Unjoni Ewropea - Malti - EMA (European Medicines Agency)

novartis europharm limited - rivastigmine - alzheimer disease; parkinson disease; dementia - psychoanaleptics, - trattament sintomatiku ta 'dimenzja ta' alzheimer ħafifa għal moderatament gravi. kura sintomatika ta 'minn ħafifa għal moderatament gravi dimenzja f'pazjenti bil-marda idjopatika ta' parkinson.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - glasdegib maleate - lewkimja, mijelojda, akuta - aġenti antineoplastiċi - daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (aml) in adult patients who are not candidates for standard induction chemotherapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - orlistat - obeżità - preparazzjonijiet ta 'kontra l-ossessjoni, esklużi prodotti tad-dieta - alli huwa ndikat għal telf tal-piż f'adulti b'piż żejjed (indiċi tal-massa tal-ġisem, bmi ≥ 28 kg/m2) u li għandhom jittieħdu flimkien ma'b'kaloriji kemmxejn baxxi, inqas xaħam.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

amgen europe b.v. - darbepoetin alfa - anemia; cancer; kidney failure, chronic - oħra antianemic preparazzjonijiet - kura ta 'anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (crf) f'adulti u pazjenti pedjatriċi. kura ta ' anemija sintomatika f'pazjenti adulti bil-kanċer tumuri malinni mhux majelojdi li qed jirċievu l-kimoterapija.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sanofi b.v. - eliglustat - mard gaucher - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - cerdelga huwa indikat għall-fit-tul it-trattament tal-pazjenti adulti ma gaucher il-marda tat-tip 1 (gd1), li huma metabolisers fqir cyp2d6 (pms), metabolisers intermedjarji (ims) jew metabolisers estensiva (ems).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - interferon alfa-2b - carcinoid tumor; leukemia, hairy cell; lymphoma, follicular; hepatitis b, chronic; hepatitis c, chronic; leukemia, myelogenous, chronic, bcr-abl positive; melanoma; multiple myeloma - immunostimulanti, - - epatite kronika btreatment ta 'pazjenti adulti bl-epatite b kronika assoċjata ma 'evidenza ta' l-epatite b r-replikazzjoni virali (il-preżenza tal-dna ta 'l-epatite b virus (ta' l-hbv-dna) u l-epatite b, l-antiġen (hbeag), livelli elevati ta ' alanine aminotransferase (alt) u istoloġikament ippruvat attiva tal-fwied u infjammazzjoni u / jew fibrożi. - epatite kronika cbefore-bidu tat-trattament b'introna, għandu jiġi kkunsidrat li r-riżultati mill-provi kliniċi li qabblu introna ma ' interferon. adulti patientsintrona huwa indikat għall-kura ta ' pazjenti adulti b'epatite Ċ kronika li għandhom transaminases elevati mingħajr dikompensazzjoni tal-fwied u li huma pożittivi għall-epatite c-virus tal-rna (hcv-rna). l-aħjar mod kif tuża introna f'din l-indikazzjoni huwa flimkien ma ' ribavirin. tfal minn tliet snin 'il fuq u adolescentsintrona huwa indikat, f'kors ta 'kombinazzjoni ma' ribavirin, għall-kura ta ' tfal minn tliet snin jew akbar u adolexxenti, li għandhom epatite Ċ kronika, li ma ġietx ikkurata qabel, mingħajr dikumpensazzjoni tal-fwied, u li huma pożittivi għall-hcv-rna. meta tiddeċiedi li ma li tipposponi it-trattament sakemm il-ħajja adulta, huwa importanti li wieħed jikkunsidra li l-terapija kombinata indotta-inibizzjoni tat-tkabbir li irriżulta fi tnaqqis fl-tul adult finali f'xi pazjenti. id-deċiżjoni li l-kura għandha tittieħed każ b'każ. hairy cell leukaemiatreatment ta ' pazjenti bil-lewkimja tal-hairy cell. kronika myelogenous leukaemiamonotherapytreatment ta ' pazjenti adulti b'philadelphia-kromożomi jew bcr/abl-traslokazzjoni pożittivi għall-lewkimja tal-mudullun kronika. l-esperjenza klinika tindika li ematoloġiku u ċitoġenetiku maġġuri / minuri rispons jinkiseb fil-maġġoranza tal-pazjenti kkurati. rispons ċitoġeniku maġġuri huwa definit mill < 34 % ph+ lewkemika ċelloli fil-mudullun tal-għadam, filwaqt li l-minuri rispons ≥ 34 %, iżda < 90 % ph+ ċelloli fil-mudullun tal -. il-kombinazzjoni therapythe-kombinazzjoni ta 'interferon alfa-2b u cytarabine (ara-c) mogħtija matul l-ewwel 12-il xahar tat-trattament ġiet murija li tiżdied b'mod sinifikanti r-rata ta ċitoġenetiku maġġuri-tweġibiet u li jtawwal b'mod sinifikanti s-sopravivenza ġenerali fuq tliet snin meta mqabbla ma' interferon alfa-2b monoterapija. multipli myelomaas terapija ta ' manteniment f'pazjenti li rnexxielhom jiksbu għal remissjoni oġġettiva (aktar minn 50% tnaqqis fil-proteina tal-majeloma) wara l-induzzjoni inizjali kimoterapija. l-esperjenza klinika attwali tindika li l-terapija ta 'manteniment b'interferon alfa-2b ittawwal il-fażi ta' stabbilità; madankollu, l-effetti fuq is-sopravivenza ġenerali ma kinux murija b'mod konklużiv. follikulari lymphomatreatment tal-għoli tal-tumur tal-limfoma follikulari bħala kura aġġuntiva għall-kombinazzjoni xierqa il-kimoterapija induttiva, bħal chop bħall-reġimen. piż ta 'tumur għoli huwa definit bħala li għandu mill-inqas wieħed minn dawn li ġejjin: goff-massa tat-tumur (> 7 cm), l-involviment ta' tliet snin jew aktar is-siti nodali (kull wieħed > 3 cm), sintomi sistematiċi (telf ta ' piż > 10 %, deni > 38°c għal aktar minn tmint ijiem, jew għaraq matul il-lejl), splenomegalija lil hinn mill-żokra, l-organu maġġur ostruzzjoni jew bil-kompressjoni-sindromu, orbitali jew epidurali-involviment, serous chronic fil-plewra, jew lewkimja. karċinojdu tumourtreatment tat-tumuri karċinojdi fin-nodi limfatiċi jew metastażi tal-fwied u ma 'sindrome karċinojde'. malinni melanomaas-kura awżiljarja f'pazjenti li huma ħielsa mill-mard wara l-kirurġija iżda li jinsabu f'riskju għoli ta ' rikorrenza, e. pazjenti b'primarju jew rikorrenti (kliniku jew patoloġiku) limfatiċi-node.

Unjoni Ewropea - Malti - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

janssen-cilag international nv - fentanyl hydrochloride - uġigħ, wara l-operazzjoni - analġeżiċi - tmexxija ta ' moderat akuta għal uġigħ qawwi tuża għall-użu fi sptar issettjar biss.

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)

roche registration gmbh - epoetin beta - kidney failure, chronic; anemia; cancer; blood transfusion, autologous - preparazzjonijiet antianemiċi - kura ta 'anemija sintomatika assoċjata ma' insuffiċjenza renali kronika (crf) f'pazjenti adulti u pedjatriċi;il-kura ta 'anemija sintomatika f'pazjenti adulti b'tumuri malinni mhux majelojdi li kienu qed jirċievu kimoterapija;tiżdied il-ġabra ta' demm awtologu minn pazjenti fi l-pre-donazzjoni-programm. l-użu tiegħu f'din l-indikazzjoni irid ikun ibbilanċjat kontra l-żieda fir-riskju rrappurtat ta ' avvenimenti tromboemboliċi. il-kura għandha tingħata biss lil pazjenti b'anemija moderata (hb 10 - 13 g/dl [6. 21 - 8. 07 mmol/l], l-ebda defiċjenza ta 'ħadid) jekk proċeduri għal preservazzjoni tad-demm mhumiex disponibbli jew mhux biżżejjed meta l-skedata kirurġija elettiva maġġuri tkun teħtieġ volum kbir ta' demm (4 jew iktar unitajiet ta ' demm għan-nisa jew 5 jew iktar unitajiet għall-irġiel).