Филипини - английски - FDA (Food And Drug Administration)

ambica international crop.; distributor: globo asiatico ent. inc. - bortezomib - powder for solution fo injection (iv/sc) - 3.5mg

Индия - английски - Central Drugs Standard Control Organization

panacea - inj. - 1 v.

САЩ - английски - NLM (National Library of Medicine)

antigen laboratories, inc. - chaetomium globosum (unii: 5016wb8b8a) (chaetomium globosum - unii:5016wb8b8a) - chaetomium globosum 0.05 g in 1 ml - allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. confirmation is determined by skin testing. diagnostic use of allergenic extracts usually begins with direct skin testing. this product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing. do not administer in the presence of diseases characterized by bleeding diathesis. individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying disease, possibly due to routine immunization. patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy. children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease.

Малайзия - английски - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

tabib wee hong - rhizoma arisaema erubescens; herba ardisia japonica; folium eriobotrya japonica.; flos tussilago farfara .; flos gomphrena globosa; radix platycodon grandiflorum; bulbus fritillaria cirrhosa -

Армения - английски - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

globopharm pharmazeutische produktions-und handels gmbh. - nonivamide, nicoboxil - ointment - 4mg/g+ 25mg/g

Сингапур - английски - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - agalsidase beta - injection, powder, for solution - 37.0mg/35mg vial - agalsidase beta 37.0mg/35mg vial

Сингапур - английски - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - agalsidase beta - injection, powder, for solution - 5.5mg/5mg vial - agalsidase beta 5.5mg/5mg vial

Австралия - английски - APVMA (Australian Pesticides and Veterinary Medicines Authority)

titan ag pty ltd - hexazinone - soluble concentrate - hexazinone triazine-triazinones active 250.0 g/l - herbicide

Европейски съюз - английски - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

САЩ - английски - NLM (National Library of Medicine)

amicus therapeutics us, llc - migalastat hydrochloride (unii: cly7m0xd20) (migalastat - unii:c4xny919fw) - galafold is indicated for the treatment of adults with a confirmed diagnosis of fabry disease and an amenable galactosidase alpha gene (gla ) variant based on in vitro assay data [see dosage and administration (2.1) and clinical pharmacology (12.1)] . this indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (kic gl-3) substrate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none. risk summary there were three pregnant women with fabry disease exposed to galafold in clinical trials. as such, the available data are not sufficient to assess drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed (see data) . the background risk for major birth defects and miscarriage for the indicated population is unk