Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer europe ma eeig - lorlatinib - karcinom, pljučni pljuč - antineoplastic agents, protein kinase inhibitors - lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)‑positive advanced non‑small cell lung cancer (nsclc) previously not treated with an alk inhibitor. lorviqua as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc whose disease has progressed after:alectinib or ceritinib as the first alk tyrosine kinase inhibitor (tki) therapy; orcrizotinib and at least one other alk tki.

Evropska unija - slovenščina - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastična sredstva - imatinib koanaa is indicated for the treatment ofadult 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. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe 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. bolniki, ki imajo nizko ali zelo nizko tveganje za ponovitev, ne bi smel imeti adjuvant treatment. 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. 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 gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. razen v novo diagnozo kronične faze cml, ni kontroliranih preskušanjih, dokazujejo kliničnih koristi ali poveča preživetje pri teh bolezni.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2); ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - suspenzija za injiciranje - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013 15 µg / 1 brizga  ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2)15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2) 15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021 15 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - cepivo proti gripi, z delci virusov ali s površinskimi antigeni, inaktivirano

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2); ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - suspenzija za injiciranje - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013 15 µg / 1 brizga  ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2)15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2) 15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021 15 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - cepivo proti gripi, z delci virusov ali s površinskimi antigeni, inaktivirano

Evropska unija - slovenščina - EMA (European Medicines Agency)

zoetis belgium sa - tulatromicin - antibakterij za sistemsko uporabo - pigs; cattle; sheep - govedo: zdravljenje in metaphylaxis goved, bolezni dihal (brd), ki je povezana z mannheimia haemolytica, pasteurella multocida, histophilus somni in mikroplazma bovis občutljivi na tulathromycin. prisotnost bolezni v čredi je treba določiti pred metafilaktičnim zdravljenjem. zdravljenje nalezljivih goveja keratoconjunctivitis (ibk), ki je povezana z moraxella bovis občutljivi na tulathromycin. prašiči: zdravljenje in metaphylaxis prašičje bolezni dihal (srd), ki je povezana z actinobacillus pleuropneumoniae, pasteurella multocida, mikroplazma hyopneumoniae, haemophilus parasuis in bordetella bronchiseptica, občutljivo za tulathromycin. prisotnost bolezni v čredi je treba določiti pred metafilaktičnim zdravljenjem. zdravilo draxxin je dovoljeno uporabljati samo, če se prašiči pričakujejo, da bodo bolezen razvili v 2-3 dneh. ovce: zdravljenje zgodnjih fazah nalezljivih pododermatitis (stopala gnilobe), ki je povezana s sovražno dichelobacter nodosus, ki zahteva sistemsko zdravljenje.

Evropska unija - slovenščina - EMA (European Medicines Agency)

ceva santé animale - florfenicol, meloxicam - amphenicols, kombinacije, antibacterials za sistemsko zdravljenje - govedo - za terapevtsko zdravljenje govedi, bolezni dihal (brd), ki je povezana z pyrexia zaradi mannheimia haemolytica, pasteurella multocida in histophilus somni dovzetni za florfenicol.

Evropska unija - slovenščina - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - drugi antineoplastiki - removab je indiciran za intraperitonealno zdravljenje malignih ascitesov pri bolnikih s pozitivnimi karcinomom epcam, pri katerih standardna terapija ni na voljo ali ni več izvedljiva.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

teva b.v. - everolimus - tableta - everolimus 2,5 mg / 1 tableta - everolimus

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

teva b.v. - everolimus - tableta - everolimus 10 mg / 1 tableta - everolimus

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

teva b.v. - everolimus - tableta - everolimus 5 mg / 1 tableta - everolimus