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

shs international ltd - powder

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

shs international ltd - powder

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

nutricia ltd - powder

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - taliglucerase alfa - powder for solution for infusion - taliglucerase alfa 200 u/vial - taliglucerase alfa - taliglucerase alfa - elelyso™ (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ert) for adults and pediatric patients with a confirmed diagnosis of type 1 gaucher disease

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

boehringer ingelheim pty ltd - tenecteplase, quantity: 50 mg - injection, powder for - excipient ingredients: arginine; phosphoric acid; polysorbate 20 - metalyse is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (ami). treatment should be initiated as soon as possible after the onset of symptoms. treatment can be initiated within 12 hours of symptom onset.

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

boehringer ingelheim pty ltd - tenecteplase, quantity: 40 mg - injection, powder for - excipient ingredients: polysorbate 20; arginine; phosphoric acid - metalyse is indicated for the thrombolytic treatment of the acute phase of myocardial infarction (ami). treatment should be initiated as soon as possible after the onset of symptoms. treatment can be initiated within 12 hours of symptom onset.

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

pfizer australia pty ltd - taliglucerase alfa, quantity: 212 u - injection, powder for - excipient ingredients: mannitol; citric acid; sodium citrate dihydrate; polysorbate 80 - elelyso is indicated for long-term enzyme replacement therapy for adult and paediatric patients with a confirmed diagnosis of type 1 gaucher disease associated with at least one of the following: splenomegaly, hepatomegaly, anaemia, thrombocytopenia.

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

viiv healthcare company - maraviroc (unii: md6p741w8a) (maraviroc - unii:md6p741w8a) - maraviroc 25 mg - selzentry is indicated in combination with other antiretroviral agents for the treatment of only ccr5‑tropic human immunodeficiency virus type 1 (hiv‑1) infection in adult and pediatric patients weighing at least 2 kg. limitations of use selzentry is contraindicated in patients with severe renal impairment or esrd (creatinine clearance [crcl] less than 30 ml per minute) who are concomitantly taking potent cyp3a inhibitors or inducers [see warnings and precautions (5.3)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to selzentry during pregnancy. physicians are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary limited data on the use of selzentry during pregnancy from the apr and case reports are not sufficient to inform a drug-associated risk of birth defects and miscarriage. in animal reproduction studies, no evidence of adverse developmental outcomes was observed with

European Union - English - EMA (European Medicines Agency)

actavis group ptc ehf - reteplase - myocardial infarction - antithrombotic agents - rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent st elevation or recent left bundle branch block within 12 hours after the onset of acute-myocardial-infarction (ami) symptoms.

Israel - English - Ministry of Health

baxter healthcare distribution ltd., israel - arginine; calcium chloride dihydrate; glycine; histidine; isoleucine; l- alanine; leucine; lysine hydrochloride; magnesium chloride hexahydrate; methionine; phenylalanine; proline; serine; sodium (s) - lactate; sodium chloride; threonine; tryptophan; tyrosine; valine - solution for peritoneal dialysis - tyrosine 0.3 g/l; tryptophan 0.27 g/l; phenylalanine 0.57 g/l; threonine 0.646 g/l; serine 0.51 g/l; proline 0595 g/l; glycine 0.51 g/l; l- alanine 0.951 g/l; valine 1.393 g/l; methionine 0.85 g/l; isoleucine 0.85 g/l; leucine 1.02 g/l; histidine 0.714 g/l; arginine 1.071 g/l; sodium chloride 5.38 g/l; lysine hydrochloride 0.955 g/l; calcium chloride dihydrate 0.184 g/l; magnesium chloride hexahydrate 0.051 g/l; sodium (s) - lactate 4.480 g/l - combinations of electrolytes - combinations of electrolytes - nutritional supplement for malnourished renal failure patients (albumin concentration lower then 35 g/liter) being maintained on peritoneal dialysis.