European Union - English - EMA (European Medicines Agency)

roche registration ltd. - ibandronic acid - osteoporosis, postmenopausal - drugs for treatment of bone diseases - treatment of osteoporosis in post-menopausal women at increased risk of fracture.a reduction in the risk of vertebral fractures has been demonstrated. efficacy on femoral-neck fractures has not been established.

European Union - English - EMA (European Medicines Agency)

roche registration ltd. - nelfinavir - hiv infections - antivirals for systemic use - viracept is indicated in antiretroviral combination treatment of human-immunodeficiency-virus (hiv-1)-infected adults, adolescents and children of three years of age and older.in protease-inhibitor (pi)-experienced patients, the choice of nelfinavir should be based on individual viral resistance testing and treatment history.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - bevacizumab - carcinoma, non-small-cell lung; breast neoplasms; ovarian neoplasms; colorectal neoplasms; carcinoma, renal cell - antineoplastic agents - bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. for further information as to human epidermal growth factor receptor 2 (her2) status.bevacizumab 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 anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with avastin in combination with capecitabine. for further information as to her2 status.bevacizumab, 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.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 interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.bevacizumab, 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.bevacizumab, in combination with carboplatin and gemcitabine, 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.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.bevacizumab, 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.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - mycophenolate mofetil - graft rejection - immunosuppressants - cellcept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - cobimetinib hemifumarate - melanoma - antineoplastic agents - cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - vismodegib - carcinoma, basal cell - antineoplastic agents - erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunosuppressants - esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - enfuvirtide - hiv infections - antivirals for systemic use - fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of hiv-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.in deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. where available, resistance testing may be appropriate.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - obinutuzumab - leukemia, lymphocytic, chronic, b-cell - antineoplastic agents - chronic lymphocytic leukaemia (cll)gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1).follicular lymphoma (fl)gazyvaro in combination with chemotherapy, followed by gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.gazyvaro in combination with bendamustine followed by gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (fl) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancermetastatic breast cancerherceptin is indicated for the treatment of patients with her2-positive metastatic breast cancer:as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. hormone-receptor-positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments;in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable;in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease;in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive metastatic breast cancer, not previously treated with trastuzumab.early breast cancerherceptin is indicated for the treatment of patients with her2-positive early breast cancer:following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable);following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel;in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin;in combination with neoadjuvant chemotherapy followed by adjuvant herceptin therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter.herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.metastatic gastric cancerherceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with her2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anticancer treatment for their metastatic disease.herceptin should only be used in patients with metastatic gastric cancer whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc3+ result. accurate and validated assay methods should be used.