European Union - Maltese - EMA (European Medicines Agency)

takeda manufacturing austria ag - impeditur c1 (uman) - angioedemas, ereditarji - c1-inibitur, derivat mill-plażma, mediċini wżati fil anġjoedema ereditarja - trattament u prevenzjoni ta 'attakki ta' anġjoedema f'adulti, adolexxenti u tfal (sentejn u aktar) b'anġjoedema ereditarja (hae). rutina għall-prevenzjoni ta'l-attakki tal-anġjoedema fl-adulti, l-adoloxxenti u t-tfal (6 snin u l-fuq) bil-qawwi u rikorrenti l-attakki ta 'anġjodemija ereditarja (hae), li huma intolleranti għal, jew mhux biżżejjed protetti mill-ħalq l-prevenzjoni tal-trattamenti, jew pazjenti li mhumiex adegwatament ġestiti bl-ripetuti ta' kura akuta.

European Union - Maltese - EMA (European Medicines Agency)

acino ag - clopidogrel - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - aġenti antitrombotiċi - clopidogrel is indicated in adults for the prevention of atherothrombotic events in: , , , patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease, non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa), st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy, patients suffering from acute coronary syndrome. , ,.

European Union - Maltese - EMA (European Medicines Agency)

actavis group ptc ehf - oseltamivir - influwenza, bniedem - antivirals for systemic use, neuraminidase inhibitors - it-trattament tal-influenzain pazjenti minn sena'l fuq li jkollhom is-sintomi tipiċi ta'l-influwenza, meta l-virus ta'l-influwenza qiegħed jinfirex fil-komunità. ebilfumin huwa indikat għall-kura ta 'trabi ta' anqas minn sena 1 ta ' età waqt l-influwenza pandemika l-alkoħol (ara sezzjoni 5. 2 tal-smpc). - tabib li qed jikkura għandha tieħu in kunsiderazzjoni l-patoġeniċità tal-ċirkolazzjoni-razza u l-bażi tal-kundizzjoni tal-pazjent sabiex jiġi żgurat li hemm il-potenzjal tal-benefiċċju li l-wild. il-prevenzjoni ta influenzapost-espożizzjoni għall-prevenzjoni fil-individwi sena 1 ta ' l-età jew fuq wara li jkollhom kuntatt ma'każ ta'influwenza ddijanjostikat klinikament meta l-virus ta'l-influwenza qiegħed jinfirex fil-komunità. l-użu xieraq ta ebilfumin għall-prevenzjoni ta'l-influwenza għandu jiġi determinat fuq bażi ta'każ b'każ mill-ċirkustanzi u l-popolazzjoni li teħtieġ il-protezzjoni. f'sitwazzjonijiet eċċezzjonali (e. fil-każ ta'nuqqas ta'qbil bejn il-ċirkulazzjoni u l-virus tal-vaċċin razez, u f'sitwazzjoni pandemika) ta'prevenzjoni fl-istaġun tista'tiġi kkunsidrata f'individwi minn sena jew akbar fl-età. ebilfumin huwa indikat għall-prevenzjoni wara espożizzjoni ta 'l-influwenza fit-trabi ta' anqas minn sena 1 ta ' età waqt l-influwenza pandemika l-alkoħol (ara sezzjoni 5. 2 tal-smpc). ebilfumin mhux sostitut għal tilqima kontra l-influwenza.

European Union - Maltese - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - idursulfase - mucopolysaccharidosis ii - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - elaprase huwa indikat għall-kura fit-tul ta ' pazjenti bl-kaċċatur syndrome (mucopolysaccharidosis ii, mps ii). in-nisa eterozigoti ma ġewx studjati fil-provi kliniċi.

European Union - Maltese - EMA (European Medicines Agency)

hexal ag - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - immunostimulanti, - tnaqqis fid-dewmien ta 'newtropenja u l-inċidenza ta' newtropenja bid-deni f'pazjenti kkurati b'kimoterapija ċitotossika stabbilita għal malinn (bl-eċċezzjoni ta 'lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat-tnaqqis fid-dewmien ta' newtropenja f'pazjenti li jkollhom terapija majeloablattiva segwita mill-għadam-trapjant tal-mudullun kkunsidrati li jkunu f'riskju akbar fit-tul ta ' newtropenja severa. is-sigurtà u l-effikaċja ta 'filgrastim huma simili fl-adulti u fit-tfal li qed jirċievu kimoterapija ċitotossika. il-mobilizzazzjoni ta ' ċelluli proġenituri tad-demm (pbpcs). fit-tfal u fl-adulti bi ħsara severa konġenitali, ċiklika, jew newtropenja idjopatika bl-għadd assolut ta 'newtrofili (anc) ta' ≤ 0. 5 x 109/l, u storja ta severi jew infezzjonijiet rikorrenti, l-għoti fit-tul ta 'filgrastim hu indikat biex iżid l-għadd tan-newtrofili u biex inaqqas l-inċidenza u t-tul ta' l-infezzjoni avvenimenti relatati mal-. il-kura ta ' newtropenja persistenti (anc ≤ 0. 5 x 109/l), u storja ta'reazzjonijiet severi jew infezzjonijiet rikorrenti, l-għoti fit-tul ta 'filgrastim hu indikat biex iżid l-għadd tan-newtrofili u biex inaqqas l-inċidenza u t-tul ta' l-infezzjoni avvenimenti relatati mal-. fil-pazjenti b'infezzjoni avvanzata tal-hiv, sabiex jitnaqqas ir-riskju ta ' infezzjonijiet batterjali meta għażliet terapewtiċi oħrajn ma jkunux adattati.

European Union - Maltese - EMA (European Medicines Agency)

takeda pharmaceuticals international ag - icatibant - angioedemas, ereditarji - terapija kardijaka - firazyr huwa indikat għal kura sintomatika ta 'attakki akuti ta' anġjoedema ereditarja (hae) f'adulti (b'defiċjenza ta 'inibitur ta' c1-esterase).

European Union - Maltese - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - guanfacine hydrochloride - tnaqqis tad-defiċit ta 'l-attenzjoni b'hérapectivity - antiadrenergic agents, centrally acting, antihypertensives, - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective. intuniv għandhom ikunu użati bħala parti minn komprensiva adhd-programm tat-trattament, tipikament inkluż psikoloġiċi, l-edukazzjoni u l-miżuri soċjali.

European Union - Maltese - 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.

European Union - Maltese - EMA (European Medicines Agency)

bayer ag - telmisartan - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - hypertensiontreatment ta'l-ipertensjoni essenzjali fl-adulti. kardjovaskulari preventionreduction tal-morbidità kardjovaskulari f'pazjenti bi: - manifest aterotrombotiċi mard kardjovaskulari (passat ta ' mard koronarju tal-qalb, puplesija, jew mard arterjali periferali) jew;dijabete tat-tip 2 mellitus dokumentata-mira-ħsara fl-organi.

European Union - Maltese - EMA (European Medicines Agency)

bayer ag  - vardenafil - disfunzjoni erettili - uroloġiċi - trattament ta 'disfunzjoni erettili f'irġiel adulti. id-disfunzjoni erettili hija l-inkapaċità li tinkiseb jew tinżamm erezzjoni tal-pene suffiċjenti għal prestazzjoni sesswali sodisfaċenti. biex levitra ikun effettiv, hija meħtieġa stimulazzjoni sesswali. levitra mhux indikat għall-użu min-nisa.