Europeiska unionen - maltesiska - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - aġenti antitrombotiċi - prevenzjoni ta ' l-thromboembolism venous (vte) fil-pazjenti adulti li għaddejjin minn elettiva għadma jew irkoppa sostituzzjoni kirurġija. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 for haemodynamically unstable pe patients. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 għall-emodinamikament instabbli pe pazjenti). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 u 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. trattament ta 'trombożi f' vina fonda (dvt) u emboliżmu pulmonari (pe), u l-prevenzjoni tar-rikorrenti dvt u pe fl-adulti. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Europeiska unionen - maltesiska - EMA (European Medicines Agency)

bayer ag - riociguat - pressjoni għolja, pulmonari - antihypertensives għall-ipertensjoni arterjali pulmonari - chronic thromboembolic pulmonary hypertension (cteph)adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah)adultsadempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. l-effikaċja ġiet murija fil-pah popolazzjoni inklużi l-etjoloġiji ta idjopatika jew li tintiret-pah jew pah assoċċjata ma'mard tal-connective tissue. paediatricsadempas is indicated for the treatment of pah in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with who functional class (fc) ii to iii in combination with endothelin receptor antagonists.

Europeiska unionen - maltesiska - EMA (European Medicines Agency)

teva pharma b.v. - docetaxel - carcinoma, non-small-cell lung; breast neoplasms; prostatic neoplasms - aġenti antineoplastiċi - tas-sider cancerdocetaxel teva pharma monoterapija hija indikata għat-trattament ta 'pazjenti b'lokalment avvanzat jew tal-kanċer tas-sider metastatiku wara l-falliment ta' terapija ċitotossika. kemjoterapija preċedenti kellha tinkludi anthracycline jew aġent alkilanti. mhux żgħar tal-pulmun taċ-ċelluli cancerdocetaxel teva pharma huwa indikat għall-kura ta ' pazjenti b'lokalment avvanzat jew dak metastatiku li mhux żgħar tal-pulmun taċ-ċelloli tal-kanċer wara l-falliment tal-kimoterapija qabel. docetaxel teva pharma flimkien ma 'cisplatin huwa indikat għat-trattament ta' pazjenti li ma jistax jitneħħa, avvanzat lokalment jew dak metastatiku li mhux żgħar tal-pulmun taċ-ċelluli tal-kanċer, f'pazjenti li ma kinux ħadu qabel terapija ċitotossika għal din il-kundizzjoni. - prostata cancerdocetaxel teva pharma flimkien ma 'prednisone jew prednisolone huwa indikat għat-trattament ta' pazjenti bl-ormon tat-refrattarji kanċer metastatiku tal-prostata.

Europeiska unionen - maltesiska - EMA (European Medicines Agency)

merck sharp dohme limited - lamivudine, raltegravir potassju - infezzjonijiet ta 'hiv - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis huwa indikat f ' għaqda ma ' oħrajn anti‑retroviral prodotti mediċinali għat-trattament ta ' l-infezzjoni tal-virus ta ' immunodefiċjenza umani (hiv‑1) fl-adulti, adolixxenti u tfal mill-età ta ' 6 snin u mill-anqas 30 kg mingħajr preżent użin jew imgħoddi evidenza ta ' reżistenza virali għal aġenti antivirali tal-insti (integrase il-faxxa trasferiment inhibitor) u nrti (inibitur ta ' rivers transcriptase nukleosidi) klassijiet (ara sezzjonijiet 4. 2, 4. 4 u 5.

Europeiska unionen - maltesiska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - aprepitant - vomiting; postoperative nausea and vomiting; cancer - anti-emetiċi u anti-nawżjanti, - emend 40 mg kapsuli iebsin huwa indikat għall-prevenzjoni ta 'nawżea u rimettar (ponv) wara l-operazzjoni fl-adulti. emend huwa disponibbli wkoll bħala 80 mg u 125 mg kapsuli iebsin għall-prevenzjoni ta'nawseja u rimettar assoċjati ma'ħafna u kimoterapija tal-kanċer moderatament emetoġenika fl-adulti u fl-adolexxenti mill-età ta ' 12-il (ara separati sommarju tal-karatteristiċi tal-prodott). emend huwa disponibbli wkoll bħala 165 mg kapsuli iebsin għall-prevenzjoni ta akuta u ttardjata dardir u r-rimettar assoċjati mal ferm emetoġenika bbażata fuq cisplatin kimoterapija tal-kanċer fl-adulti u l-prevenzjoni ta'nawseja u rimettar assoċjati ma'kimoterapija tal-kanċer moderatament emetoġenika fl-adulti. emend huwa wkoll disponibbli bħala trab għal suspensjoni orali għall-prevenzjoni ta'nawseja u rimettar assoċjati ma'ħafna u moderatament emetoġenika kimoterapija tal-kanċer fit-tfal, tfal żgħar u trabi mill-età ta ' 6 xhur u inqas minn 12-il sena. emend 80 mg, 125 mg, 165 mg kapsuli iebsin u emend trab għal suspensjoni orali qed jingħata bħala parti minn terapija ta'kombinazzjoni.

Europeiska unionen - maltesiska - 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 - 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.

Europeiska unionen - maltesiska - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - ritonavir - infezzjonijiet ta 'hiv - antivirali għal użu sistemiku - ritonavir huwa indikat flimkien ma 'aġenti antiretrovirali oħra għall-kura ta' pazjenti infettati bl-hiv-1 (adulti u tfal ta 'sentejn u akbar).

Europeiska unionen - maltesiska - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sonidegib difosfat - karċinoma, Ċellula basal - aġenti antineoplastiċi - odomzo huwa indikat għat-trattament ta 'pazjenti adulti b'karċinoma taċ-ċelluli bażali lokalment avvanzati (bcc) li mhumiex suġġetti għal kirurġija ta' kura jew terapija bir-radjazzjoni.

Europeiska unionen - maltesiska - EMA (European Medicines Agency)

accord healthcare s.l.u. - voriconazole - aspergillosis; candidiasis; mycoses - antimikotiċi għall-użu sistemiku-derivattivi tat-triazole - voriconazole huwa aġent broad-spectrum, aġent antifungali triazole u hija indikata fl-adulti u t-tfal li għandhom sentejn u aktar kif ġej:trattament ta 'asperġillożi invażiva;it-trattament ta'candidaemia f'pazjenti mhux newtropeniċi;il-kura ta' fluconazole-'infezzjonijiet invażivi serji candida reżistenti (inkluż c. krusei);il-kura ta'infezzjonijiet fungali serji kkawżati minn scedosporium spp. u fusarium spp. voriconazole għandu jingħata primarjament lil pazjenti b'progressiva, possibbilment ta'theddida għall-ħajja infezzjonijiet.

Europeiska unionen - maltesiska - EMA (European Medicines Agency)

janssen-cilag international nv - simeprevir - epatite Ċ, kronika - antivirali għal użu sistemiku - olysio huwa indikat flimkien ma 'prodotti mediċinali oħra għall-kura ta' l-epatite Ċ kronika (chc) f'pazjenti adulti. għall-vajrus tal-epatite Ċ (hcv) ġenotip attività speċifika.