Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig  - axitinib - karċinoma, Ċellula renali - inibituri tal-proteina kinase - inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) after failure of prior treatment with sunitinib or a cytokine.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

virbac s.a. - gentamicin sulfate, hydrocortisone aceponate, miconazole nitrate - otologicals, kortikosterojdi u antiinfectives flimkien - klieb - trattament ta 'otite esterna akuta u taħrix akut ta' otite esterna rikorrenti assoċjata ma ' bakterja suxxettibbli għal ġentamiċin u fungi suxxettibbli għal mikonażol, b'mod partikulari malassezia pachydermatis.

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)

bayer ag - telmisartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. kinzalkomb kombinazzjoni b'doża fissa (40 mg telmisartan / 12. 5 mg hydrochlorothiazide, 80 mg telmisartan / 12. 5 mg ta ' hydrochlorothiazide) hi indikata f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata sew b'telmisartan waħdu. kinzalkomb kombinazzjoni b'doża fissa (80 mg telmisartan / 25 mg hydrochlorothiazide) hi indikata f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata adegwatament fuq kinzalkomb (80 mg telmisartan / 12. 5 mg hydrochlorothiazide) jew f'pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - telmisartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. micardisplus kombinazzjoni b'doża fissa (40 mg telmisartan / 12. 5 mg hydrochlorothiazide, 80 mg telmisartan / 12. 5 mg ta ' hydrochlorothiazide) hi indikata f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata sew b'telmisartan waħdu. micardisplus kombinazzjoni b'doża fissa (80 mg telmisartan / 25 mg hydrochlorothiazide) hi indikata f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata adegwatament fuq micardisplus (80 mg telmisartan / 12. 5 mg hydrochlorothiazide) jew f'pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

ipsen pharma - somatropin - turner syndrome; dwarfism, pituitary - ormoni u analogi pitwitarji u ipotalamiċi - trattament fuq medda twila ta 'tfal bi ħsara fit-tkabbir minħabba sekrezzjoni inadegwata ta' l-ormon tat-tkabbir endoġenu. -kura fit-tul ta 'falliment tat-tkabbir assoċjat mas-sindromu ta' turner. it-trattament ta 'qabel il-puberta tfal b'falliment tat-tkabbir assoċjat ma' insuffiċjenza kronika tal-kliewi sa l-żmien tat-trapjant renali. is-sostituzzjoni tal-ormon tat-tkabbir endoġenu f'adulti b'defiċjenza tal-ormon tat-tkabbir ta ' jew fit-tfulija jew adulti bidu etjoloġija. ormon tat-tkabbir għandu jiġi kkonfermat kif suppost qabel it-trattament.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer limited - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - aġenti antineoplastiċi - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. experience with sutent as first-line treatment is limited (see section 5.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

sandoz gmbh - somatropin - turner syndrome; prader-willi syndrome; dwarfism, pituitary - ormoni u analogi pitwitarji u ipotalamiċi - trabi, tfal u adolescentsgrowth disturb minħabba tnixxija insuffiċjenti ta ' l-ormon tat-tkabbir (gh). disturb tat-tkabbir assoċjat mas-sindromu ta ' turner. disturb tat-tkabbir assoċjat ma ' insuffiċjenza kronika tal-kliewi. disturb tat-tkabbir (current height standard deviation score (sds) ta ' < -2. 5 u aġġustat tal-ġenituri sds < -1) fi tfal / adolexxenti qosra li twieldu żgħar għaż-żmien tat-tqala (sga), bil-piż tat-twelid u / jew tul taħt-2 devjazzjonijiet standard (sds), li naqsu milli juru l-catch-up tkabbir (veloċita 'tat-tul (hv) sds < 0 matul l-aħħar sena) permezz ta 'erba' snin jew iktar tard. prader-willi (pws), għat-titjib fit-tkabbir u kompożizzjoni tal-ġisem. id-dijanjosi ta 'pws għandha tkun ikkonfermata permezz ta' test ġenetiku xieraq. adultsreplacement terapija fl-adulti bl-ormon tat-tkabbir evidenti. pazjenti b'indeboliment ormon tat-tkabbir f'età adulta huma definiti bħala pazjenti b'għandhom patoloġija pitwitarja ipotalamika magħrufa u mill-inqas defiċjenza waħda magħrufa ta ' ormon pitwitarju li ma jkunx prolactin. dawn il-pazjenti għandu jkollhom test dinamiku wieħed sabiex tiġi ddijanjostikata jew eskluża defiċjenza tal-ormon tat-tkabbir. fil-pazjenti bil-tfulija-bidu iżolati gh defiċjenza (l-ebda evidenza ta assi ipotalamika-pitwitarja-marda jew irradjazzjoni kranjali), żewġ testijiet dinamiċi għandhom jiġu rakkomandati, ħlief għal dawk li jkollhom baxx insulin-like-tkabbir tal-fattur-i (igf-i) il-konċentrazzjonijiet (sds < -2) li jistgħu jkunu kkunsidrati għal test wieħed. - il-punt ta'qtugħ tat-test dinamiku għandu jkun strett.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

bayer ag - telmisartan, hydrochlorothiazide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali. pritorplus kombinazzjoni b'doża fissa (40 mg telmisartan / 12. 5 mg hydrochlorothiazide, 80mg telmisartan / 12. 5 mg ta ' hydrochlorothiazide) hi indikata f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata sew b'telmisartan waħdu. pritorplus kombinazzjoni b'doża fissa (80 mg telmisartan / 25 mg hydrochlorothiazide) hi indikata f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata adegwatament fuq pritorplus (80 mg telmisartan / 12. 5 mg hydrochlorothiazide) jew f'pazjenti li qabel kienu stabilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

krka, d.d., novo mesto - telmisartan, hydrochlorothiazide - pressjoni għolja - telmisartan u dijuretiċi - kombinazzjoni ta ' dożi fissi ta ' tolucombi (80 mg telmisartan/25 mg idrochlorothiazide) huwa indikat fl-adulti l-pressjoni tad-demm tagħhom mhix ikkontrollata b'mod adegwat dwar tolucombi 80 mg/12. 5 mg (80 mg telmisartan / 12. 5 mg hydrochlorothiazide) jew adulti li qabel kienu stabbilizzati fuq telmisartan u hydrochlorothiazide mogħtija separatament.