Европейски съюз - латвийски - 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.

Европейски съюз - латвийски - EMA (European Medicines Agency)

merck sharp & dohme b.v. - aprepitants - vomiting; postoperative nausea and vomiting; cancer - pretvemšanas un antinauseants, - emend 40 mg cietās kapsulas tiek norādīts novēršanas pēcoperācijas slikta dūša un vemšana (ponv) pieaugušajiem. emend ir pieejama arī kā 80 mg un 125 mg cietās kapsulas, lai novērstu sliktu dūšu un vemšanu, kas saistītas ar augsti un vidēji emetogenic vēža ķīmijterapija pieaugušajiem un pusaudžiem no 12 gadu vecuma (skatīt atsevišķu zāļu apraksts). emend ir pieejama arī kā 165 mg cietās kapsulas, lai novērstu akūta un aizkavēta nelabums un vemšana, kas saistīta ar ļoti emetogenic cisplatin, pamatojoties vēža ķīmijterapija pieaugušajiem un novēršanu, slikta dūša un vemšana, kas saistīta ar mēreni emetogenic vēža ķīmijterapija pieaugušajiem. emend ir arī pieejama kā pulveris iekšķīgai apturēšanu, lai novērstu sliktu dūšu un vemšanu, kas saistītas ar augsti un vidēji emetogenic vēža ķīmijterapija bērniem, maziem bērniem un zīdaiņiem vecumā no 6 mēnešiem līdz mazāk nekā 12 gadus. emend 80 mg, 125 mg, 165 mg cietās kapsulas un emend pulveris iekšķīgai apturēšanu tiek sniegta kā daļa no terapijas kombinācija.

Европейски съюз - латвийски - EMA (European Medicines Agency)

immunomedics gmbh - sulesomabs - osteomyelitis; radionuclide imaging - diagnostikas līdzekļi - Šīs zāles ir paredzētas tikai diagnostikas vajadzībām. leukoscan ir norādīts diagnostikas attēlveidošanas, lai noteiktu atrašanās vietu un apjomu, infekcija/iekaisums kaulu pacientiem ar aizdomām par osteomielīts, tostarp pacientiem ar diabētiskās pēdas čūlas. leukoscan nav bijis nodarbināts, lai diagnosticētu osteomielīts pacientiem ar sirpjveida šūnu anēmija.

Европейски съюз - латвийски - EMA (European Medicines Agency)

navidea biopharmaceuticals europe ltd. - tilmanocept - radionuklīdu attēlveidošana - audzēju konstatēšana, diagnostikas radiofarmaceitiskiem preparātiem - Šīs zāles ir paredzētas tikai diagnostikas vajadzībām. radioaktīvi lymphoseek ir norādīts attēlveidošanas un intraoperative atklāšanas sentinel limfmezgli drenāžas primārā audzēja pieaugušo pacientiem ar krūts vēža, melanoma, vai lokalizētu plakanšūnu karcinomu no mutes dobuma. Ārējās attēlveidošanas un intraoperative novērtēšana var tikt veikta, izmantojot gamma noteikšanas ierīce.

Европейски съюз - латвийски - EMA (European Medicines Agency)

regeneron ireland designated activity company (dac) - cemiplimab - karcinoma, švamšā šūna - antineoplastiski līdzekļi - cutaneous squamous cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. basal cell carcinomalibtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (labcc or mbcc) who have progressed on or are intolerant to a hedgehog pathway inhibitor (hhi). non-small cell lung cancerlibtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 (in ≥ 50% tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. libtayo in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with nsclc expressing pd-l1 (in ≥ 1% of tumour cells), with no egfr, alk or ros1 aberrations, who have:locally advanced nsclc who are not candidates for definitive chemoradiation, ormetastatic nsclc. cervical cancerlibtayo as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

Европейски съюз - латвийски - EMA (European Medicines Agency)

tmc pharma services ltd. - gadofosveseta trinātrija saturs - magnētiskās rezonanses angiogrāfija - kontrasta multivide - Šīs zāles ir paredzētas tikai diagnostikas vajadzībām. ablavar ir norādīts kontrastu pastiprinātu magnētiskās rezonanses angiogrāfija (ce-mra) vizualizācija vēdera vai ekstremitāšu kuģu tikai pieaugušajiem, ar aizdomas vai ir zināms, asinsvadu slimības.

Европейски съюз - латвийски - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - paclitaxel - breast neoplasms; pancreatic neoplasms; carcinoma, non-small-cell lung - antineoplastiski līdzekļi - abraxane monotherapy ir norādīts metastātiska krūts vēža ārstēšanai pieaugušiem pacientiem, kuriem nav pirmās līnijas attieksmi pret metastātiska slimība, un kam standarta, anthracycline, kas satur terapija nav norādīts. abraxane kopā ar gemcitabine ir norādīts pirmās līnijas ārstēšanai pieaugušiem pacientiem ar metastātisku aizkuņģa dziedzera adenokarcinomu. abraxane kopā ar carboplatin ir norādīts pirmās līnijas ārstēšana nav maza šūnu plaušu vēzis pieaugušiem pacientiem, kuriem nav kandidātu uz potenciāli dziednieciska operācijas un/vai staru terapiju,.

Европейски съюз - латвийски - EMA (European Medicines Agency)

actavis group hf - telmisartan, hydrochlorothiazide - essential hypertension - agents acting on the renin-angiotensin system, angiotensin ii antagonists and diuretics - esenciālas hipertensijas ārstēšana. actelsar hct fiksētu devu kombinācija (40 mg telmisartan / 12. 5 mg hydrochlorothiazide) ir norādīts pieaugušajiem, kuru asinsspiedienu nevar pienācīgi kontrolēt uz telmisartan vien. actelsar hct fiksētu devu kombinācija (80 mg telmisartan / 12. 5 mg hydrochlorothiazide) ir norādīts pieaugušajiem, kuru asinsspiedienu nevar pienācīgi kontrolēt uz telmisartan vien. actelsar hct fiksētu devu kombinācija (80 mg telmisartan / 25 mg hydrochlorothiazide) ir norādīts pieaugušajiem, kuru asinsspiedienu nevar pienācīgi kontrolēt uz actelsar hct 80 mg / 12. 5 mg (80 mg telmisartan / 12. 5 mg hidrohlortiazīds) vai pieaugušajiem, kas iepriekš ir stabilizēti, lietojot telmisartānu un hidrohlortiazīdu atsevišķi.

Европейски съюз - латвийски - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - pioglitazona hidrohlorīds - cukura diabēts, 2. tips - cukura diabēts - pioglitazone ir norādīts attieksmi pret 2. tipa cukura diabēts:kā monotherapy:pacientiem (īpaši lieko svaru, pacientiem) nepietiekami kontrolēts ar diētu un vingrinājumiem, par kuriem metformīns ir nevietā, jo ir kontrindikācijas vai nepanesamību;kā dual dobuma terapija kombinācijā ar:metformīns, pacientiem (īpaši lieko svaru, pacientiem), kuriem nepietiek glycaemic kontroles neskatoties maksimālā pieļaujama devu monotherapy ar metformīnu;a sulfonilurīnvielas pamata, tikai pacientiem, kas liecina par neiecietību pret metformīnu vai kurām metformīns ir kontrindicēta, ar nepietiekamu glycaemic kontroles neskatoties maksimālā pieļaujama devu monotherapy ar sulfonilurīnvielas pamata;kā triple dobuma terapija kombinācijā ar:metformīns un sulfonilurīnvielas pamata, pacientiem (īpaši lieko svaru, pacientiem), kuriem nepietiek glycaemic kontroles neskatoties uz dual dobuma terapija. pioglitazone ir arī norādīts kombinācija ar insulīnu, jo 2. tipa cukura diabēta pacientiem ar nepietiekamu glycaemic kontroli uz insulīnu, kam metformīns ir nevietā, jo ir kontrindikācijas vai neiecietību.

Европейски съюз - латвийски - EMA (European Medicines Agency)

ferrer internacional s.a. - loxapine - schizophrenia; bipolar disorder - nervu sistēma - adasuve ir norādīts ātri kontroles vieglas līdz vidēji satraukumu pieaugušiem pacientiem ar å ¡izofrä " nijas vai bipolāri traucējumi. pacienti regulāri jāārstē tūlīt pēc akūtas uzbudinājuma simptomu kontroles.