Euroopan unioni - latvia - EMA (European Medicines Agency)

janssen cilag international nv - seleksipags - hipertensija, plaušu slimība - antitrombotiskie līdzekļi - uptravi tiek norādīts par ilgtermiņa attieksmi pret plaušu arteriālo hipertensiju (pao) pieaugušiem pacientiem ar pvo funkcionālā klase ii – iii (fc), vai nu kombinācijas terapiju pacientiem ar endothelin receptoru antagonists (era) nepietiekami kontrolē un/vai phosphodiesterase ierakstiet 5 inhibitors (pde-5), vai kā monoterapiju, pacientiem, kuri nav šo terapiju kandidātes. efektivitāte ir redzams pao iedzīvotājiem, tostarp idiopātiska un iedzimtības pao pao, kas saistīta ar saistaudu slimības, un pao, kas saistīti ar labots vienkārši iedzimta sirds slimība,.

Euroopan unioni - latvia - EMA (European Medicines Agency)

viatris limited - aflibercept - macular edema; retinal vein occlusion; diabetic retinopathy; myopia, degenerative; diabetes complications - oftalmoloģiskie līdzekļi - yesafili is indicated for adults for the treatment ofneovascular (wet) age-related macular degeneration (amd) (see section 5. 1),visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo) (see section 5. 1),visual impairment due to diabetic macular oedema (dme) (see section 5. 1),visual impairment due to myopic choroidal neovascularisation (myopic cnv) (see section 5.

Euroopan unioni - latvia - EMA (European Medicines Agency)

pfizer europe ma eeig - estrogēni konjugēts, bazedoxifene - postmenopauze - konjugēts estrogēns un bazedoksifēns - duavive ir norādīts:Ārstēšana oestrogen trūkums simptomi pēcmenopauzes vecuma sievietēm ar dzemdes (ar vismaz 12 mēnešus kopš pēdējā menstruācija), par kuru ārstēšanu ar progestīnu saturošu terapija nav piemērota. pieredze, ārstējot sievietes vecākas par 65 gadiem, ir ierobežota.

Euroopan unioni - latvia - EMA (European Medicines Agency)

gedeon richter ltd  - ulipristāla acetāts - leiomioma - dzimumhormoni un dzimumsistēmas modulatori dzimumorgānu sistēma, - ulipristāla acetāts indicēts dzemdes fibroīdu vidēji smagiem vai smagiem simptomu preprogavai pieaugušo sievietēm reproduktīvā vecumā. ulipristal acetāts ir norādīts neregulāra ārstēšanā vidēji smagu vai smagu simptomu dzemdes fibroīdi pieaugušo sievietēm reproduktīvajā.

Euroopan unioni - latvia - EMA (European Medicines Agency)

orion corporation - toremifene - krūts audzējs - endokrīnā terapija - hormonu atkarīga metastātiska krūts vēža ārstēšana pirmajā hormonā pacientiem pēc menopauzes. fareston nav ieteicams lietot pacientiem ar estrogēnu receptoru negatīviem audzējiem.

Euroopan unioni - latvia - EMA (European Medicines Agency)

warner chilcott uk ltd. - testosterons - seksuālās disfunkcijas, psiholoģiskā - dzimumhormoni un dzimumsistēmas modulatori dzimumorgānu sistēma, - intrinsa hypoactive seksuālo vēlmi traucējumi (hsdd) ārstēšanai tiek norādīta abpusēji oophorectomised un hysterectomised (ķirurģiski izraisītas menopauzes) sievietes saņem vienlaicīga estrogēnu terapiju.

Euroopan unioni - latvia - EMA (European Medicines Agency)

hra pharma rare diseases - ketokonazols - cushing sindroms - antimycotics sistēmiskai lietošanai - ketokonazola hra indicēts endogēna kušinga sindroma ārstēšanai pieaugušajiem un pusaudžiem vecumā virs 12 gadiem.

Euroopan unioni - latvia - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumabs - 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 - antineoplastiski līdzekļi - 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. pacientiem ar egfr vai bĀziskĀ pozitīvas mutācijas audzēja arī būtu saņēmuši mērķtiecīgu terapiju, pirms saņem 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.

Euroopan unioni - latvia - EMA (European Medicines Agency)

eisai gmbh - lenvatinib mesilate - vairogdziedzera audzēji - antineoplastiski līdzekļi - lenvima ir norādīts kā monotherapy ārstēšanai pieaugušiem pacientiem ar progressive, uz vietas papildu vai metastātiska, diferencētas (papillārā/folikulu/hürthle šūnu) vairogdziedzera karcinoma (dtc), ugunsizturīgo radioaktīvo jodu (rai). lenvima ir norādīts kā monotherapy ārstēšanai pieaugušiem pacientiem ar progresējošu vai unresectable hepatocellular karcinomas (hcc), kas nav saņēmušas pirms sistēmiskā terapija.

Euroopan unioni - latvia - EMA (European Medicines Agency)

warner chilcott  deutschland gmbh - testosterons - seksuālās disfunkcijas, psiholoģiskā - dzimumhormoni un dzimumsistēmas modulatori dzimumorgānu sistēma, - livensa hypoactive seksuālo vēlmi traucējumi (hsdd) ārstēšanai tiek norādīta abpusēji oophorectomised un hysterectomised (ķirurģiski izraisītas menopauzes) sievietes saņem vienlaicīga estrogēnu terapiju.