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The HDM SLIT-tablet is marketed in Europe and Australia under the brand name ACARIZAX ® and in Japan as MITICURE TM The BLA for the HDM SLIT-tablet was originally submitted by MSD (known as Merck in the USA and Canada) in February 2016 under a partnership agreement with ALK --- pharmaceutical-technology com newsalks-hdm-tablet-acarizax-gets-appro Forsigtighedsregler Første dosis bør administreres under lægeopsyn med efterfølgende observation i mindst 30 min Akutberedskab omfatter adrenalin Evt reduktion af øvrig igangværende astmabehandling skal ske gradvist Astma skal stabiliseres før og under behandling, og behandlingsstart udskydes til mindst 3 måneder efter en svær ir alk net alk-announces-fda-approval-its-house-dust-mite-sublingualInitially, when Acarizax gained European approval for use in adults in 2015, it also became the first SLIT product to be approved for use in allergic asthma At present, the drug is approved in 17 countries worldwide and launched in nine countries --- ema europa eu p01602021-ema-decision-16-april-2021-acceptance-modific The safety and efficacy of ACARIZAX in children --- medicines org uk emc product 12905 smpcEuropean Medicines Agency decision EMA 190398 2021 Page 2 3 European Medicines Agency decision P 0160 2021 of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dermatophagoides pteronyssinus dermatophagoides farinae (Acarizax and associated names), (EMEA-001258-PIP01-11-Gravide og medicin Temaer Acarizax anvendes til allergivaccination mod allergi over for husstøvmider ved mindst en af flg tilstande: Voksne og børn over 12 år med moderat til svær allergisk rhinitis (hævet og betændt næseslimhinde), som er udløst af husstøvmider, og som ikke bliver bedre med symptomlindrende behandling P 0297 2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dermatophagoides pteronyssinus dermatophagoides farinae (Acarizax and associated names) Adopted First published: 13 09 2023 Last updated: 13 09 2023 Reference Number: P 0297 2022 English (EN) (226 74 KB - PDF) View --- pharmatimes com eu_expands_approval_of_alks_house_dust_mite_pill_1191444min medicin dk Medicin Praeparater 7925pro medicin dk Medicin Praeparater 7925--- globenewswire com ALK-s-European-registration-application-for-house-d ir alk-abello com new-product-product-acarizaxr-treatment-house-dust-mite --- ema europa eu en medicines human emea-001258-pip01-11-m08European regulators have expanded the scope of ALK-Abello’s Acarizax to include the treatment of adolescent patients with house dust mite-induced allergic rhinitis House dust mites are the most common cause of allergy in the world, affecting 90 million people in Europe, North America and Japan, and more than 100 million in China The ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “I’m pleased that our registration application for ACARIZAX ® for young children has been accepted for ACARIZAX ® is the first ever sublingual allergy immunotherapy tablet against house dust mite allergic rhinitis and allergic asthma to be approved in Europe The development activities have involved approximately 6,000 patients worldwide and this makes ACARIZAX ® the best documented product in the history of allergy immunotherapy
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