Europäische Union - Lettisch - EMA (European Medicines Agency)

baxalta innovations gmbh - imūbnglobulīns, normālais, cilvēka - imūndeficīta sindromi - un imūnglobulīni, - aizvietošanas terapija pieaugušajiem, bērniem un pusaudžiem (0 līdz 18 gadiem): primārā imūndeficīta sindromu ar ierobežotu antivielu ražošanas. hypogammaglobulinaemia un periodisko bakteriālas infekcijas pacientiem ar hronisku limfocītu leikēmija (cll), kuram, profilaktiskās antibiotikas nav vai tie nav norādīts. hypogammaglobulinaemia un periodisko bakteriālas infekcijas multiplā mieloma (mm) pacientiem. hypogammaglobulinaemia pacientiem pirms un pēc alogēnas asinsrades cilmes šūnu transplantācijas (hsct).

Europäische Union - Lettisch - EMA (European Medicines Agency)

intervet international bv - azagly-nafarelīns - hipofīzes un hipotalāma hormoni un analogi - dogs; salmonidae (salmonid fish) - sieviešu lašveidīgo zivju, piemēram, atlantijas laši (salmo salar), varavīksnes forele (oncorhynchus mykiss), taimiņš (salmo trutta) un palijas (salvelinus alpinus)indukcijas un sinhronizācija ovulācijas ražošanas acīm-olu un cep. suņi (kuces)novēršana gonādu funkciju kuces, izmantojot ilgtermiņa blokādi gonadotrophin sintēze.

Europäische Union - Lettisch - EMA (European Medicines Agency)

intervet international bv - estriol - dzimumorgānu dzimumhormoni un modulatori - suņi - no hormoniem atkarīgas urīna nesaturēšanas ārstēšana sfinktera mehānisma nekompetences dēļ olnīcu izraisītas ėermeĦveidīgām kucēm.

Europäische Union - Lettisch - EMA (European Medicines Agency)

novartis europharm limited - travoprost - ocular hypertension; glaucoma, open-angle - ophthalmologicals, antiglaucoma preparations and miotics - pacientiem ar acu hipertensiju vai atvērta leņķa glaukomu palielināts intraokulāro spiedienu pazemināšanās (skatīt 5. apakšpunktu). samazinājums paaugstināts intraokulārais spiediens pediatrijas pacienti vecumā no 3 gadiem līdz 18 gadiem ar acu hipertensija vai bērnu glaukoma.

Europäische Union - Lettisch - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptāns - polikistiskā nieres, autosomu dominējošā - diurētiskie līdzekļi, - jinarc ir norādīts lēni cistu attīstības virzību un nieru mazspējas gadījumā autosomāli dominējošs polycystic nieru slimības (adpkd) pieaugušajiem ar cepĻu posms 1 līdz 3 ārstēšanas uzsākšanu ar pierādījumiem par strauji progresē slimību.

Europäische Union - Lettisch - 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.

Europäische Union - Lettisch - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapīds - hiperholesterolēmija - lipīdu modificējoši aģenti - lojuxta ir norādīts, kā papildinājumu low‑fat diētu un citām lipid‑lowering zālēm ar vai bez zemākā density lipoproteīdu (ldl) aferēzes pieaugušiem pacientiem ar ģimenisko homozygous hypercholesterolaemia (hofh). Ģenētisko apstiprinājumu hofh būtu jāiegūst, kad vien iespējams,. citas formas primāro hyperlipoproteinaemia un sekundārie cēloņi hypercholesterolaemia e. nephrotic sindroms, hipotireoze), ir jāizslēdz.

Europäische Union - Lettisch - 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.

Europäische Union - Lettisch - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - pramipeksola dihidrohlorīda monohidrāts - restless legs syndrome; parkinson disease - anti-parkinsona zāles - mirapeksīns ir indicēts idiopātiskas parkinsona slimības pazīmju un simptomu ārstēšanai atsevišķi (bez levodopas) vai kombinācijā ar levodopu i. slimības gaitā, caur nobeiguma posmā levodopa iedarbību pagaist vai kļūst par nekonsekventu un terapeitisko efektu svārstības notiek (beigu devu vai "on-off" svārstības). mirapexin ir norādīts simptomātiska ārstēšana vidēji smagas idiopātiska nemierīgs-kājiņas sindroms devas līdz 0. 54 mg, parastā (0. 75 mg sāls).

Europäische Union - Lettisch - EMA (European Medicines Agency)

galderma international - brimonidīna tartrāts - Ādas slimības - citi dermatoloģiski preparāti - mirvaso ir indicēts rosacea sejas erythema simptomātiskai ārstēšanai pieaugušiem pacientiem.