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.

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

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.

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

gulf drug llc belgium - 1 glass vial (powder) + 1 syringe (solvent) + 1 sterile vial adapter + 1 sterile needle + 2 alcohol swabs, - injection - 10 mg/vial - cardiovascular system-antiplatelet

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

Canada - English - Health Canada

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

Singapore - English - HSA (Health Sciences Authority)

welch allyn singapore pte. ltd. - cardiovascular - the welchallyn® connex® probp 3400™ automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates mean arterial pressure (map).

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

puma biotechnology, inc. - neratinib maleate (unii: 9rm7xy23zs) (neratinib - unii:jjh94r3pwb) - neratinib 40 mg - nerlynx as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (her2)-positive breast cancer, to follow adjuvant trastuzumab based therapy [see clinical studies ( 14.1)] . nerlynx in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic her2-positive breast cancer who have received two or more prior anti-her2 based regimens in the metastatic setting [see clinical studies ( 14.2)] . none. risk summary based on findings from animal studies and the mechanism of action, nerlynx can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1)] . there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of neratinib to pregnant rabbits during organogenesis resulted in abortions, embryo-fetal death and fetal abnormalities in rabbits at

European Union - English - EMA (European Medicines Agency)

pierre fabre medicament - neratinib - breast neoplasms - antineoplastic agents - nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive her2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.