Unjoni Ewropea - Malti - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - lopinavir, ritonavir - infezzjonijiet ta 'hiv - antivirals for systemic use, protease inhibitors - kaletra huwa indikat flimkien ma 'prodotti mediċinali antiretrovirali oħra għat-trattament ta' adulti infettati bil-virus tal-immunodefiċjenza umana (hiv-1), adolexxenti u tfal ta '14-il jum jew aktar. l-għażla ta 'kaletra għall-kura ta' impedituri protease tal-hiv-1 f'pazjenti infettati għandha tkun ibbażata fuq testijiet tar-reżistenza virali u l-istorja tat-trattament tal-pazjenti.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulina glargine - diabetes mellitus - drogi użati fid-dijabete - trattament tad-dijabete mellitus f'adulti, adolexxenti u tfal ta 'sentejn u aktar.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - pegfilgrastim - newtropenja - immunostimulanti, - tnaqqis fit-tul tal-neutropenia u l-inċidenza tal-marda bid-deni neutropenia fil-pazjenti adulti ttrattati ċitotossiċi chemotherapy għall-malignancy (bl-eċċezzjoni ta ' kronika myeloid lewċemja u myelodysplastic sindromi).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

theravance biopharma ireland umited - telavancin - pneumonia, bacterial; cross infection - antibatteriċi għal użu sistemiku, - vibativ huwa indikat għat-trattament ta ' l-adulti bl-pnewmonja nosokomjali inklużi ventilaturi assoċjati pnewmonja, magħrufa jew issuspettat li jkun ikkawżat mill-awrei-reżistenti staphylococcus aureus (mrsa). vibativ għandu jintuża biss f'sitwazzjonijiet fejn huwa magħruf jew hemm suspett li l-alternattivi oħra mhumiex adattati. għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu xieraq ta ' sustanzi antibatteriċi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited  - pazopanib - karċinoma, Ċellula renali - aġenti antineoplastiċi - tal-kliewi-karċinoma taċ-ċellola (rcc)votrient huwa indikat fl-adulti għall-ewwel linja ta ' trattament ta avvanzat tal-kliewi-karċinoma taċ-ċellola (rcc) u għall-pazjenti li rċevew terapija minn qabel b'ċitokini għal marda avvanzata. sarkoma tat-tessuti rotob (sts)votrient huwa indikat għall-kura ta 'pazjenti adulti b'selettiv sottotipi ta' sarkoma tat-tessuti rotob (sts) u li jkunu ħadu l-kimoterapija qabel, għal mard metastatiku jew li għamlu progress fi żmien 12-il xahar ta'wara (neo)terapija miżjuda. l-effikaċja u s-sigurtà għandhom biss ġewx stabbiliti f'ċerti sts istoloġika tat-tumur sottotipi.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - mercaptamine bitartrate - Ċistinosi - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - procysbi huwa indikat għat-trattament ta 'ċistinosi nefropatika ppruvata. cysteamine jnaqqas l-akkumulazzjoni taċ-ċistina f'xi ċelluli (e. lewkoċiti, iċ-ċelloli tal-muskoli u l-fwied) tal-pazjenti nephropathic cystinosis u, meta t-trattament jibda kmieni, huwa dewmien l-iżvilupp tal-falliment renali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

therakind (europe) limited - methotrexate - arthritis, psoriatic; precursor cell lymphoblastic leukemia-lymphoma; psoriasis; arthritis, rheumatoid; arthritis - aġenti antineoplastiċi - fl-rheumatological u dermatoloġiċi diseasesactive ' l-artrite rewmatika f'pazjenti adulti. polyarthritic forom severi, attivi-artrite idjopatika ġuvenili (jia) fl-adoloxxenti u tfal b'età minn 3 snin u l-fuq minn meta r-rispons għal mediċini mhux sterojdi kontra l-infjammazzjoni (nsaids), kienet inadegwata. severi, it-trattament refrattarji, diżabilità tal-psorijasi u li ma jirrispondix biżżejjed għall-forom oħra ta ' kura bħal fototerapija, psoralen u mir-radjazzjoni ultravjola (puva) it-terapija u l-retinojdi, u severa l-artrite psorjatika f'pazjenti adulti. fl-oncologymaintenance-trattament ta ' lewkimja akuta limfoblastika (all) fl-adulti, l-adoloxxenti u t-tfal b'età minn 3 snin u aktar.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

immedica pharma ab - glycerol phenylbutyrate - disturbi taċ-Ċiklu ta 'l-urea, inborn - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - ravicti huwa indikat għall-użu bħala terapija aġġuntiva għall-kroniku tal-ġestjoni ta 'pazjenti bil-urea disturbi fiċ-ċiklu (ucds) inklużi n-nuqqasijiet tal-carbamoyl phosphate-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinate synthetase (ass), argininosuccinate lyase (asl), arginase i (arg) u ornithine translocase defiċjenza hyperornithinaemia-iperammonemija homocitrullinuria sindromu (hhh) li ma jistgħux ikunu ġestiti mill-restrizzjoni ta' proteini tad-dieta u/jew l-aċidu amminiku supplimentazzjoni waħdu. ravicti għandhom jiġu użati mal-restrizzjoni ta ' proteini tad-dieta u, f'xi każijiet, supplimenti tad-dieta (e. , amino acids essenzjali, arginine, citrulline, supplimenti ta 'kaloriji mingħajr proteini).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck europe b.v.  - interferon beta-1a - sklerosi multipla - immunostimulanti, - rebif hu indikat għall-kura ta': pazjenti b'avveniment wieħed demyelinating bi proċess infjammatorju attiv, jekk dijanjosi alternattivi kienu esklużi, u jekk kien stabbilit li huma f'riskju għoli li jiżviluppaw sklerożi multipla klinikament definita;il-pazjenti li jkollhom sklerożi multipla reċidiva. fi provi kliniċi, dan ġie karaterizzat jew aktar l-aggravament akut fil-sentejn preċedenti. l-effikaċja ma ntwerietx f'pazjenti bi sklerożi multipla progressiva sekondarja mingħajr għaddejjin irkadar.