United States - English - NLM (National Library of Medicine)

genzyme corporation - caplacizumab (unii: 2r27ab6766) (caplacizumab - unii:2r27ab6766) - cablivi is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (attp), in combination with plasma exchange and immunosuppressive therapy. cablivi is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of the excipients. hypersensitivity reactions have included urticaria [see adverse reactions (6.1)] . risk summary there are no available data on cablivi use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. however, there are potential risks of hemorrhage in the mother and fetus associated with use of cablivi (see clinical considerations) . in animal reproduction studies, there was no evidence of adverse developmental outcomes with intramuscular administration of caplacizumab-yhdp during organogenesis in guinea pigs at exposures approximately 30 times the auc in humans at the recommended subcutaneous injection dose of 11 mg (see data) . all pregnancies have a background ri

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

sanofi-aventis australia pty ltd - caplacizumab, quantity: 10 mg - injection, powder for - excipient ingredients: - cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (attp), in conjunction with plasma exchange and immunosuppression.

Israel - English - Ministry of Health

sanofi israel ltd - caplacizumab - powder and solvent for solution for injection - caplacizumab 10 mg/vial - caplacizumab - cablivi is indicated for the treatment of adults and adolescents of 12 years of age and older weighing at least 40 kg experiencing an episode of acquired thrombotic thrombocytopenic purpura (attp), in conjunction with plasma exchange and immunosuppression.

European Union - English - EMA (European Medicines Agency)

ablynx nv - caplacizumab - purpura, thrombotic thrombocytopenic - antithrombotic agents - cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (attp), in conjunction with plasma exchange and immunosuppression.

Canada - English - Health Canada

sanofi-aventis canada inc - caplacizumab - kit - 11mg - caplacizumab 11mg - antithrombotic agents, misc.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

ablynx nv, belgium - caplacizumab - powder and solvent for solution for injection - 10 mg

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

sanofi-aventis australia pty ltd - 45156 - medicine administration kit, percutaneous, medicated, single-use - cablivi (aust r 318058) is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (attp), in conjunction with plasma exchange and immunosuppression. each pack contains a caplacizumab powder vial and prefilled diluent syringe supplied together with a vial adapter, needle and swabs suitable for administration. packs of 1x or 7x all components.

Israel - English - Ministry of Health

kamada ltd, israel - bevacizumab - concentrate for solution for infusion - bevacizumab 25 mg/ml - bevacizumab - - bevacizumab kamada in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.- bevacizumab kamada 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. - bevacizumab kamada in combination with interferon alfa-2a is indicated for first line treatment of patients with advanced and /or metastatic renal cell cancer.- bevacizumab kamada in combination with paclitaxel is indicated for first-line treatment of patients with metastatic breast cancer.- bevacizumab kamada as a single agent, is indicated for the treatment of glioblastoma in patients with progressive disease following prior therapy.- bevacizumab kamada 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).- bevacizumab kamada 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.- bevacizumab kamada 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 - bevacizumab kamada 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 kamada 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.

United States - English - NLM (National Library of Medicine)

abbvie - daclizumab (unii: cuj2mvi71y) (daclizumab - unii:cuj2mvi71y) - daclizumab 150 mg in 1 ml - zinbryta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (ms). because of its safety profile, the use of zinbryta should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of ms. zinbryta is contraindicated in patients with: - pre-existing hepatic disease or hepatic impairment, including alt or ast at least 2 times the uln, because zinbryta could exacerbate existing liver dysfunction [see dosage and administration (2.3) and warnings and precautions (5.1)] . - a history of autoimmune hepatitis or other autoimmune condition involving the liver [see warnings and precautions (5.1)]. - a history of hypersensitivity to daclizumab or any other components of the formulation. use in such patients may result in anaphylaxis or life-threatening multi-organ hypersensitivity [see warnings and precautions (5.4)] . risk summary there are no adequate data on the developmental risk associated with use of zinbryta in

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

astrazeneca pty ltd - palivizumab, quantity: 100 mg - injection, solution - excipient ingredients: histidine; glycine; water for injections - synagis (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (rsv) in children at high risk of rsv disease. safety and efficacy were established in children with bronchopulmonary dysplasia (bpd), infants with a history of prematurity (gestational age less than or equal to 35 weeks at birth) and children with haemodynamically significant congenital heart disease (chd). (see clinical trials).