INOmax European Union - English - EMA (European Medicines Agency)

inomax

linde healthcare ab - nitric oxide - hypertension, pulmonary; respiratory insufficiency - other respiratory system products - inomax, in conjunction with ventilatory support and other appropriate active substances, is indicated:for the treatment of newborn infants ≥34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation;as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.

Rotarix European Union - English - EMA (European Medicines Agency)

rotarix

glaxosmithkline biologicals s.a. - human rotavirus, live attenuated - immunization; rotavirus infections - vaccines - rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection.the use of rotarix should be based on official recommendation.

CellCept 500mg powder for solution for infusion vials United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

cellcept 500mg powder for solution for infusion vials

roche products ltd - mycophenolate mofetil hydrochloride - powder for solution for infusion - 500mg

Trazimera European Union - English - EMA (European Medicines Agency)

trazimera

pfizer europe ma eeig - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancermetastatic breast cancertrazimera 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 cancertrazimera 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 trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.trazimera 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 cancertrazimera 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-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.trazimera 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.

Dynastat European Union - English - EMA (European Medicines Agency)

dynastat

pfizer europe ma eeig - parecoxib sodium - pain, postoperative - coxibs, antiinflammatory and antirheumatic products - for the short-term treatment of postoperative pain in adults.,

Eperzan European Union - English - EMA (European Medicines Agency)

eperzan

glaxosmithkline trading services limited - albiglutide - diabetes mellitus, type 2 - drugs used in diabetes - eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as:monotherapywhen diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance.add-on combination therapyin combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).