Imatinib Actavis Europska Unija - latvijski - EMA (European Medicines Agency)

imatinib actavis

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. spēkā imatinib par rezultātiem, kaulu smadzeņu transplantācija nav noteikta. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. pieredze ar imatinib pacientiem ar mds/mpd, kas saistīti ar pdgfr gēnu re-kārtība ir ļoti ierobežota. nav kontrolētos pētījumos, kas liecina par klīnisko ieguvumu vai palielina izdzīvošanas šo slimību.

Kepivance Europska Unija - latvijski - EMA (European Medicines Agency)

kepivance

swedish orphan biovitrum ab (publ) - palifermin - mucosīts - visi pārējie terapeitiskie produkti - kepivance norādīja, lai samazinātu biežumu, ilgumu un smagumu mutvārdu mucositis pieaugušiem pacientiem ar hematoloģisko malignancies saņem myeloablative radiochemotherapy, kas saistītas ar augsta saslimstība ar nopietnu mucositis un prasa autologās-asinsrades-cilmes šūnu atbalsts.

Lonquex Europska Unija - latvijski - EMA (European Medicines Agency)

lonquex

teva b.v. - lipegfilgrastim - neitropēnija - imunitātes stimulatori, , koloniju stimulējošā faktori - lonquex is indicated in adults and in children 2 years of age and older for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Venclyxto Europska Unija - latvijski - EMA (European Medicines Agency)

venclyxto

abbvie deutschland gmbh co. kg - venetoklakss - leikēmija, limfocītu, hroniska, b-šūna - antineoplastiski līdzekļi - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Thalidomide BMS (previously Thalidomide Celgene) Europska Unija - latvijski - EMA (European Medicines Agency)

thalidomide bms (previously thalidomide celgene)

bristol-myers squibb pharma eeig - talidomīds - multiple mieloma - imūnsupresanti - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Palonosetron Accord Europska Unija - latvijski - EMA (European Medicines Agency)

palonosetron accord

accord healthcare s.l.u. - palonosetrons - vomiting; nausea; cancer - pretvemšanas un antinauseants, - palonosetron accord ir norādīts pieaugušajiem:novērst akūtas slikta dūša un vemšana, kas saistīta ar ļoti emetogenic vēža ķīmijterapija,profilakses, slikta dūša un vemšana, kas saistīta ar mēreni emetogenic vēža ķīmijterapija. palonosetron accord ir norādīts pediatrijas pacientiem no 1 mēneša vecuma un vecākiem:novērst akūtas slikta dūša un vemšana, kas saistīta ar ļoti emetogenic vēža ķīmijterapija un novēršanu, slikta dūša un vemšana, kas saistīta ar mēreni emetogenic vēža ķīmijterapija.

Teysuno Europska Unija - latvijski - EMA (European Medicines Agency)

teysuno

nordic group b.v. - ftorafūrs, gimeracil, oteracil - kuņģa-zarnu trakta traucējumi - antineoplastiski līdzekļi - teysuno is indicated in adults:- for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5. - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting.

Xtandi Europska Unija - latvijski - EMA (European Medicines Agency)

xtandi

astellas pharma europe b.v. - enzalutamide - prostatas audzēji - endokrīnā terapija - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Prevomax Europska Unija - latvijski - EMA (European Medicines Agency)

prevomax

dechra regulatory b.v. - maropitants - gremošanas traktam un metabolismam, citi pretvemšanas - cats; dogs - suņi:ārstēšanai un profilaksei, slikta dūša, izraisa chemotherapyfor novēršanu vemšana, izņemot gadījumus, kas izraisa kustību sicknessfor ārstēšanu, vemšana, kopā ar citiem atbalsta measuresfor novēršanu perioperatīvo slikta dūša un vemšana, kā arī uzlabot atgūšanos no vispārējās anestēzijas pēc lietošanas μ-opiātu receptoru agonists morphinecats:lai novērstu vemšanu un samazināšana, slikta dūša, izņemot to, ka izraisa kustības sicknessfor ārstēšanu, vemšana, kopā ar citu atbalsta pasākumu.

Bavencio Europska Unija - latvijski - EMA (European Medicines Agency)

bavencio

merck europe b.v. - avelumabs - neiroendokrīnas audzēji - citi antineoplastiskie līdzekļi pārstāvji, monoklonālo antivielu - bavencio ir indicēts kā monoterapija pieaugušiem pacientiem ar metastātisku merkēnu šūnu karcinomu (mcc). bavencio kopā ar axitinib ir norādīts pirmās līnijas ārstēšanai pieaugušiem pacientiem ar progresējošu nieru šūnu karcinomas (rsp). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.