Prevexxion RN Europese Unie - Letlands - EMA (European Medicines Agency)

prevexxion rn

boehringer ingelheim vetmedica gmbh - live recombinant marek’s disease (md) virus, serotype 1, strain rn1250 - imunoloģisks aves - cālis - for active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by marek’s disease (md) virus (including very virulent md virus).

Ultifend ND IBD Europese Unie - Letlands - EMA (European Medicines Agency)

ultifend nd ibd

ceva-phylaxia veterinary biologicals co. ltd - turkey herpes virus, strain rhvt/nd/ibd, expressing the fusion protein of newcastle disease virus and the vp2 protein of infectious bursal disease virus, live recombinant - imunoloģisks aves - embryonated chicken eggs; chicken - for the active immunisation of one-day-old chicks or 18-day-old chicken embryonated eggs to reduce mortality, clinical signs and lesions caused by newcastle disease virus (ndv) and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent infectious bursal disease virus (ibdv); to reduce mortality, clinical signs and lesions caused by classical marek’s disease virus (mdv).

Imatinib Accord Europese Unie - Letlands - EMA (European Medicines Agency)

imatinib accord

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and 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. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric 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-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. izņemot tikko diagnosticēta cml hroniskā fāzē, nav kontrolētos pētījumos, kas liecina par klīnisko ieguvumu vai palielina izdzīvošanas šo slimību. .

Imatinib Actavis Europese Unie - Letlands - 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.

Eravac Europese Unie - Letlands - EMA (European Medicines Agency)

eravac

laboratorios hipra, s.a. - inactivated rabbit haemorrhagic disease type 2 virus (rhdv2), strainv-1037 - inaktivētu vīrusu vakcīnām - truši - aktīvās imunizācijas truši, kas vecāki par 30 dienām, lai samazinātu mirstību, ko izraisa trušu hemorāģiskās slimības, 2. tipa vīruss (rhdv2).

Nobivac Myxo-RHD Europese Unie - Letlands - EMA (European Medicines Agency)

nobivac myxo-rhd

intervet international bv - dzīvot myxoma-vectored trušu hemorāģiskās slimības vīrusa celma 009 - imunoloģiskie līdzekļi - truši - lai aktīvi imunizētu trušus no piecu nedēļu vecuma, lai samazinātu miksomatozes mirstību un klīniskās pazīmes un novērstu mirstību no trušu hemorāģiskās slimības. imūnās iedarbības sākums: 3 nedēļas. imunitātes ilgums: 1 gads.

Kolbam Europese Unie - Letlands - EMA (European Medicines Agency)

kolbam

retrophin europe ltd - cholic acid - metabolisms, iedzimtās kļūdas - Žults un aknu terapija - cholic skābes fgk ir indicēts, lai ārstētu ar iedzimtu kļūdas par primāro žults skābju sintēzi, zīdaiņiem no viena mēneša vecuma nepārtraukti mūžizglītības ārstēšana ar pieaugušajiem, kas ietver šādus vienu fermentu defekti:stirols 27-hydroxylase (uzrādot kā cerebrotendinous xanthomatosis, ctx) trūkumi;2- (vai alfa-) methylacyl-coa racemase (amacr) trūkums;holesterīna 7 alfa-hydroxylase (cyp7a1) trūkumu.

Signifor Europese Unie - Letlands - EMA (European Medicines Agency)

signifor

recordati rare diseases - pasireotide - acromegaly; pituitary acth hypersecretion - hipofīzes un hipotalāma hormoni un analogi - signifor ir indicēts pieaugušiem pacientiem ar kušinga slimību, kuriem operācija nav risinājums vai kuriem operācija nav izdevies. signifor ir norādīts ārstēšanai pieaugušiem pacientiem ar akromegālijas operācijas, par kurām nav iespēju vai nav bijis dziedinošām un, kas ir nepietiekami kontrolē uz ārstēšanu ar citu somatostatin analogās.