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

dominic saunders - 36149 - information system, blood bank administration - the cirdan ultra laboratory transfusion module was designed to support the blood bank technologist by tracking the testing of units and patients. the application can compare compatibility between patient(s) and unit based on patient abo/rh/ antibodies in comparison to the unit values for units that are to be dispensed to a patient. however, final decisions regarding compatibility and distribution of units are made by the blood bank technologist. the cirdan ultra laboratory transfusion module is intended to be used under the direct supervision of a licensed healthcare practitioner. due to the nature of the laboratory information device and the intended nature of its use and the professional environment in which they are intended, all users are fully trained on site with general instructions for use. the current status of this module is under class iia (ge healthcare certificate dv-20080327-mc-054479-11 ? laboratory ? class iia and gmdn 36149 designation: artg identifier: 152251) but following cirdan imaging submission to our notifying body bsi they have deemed the overall product in the eu to be self certifying including the transfusion module as it does not channel or store blood directly. the classification was previously confirmed as class iia by ge and gmed prior to the medical devices: guidance document 2.1/6

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

dominic saunders - 35477 - clinical laboratory information system - the medical device laboratory information system for the product cirdan ultra is a laboratory information system , classified mdd class i under rule 12 of annex ix of council directive 93/42/eec used in general pathology laboratories and in the blood transfusion bank for the use of professional personnel in the medical field. cirdan ultra laboratory is a robust laboratory information system (lis), uniquely designed to handle the high-volume test processing needs of mid- to large-sized labs.

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

advanz pharma - fluconazole - solution for infusion - 2mg/1ml

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

rb (health) malaysia sdn bhd - sodium alginate; potassium bicarbonate -

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

gedeon richter plc - lamotrigine - tablets - 100mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

gedeon richter plc - lamotrigine - tablets - 25mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

gedeon richter plc - lamotrigine - tablets - 50mg

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

bimeda, inc. - tulathromycin (unii: q839i13422) (tulathromycin - unii:q839i13422) - brd – macrosyn injectable solution is indicated for the treatment of bovine respiratory disease (brd) associated with mannheimia haemolytica , pasteurella multocida , histophilus somni , and mycoplasma bovis ; and for the control of respiratory disease in cattle at high risk of developing brd associated with mannheimia haemolytica , pasteurella multocida , histophilus somni , and mycoplasma bovis . ibk – macrosyn injectable solution is indicated for the treatment of infectious bovine keratoconjunctivitis (ibk) associated with moraxella bovis . foot rot – macrosyn injectable solution is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with fusobacterium necrophorum and porphyromonas levii . brd – macrosyn injectable solution is indicated for the treatment of brd associated with m. haemolytica , p. multocida , h. somni , and m. bovis . macrosyn injectable solution is indicated for the treatment of swine respiratory disease (srd) associated with actinobacillus pleurop

Malta - English - Medicines Authority

cis bio international route nationale 306-saclay, bp 32, 91192, gif-sur-yvette cedex, france - macrosalb - kit for radiopharmaceutical preparation - macrosalb 2 mg - diagnostic radiopharmaceuticals

Ireland - English - HPRA (Health Products Regulatory Authority)

seacross pharma (europe) limited - pemetrexed - powder for concentrate for solution for infusion - 100 milligram(s) - folic acid analogues; pemetrexed