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

advanced bionics australia pty ltd - 47374 - cochlear implant system sound processor - the sound processor is a miniature computer that converts sound picked up by the microphone into electrical signals that are used by the cochlear implant to enable hearing. the sound processor includes an on/off button and diagnostic indicators such as light emitting diodes and audible alarms. the processor can be programmed using intellilink to prevent use by a cochlear implant other than the one for which it has been programmed. it is designed to be worn on the body. the na?da ci is a behind-the-ear (bte) sound processor that converts sound picked up by the microphone into electrical signals that are used by the cochlear implant to enable hearing.

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

advanced bionics australia pty ltd - 60211 - hearing aid fitting/programming application software - soundwave professional suite software is used to create a patients sound processing strategy following implantation of the cochlear implant. the healthcare professional uses the software to modify various programmable parameters which are then downloaded to the sound processor soundwave professional suite software is used by a healthcare professional to program advanced bionics sound processors for use with advanced bionics cochlear implants.

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

medtronic australasia pty ltd -

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

biotronik australia pty ltd - 38141 - cardiac output unit, software - the software is for use with the biotronik renamic. the testing parameters include threshold; sensing (p/r measurement); retrograde conduction; intracardiac electrogram (iegm); ecg; and non-invasive programmed stimulation (nips). the programmer software is used during implantation and follow-up procedures on biotronik pacemakers, cardiac monitors and icds to carry out intraoperative tests; interrogate and program biotronik implantable cardiac monitors, pacemakers and icds.

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

hovid berhad - levetiracetam -

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

samsung bioepis co., ltd. - adalimumab (unii: fys6t7f842) (adalimumab - unii:fys6t7f842) - imraldi is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. imraldi can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (dmards). imraldi is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients from 4 to 17 years of age and ≥ 30 kg (66 lbs). imraldi can be used alone or in combination with methotrexate. imraldi is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. imraldi can be used alone or in combination with non-biologic dmards. imraldi is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. imraldi is indicated for reduci

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

sanofi pasteur - influenza a virus subtype h1n1 haemagglutinin, recombinant, influenza a virus subtype h3n2 haemagglutinin, recombinant, influenza b virus victoria lineage haemagglutinin, recombinant, influenza b virus yamagata lineage haemagglutinin, recombinant - influenza, human - vaccines - supemtek is indicated for active immunization for the prevention of influenza disease in adults.supemtek should be used in accordance with official recommendations.

Singapura - Inggeris - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - (amino acid solution) calcium chloride dihydrate corresp. to calcium chloride 0.56g; (amino acid solution) glycine (aminoacetic acid); (amino acid solution) l- histidine; (amino acid solution) l- isoleucine; (amino acid solution) l- leucine; (amino acid solution) l- methionine; (amino acid solution) l- serine; (amino acid solution) l- threonine; (amino acid solution) l- valine; (amino acid solution) l-alanine; (amino acid solution) l-arginine; (amino acid solution) l-lysine acetate corresp. to l-lysine 6.6g - emulsion - 0.740g per 1000ml - (amino acid solution) calcium chloride dihydrate corresp. to calcium chloride 0.56g 0.740g per 1000ml; (amino acid solution) glycine (aminoacetic acid) 11.0g per 1000ml; (amino acid solution) l- histidine 3.0g per 1000ml; (amino acid solution) l- isoleucine 5.0g per 1000ml; (amino acid solution) l- leucine 7.4g per 1000ml; (amino acid solution) l- methionine 4.3g per 1000ml; (amino acid solution) l- serine 6.5g per 1000ml; (amino acid solution) l- threonine 4.4g per 1000ml; (amino acid solution) l- valine 6.2g per 1000ml; (amino acid solution) l-alanine 14.0g per 1000ml; (amino acid solution) l-arginine 12.0g per 1000ml; (amino acid solution) l-lysine acetate corresp. to l-lysine 6.6g 9.3g per 1000ml; (amino acid solution) l-phenylalanine 5.1g per 1000ml; (amino acid solution) l-proline 11.2g per 1000ml; (amino acid solution) l-tryptophan 2.0g per 1000ml; (amino acid solution) l-tyrosine 0.40g per 1000ml; (amino acid solution) magnesium sulphate heptahydrate corresp. to magnesium sulphate 1.2g 2.47g per 1000m

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

advanced bionics australia pty ltd - 47374 - cochlear implant system sound processor - the na?da ci m90 is comprised of the following components: multi-function button, headpiece cable connector, light emitting diode, microphone ports, and battery connector. it features direct connectivity to wireless accessories and bluetooth? technology enabled devices. the na?da ci m90 offers multiple power options and wearing options for the user. the na?da ci m90 sound processor is an accessory of an auditory active implantable system, the hiresolution bionic ear system. the hiresolution bionic ear system is intended to provide auditory sensation via electrical stimulation of the auditory nerve for individuals with severe to profound bilateral or unilateral sensorineural hearing loss. severe hearing loss is defined as audiometric thresholds greater than or equal to 70 db hl, but less than 90 db hl. profound hearing loss is defined as audiometric thresholds greater than or equal to 90 db hl. the na?da ci m90 sound processor is a behind the ear (bte) sound processor which works together with the implant to bypass the damaged part of the inner ear and converts sound picked up by the microphone or streamed via wireless communication into electrical signals that are used by the cochlear implant to enable hearing. the na?da ci m90 is the premium version with full access to multiple automatic programs and features, including bimodal and bilateral and supports compatibility with acoustic amplification.

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

advanced bionics australia pty ltd - 58184 - cochlear implant system coil - the slim hp is a headpiece with an integrated cable designed for use with a sound processor worn on the ear. the slim hp is available with cable lengths of 3.5 inches/9cm, 4.25 inches/11cm, and 5.5 inches/14cm. the slim hps contain a magnet well designed to accommodate the appropriate slim hp magnet with appropriate strength to ensure retention between the cochlear implant and the headpiece. the slim hp is part of the external components of an auditory active-implantable system, the hiresolution bionic ear system. the slim hp is a headpiece with an integrated cable designed for use with a sound processor on the ear and is intended to transfer sound signals and power between advanced bionics? cochlear implant and sound processor.