Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

zeria pharmaceutical co., ltd. - fidaxomicin - pale yellow red tablet, major axis: approx. 13.1 mm, minor axis: approx. 7.0 mm, thickness : approx. 5.1 mm

Malta - English - Medicines Authority

sanofi malta limited - amiodarone hydrochloride - solution for injection - amiodarone hydrochloride 150 milligram(s) - cardiac therapy

Malta - English - Medicines Authority

sanofi malta limited - amiodarone hydrochloride - tablet - amiodarone hydrochloride 200 milligram(s) - cardiac therapy

Malta - English - Medicines Authority

sanofi s.r.l viale l. bodio, 37/b 20158, milan, italy - amiodarone hydrochloride - solution for injection - amiodarone hydrochloride 50 mg/ml - cardiac therapy

Malta - English - Medicines Authority

sanofi s.r.l viale l. bodio, 37/b 20158, milan, italy - amiodarone hydrochloride - tablet - amiodarone hydrochloride 200 mg - cardiac therapy

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - amiodarone hydrochloride -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

sanofi-aventis (malaysia) sdn. bhd. - amiodarone hydrochloride -

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

merck sharp & dohme (australia) pty ltd - bezlotoxumab -

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - bezlotoxumab - enterocolitis, pseudomembranous - immune sera and immunoglobulins, - zinplava is indicated for the prevention of recurrence of clostridium difficile infection (cdi) in adults at high risk for recurrence of cdi.

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

merck sharp & dohme llc - bezlotoxumab (unii: 4h5ymk1h2e) (bezlotoxumab - unii:4h5ymk1h2e) - bezlotoxumab 25 mg in 1 ml - zinplava™ is indicated to reduce recurrence of clostridioides difficile infection (cdi) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for cdi and are at a high risk for cdi recurrence. limitation of use: zinplava is not indicated for the treatment of cdi. zinplava is not an antibacterial drug. zinplava should only be used in conjunction with antibacterial drug treatment of cdi. [see dosage and administration (2.1).] none. risk summary adequate and well controlled studies with zinplava have not been conducted in pregnant women. no animal reproductive and developmental studies have been conducted with bezlotoxumab. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. risk summary there is no information regarding the presence of bezlotoxumab in human m