jiżviluppaw għolja colostral-immunità li jipprovdi protezzjoni klinika tal-qżieqeż għal mill-inqas 33 jum wara t-twelid.

Hiprabovis IBR Marker Live European Union - Maltese - EMA (European Medicines Agency)

hiprabovis ibr marker live

laboratorios hipra s.a - virus ħaj tal-virus tal-herpes tal-ifrat imħallat b'ġenet doppju tip 1, razza ceddel: 106.3-107.3 ccid50 - immunoloġiċi - bhejjem - għal-immunizzazzjoni attiva tal-bhejjem mill-età ta 'tliet xhur kontra l-bovini virus herpes tat-tip 1 (bohv-1) biex jitnaqqsu s-sinjali kliniċi ta' infectious bovine rhinotracheitis (ibr) u l-eskrezzjoni tal-virus fil-qasam. il-bidu tal-immunità: 21 jum wara t-tlestija tal-iskema bażika tat-tilqim. tul ta 'żmien tal-immunità: 6 xhur wara t-tkomplija tal-iskema bażika tat-tilqim.

Keytruda European Union - Maltese - 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 - aġenti antineoplastiċi - 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. pazjenti b'egfr jew alkalini pożittivi tat-tumur mutazzjonijiet għandu wkoll rċevew terapija immirata qabel ma tirċievi 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.

Lartruvo European Union - Maltese - EMA (European Medicines Agency)

lartruvo

eli lilly nederland b.v. - olaratumab - sarcoma - aġenti antineoplastiċi - lartruvo hija indikata fil kombinazzjoni ma ' doxorubicin għat-trattament tal-pazjenti adulti b ' sarcoma artab avvanzati tat-tessuti li m'humiex soġġetti għal trattament kurattivi bil-kirurġija jew radjoterapija u li ma ġewx qabel trattati b ' doxorubicin (ara taqsima 5.