European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents - blitzima is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)blitzima is indicated for the treatment of previously untreated patients with stage iii-iv follicular lymphoma in combination with chemotherapy.blitzima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.blitzima monotherapy is indicated for treatment of patients with stage iii-iv follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.blitzima is indicated for the treatment of patients with cd20 positive diffuse large b cell non-hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.chronic lymphocytic leukaemia (cll)blitzima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory cll. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including blitzima or patients refractory to previous blitzima plus chemotherapy.

European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituximab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastic agents - rituzena is indicated in adults for the following indications:non-hodgkin’s lymphoma (nhl)rituzena is indicated for the treatment of previously untreated patients with stage iii iv follicular lymphoma in combination with chemotherapy.rituzena monotherapy is indicated for treatment of patients with stage iii iv follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.rituzena is indicated for the treatment of patients with cd20 positive diffuse large b cell non hodgkin’s lymphoma in combination with chop (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.chronic lymphocytic leukaemia (cll)rituzena in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory cll. only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituzenaor patients refractory to previous rituzena plus chemotherapy.granulomatosis with polyangiitis and microscopic polyangiitisrituzena, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (wegener’s) (gpa) and microscopic polyangiitis (mpa).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

healthcare pharma ltd - simvastatin - oral tablet - 80mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

healthcare pharma ltd - nitrazepam - oral tablet - 5mg

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancermetastatic breast cancerherzuma is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):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 mbc, not previously treated with trastuzumab.early breast cancerherzuma is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc):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 herzuma therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.herzuma 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 cancer herzuma in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.herzuma should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accurate and validated assay methods should be used.

Canada - English - Health Canada

curium canada inc - indium in 111 chloride - solution - 10mci - indium in 111 chloride 10mci - radioactive agents

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

ge healthcare australia pty ltd - tetrofosmin, quantity: 0.23 mg; stannous chloride dihydrate, quantity: 0.03 mg - injection, solution - excipient ingredients: sodium bicarbonate; sodium gluconate; disodium sulfosalicylate - myoview is indicated as an adjunct in the diagnosis of ischaemic heart disease infarction.

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

ge healthcare australia pty ltd - indium (111in) chloride, quantity: 370 mbq/ml - injection, solution - excipient ingredients: hydrochloric acid - for the radiolabelling of approved polyaminocarboxylic acid derivatised monoclonal antibody preparations for in vivo diagnostic imaging procedures.

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

ge healthcare australia pty ltd - indium (111in) chloride, quantity: 370 mbq/ml - injection, solution - excipient ingredients: hydrochloric acid - for the radiolabelling of approved polyaminocarboxylic acid derivatised monoclonal antibody preparations for in vivo diagnostic imaging procedures.