Unjoni Ewropea - Malti - EMA (European Medicines Agency)

gilead sciences ireland uc - idelalisib - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, other antineoplastic agents - zydelig is indicated in combination with an anti‑cd20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (cll):who have received at least one prior therapy, oras first line treatment in the presence of 17p deletion or tp53 mutation in patients who are not eligible for any other therapies. zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (fl) that is refractory to two prior lines of treatment.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - aġenti antineoplastiċi - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

nanotherapeutics bohumil, s.r.o. - whole virion influenza vaccine, inactivated containing antigen of strain a/california/07/2009 (h1n1)v - disease outbreaks; influenza, human; immunization - vaċċini - profilassi tal-influwenza kkawżata mill-virus a (h1n1) v 2009. celvapan ma għandu jintuża skont il-gwida uffiċjali.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pfizer europe ma eeig - lorlatinib - karċinoma, pulmun mhux taċ-Ċellula Żgħira - 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.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

astrazeneca ab - acalabrutinib - lewkimja, linfokitika, kronika, b-Ċellula - antineoplastic agents, protein kinase inhibitors, - calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll). calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll) who have received at least one prior therapy.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

roche registration gmbh - mosunetuzumab - limfoma, follicular - antineoplastic agents, monoclonal antibodies - lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (fl) who have received at least two prior systemic therapies.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

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. , l-effett ta ' imatinib fuq l-eżitu tal-trapjant tal-mudullun għadu ma ġiex determinat. 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. l-esperjenza b'imatinib f'pazjenti b'mds/mpd assoċjati ma ' tibdil fil-ġene pdgfr hija limitata ħafna. m'hemmx provi kliniċi li juru benefiċċju kliniku jew żieda fis-sopravivenza għal dawn il-mard.

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doxorubicin hydrochloride - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - aġenti antineoplastiċi - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Unjoni Ewropea - Malti - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. 1 of the smpc. aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. 1 of the smpc. aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics (figo) stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. 1 of the smpc). aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents. aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor targeted agents (see section 5. 1 of the smpc). aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5. 1 of the smpc).