Uniunea Europeană - engleză - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - breast neoplasms - antineoplastic agents - piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative, locally advanced or metastatic breast cancer with a pik3ca mutation after disease progression following endocrine therapy as monotherapy (see section 5.1).

Australia - engleză - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - fulvestrant, quantity: 250 mg - injection, solution - excipient ingredients: benzyl alcohol; castor oil; benzyl benzoate; ethanol - fulvestrant accord is indicated for the treatment of postmenopausal women with: ? hormone-receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy. ? hr positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.

Uniunea Europeană - engleză - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - antineoplastic agents - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Australia - engleză - Department of Health (Therapeutic Goods Administration)

interpharma pty ltd - fulvestrant, quantity: 50 mg/ml - injection, solution - excipient ingredients: benzyl alcohol; benzyl benzoate; castor oil; ethanol - fulvestrant ever pharma is indicated for the treatment of postmenopausal women with: ? hormone-receptor (hr) positive, human epidermal growth factor receptor 2(her2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy. ? hr positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.

Uniunea Europeană - engleză - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - carcinoma, non-small-cell lung - antineoplastic agents - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Uniunea Europeană - engleză - EMA (European Medicines Agency)

taiho pharma netherlands b.v. - futibatinib - cholangiocarcinoma - antineoplastic agents - lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Uniunea Europeană - engleză - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosuppressants - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx.- the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists.in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate.tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx.tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx.tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older.tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Israel - engleză - Ministry of Health

roche pharmaceuticals (israel) ltd - bevacizumab - concentrate for solution for infusion - bevacizumab 25 mg/ml - bevacizumab - bevacizumab - - avastin in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.- avastin in addition to platinum - based chemotherapy is indicated for first - line treatment of patients with unresectable advanced metastatic or recurrent non- small cell lung cancer other than predominantly squamous cell histology. - avastin in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and /or metastatic renal cell cancer. - avastin in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.- avastin as asingle agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.- avastin, in combination with carboplatin and paclitaxel, is indicated for the front-line treatment of advanced (figo stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are at high risk for recurrence (residual disease after debulking).- avastin, in combination with carboplatin and gemcitabine, is indicated for the 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.- avastin ( bevacizumab) in combination with paclitaxel, 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 - avastin ( bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for treatment of patients with persistent, recurrent, or metastatic carcinoma of the cervix.- bevacizumab, 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. - bevacizumab, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.

Israel - engleză - Ministry of Health

astra zeneca (israel) ltd - fulvestrant - solution for injection - fulvestrant 250 mg / 5 ml - fulvestrant - fulvestrant - monotherapy :faslodex is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant endocrine therapy; or disease progression on endocrine therapy.combination therapy with palbociclib: faslodex is indicated for the treatment of hr-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy

Israel - engleză - Ministry of Health

astra zeneca (israel) ltd - fulvestrant - solution for injection - fulvestrant 250 mg / 5 ml - fulvestrant - fulvestrant - monotherapy :faslodex is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant endocrine therapy; or disease progression on endocrine therapy.combination therapy with palbociclib: faslodex is indicated for the treatment of hr-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy