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Biosimilaire
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15 documents available in our comprehensive collection of Biosimilaire resources. Find practical guides, tutorials, and documentation to enhance your knowledge.
Biosimilar Naming (yakusyokushinsahatu-0214-1.pdf)
118 KBEN 3 pages
バイオ後続品の一般的名称及び販売名は、バイオ後続品であることを明示するため、先行バイオ医薬品及びその他のバイオ後続品の名称とは容易に区別できるものとする。一般的名称は、先行バイオ医薬品の一般的名称の末尾に「後続1 (2,...
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761075s004lbl.pdf (761075s004lbl.pdf)
802 KBEN 20 pages
Fulphila (pegfilgrastim-jmdb) is a biosimilar to Neulasta (pegfilgrastim) used to decrease the incidence of infection, as manifested by febrile neutropenia, in...
Bekemv Approval (chmp-summary-positive-opinion-bekemv_en.pdf)
142 KBEN 2 pages
The CHMP adopted a positive opinion for Bekemv, a biosimilar medicinal product containing eculizumab, for the treatment of paroxysmal nocturnal haemoglobinuria...
Equivalenza Terapeutica (01_FrancescoSaverioMarini_Lequivalenza_terapeutica_tra_leggi_di_bilancio_e_diritto_costituzionale.pdf)
233 KBIT 12 pages
L'equivalenza terapeutica tra leggi di bilancio e diritto costituzionale riguarda il tema della sostituibilità dei farmaci biologici e biosimilari, con...
FDA Reauthorization Act (PLAW-115publ52.pdf)
425 KBEN 86 pages
The FDA Reauthorization Act of 2017 revises and extends user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological...
Drugs Used in Treatment for Dermatology and Gastroenterology Patients – FOI 395 (FOI-395.pdf)
310 KBEN 4 pages
Luton and Dunstable University Hospital and Bedford Hospital provided patient numbers treated with biologic drugs in the last 3 months.
Download image in PDF format (chmp-statistics-december-2017_en.pdf)
811 KBEN 1 page
December 2017
Positive opinions on extensions of therapeutic indications
Withdrawn applications
Total
New medicines: 6 (1 non-orphan, 2 orphan, 1...
Premsa Consejo (08/09/2014) (R2014098392.pdf)
49 KBES 2 pages
Una vacuna experimental contra el ébola ha demostrado su capacidad de prevenir la infección a largo plazo en primates, y la OMS espera tener 15.000 dosis de la...
Erelzi Overview (erelzi-epar-medicine-overview_hr.pdf)
108 KBEN 3 pages
Erelzi (etanercept) is an anti-inflammatory medicine used to treat immune system diseases, including rheumatoid arthritis, juvenile idiopathic arthritis,...
Prenesi (fv_32015.pdf)
2.05 MBEN 68 pages
The Pharmaceutical Journal of Slovenia, issue 3, 2015, focuses on the central theme of medicine prices and cost management.
Rebate Walls (RebateWall_F_web.pdf)
1.38 MBEN 43 pages
The current drug rebate system fails patients by increasing costs, with rebates growing at double-digit rates and patient costs skyrocketing.
Erelzi Overview (erelzi-epar-medicine-overview_sv.pdf)
108 KBEN 3 pages
Erelzi (etanercept) is an anti-inflammatory medicine used to treat immune system diseases, including rheumatoid arthritis, juvenile idiopathic arthritis,...
Tyruko, INN-natalizumab (tyruko-epar-medicine-overview_pl.pdf)
135 KBEN 3 pages
Tyruko (natalizumab) is an authorized EU medicine for treating highly active multiple sclerosis, a neurological condition where inflammation damages nerve sheaths. It's indicated for adults whose MS is not controlled by at least one other disease-modifying therapy.
EMA Approves Tyruko for Multiple Sclerosis Treatment (chmp-summary-positive-opinion-tyruko_en.pdf)
146 KBEN 2 pages
The European Medicines Agency (EMA) has recommended the approval of Tyruko (natalizumab) for treating multiple sclerosis, manufactured by Sandoz GmbH. Available as a 300mg concentrate for infusion, Tyruko exhibits selective immunosuppressive properties. For inquiries, visit...
（厚生労働省）令和４年度診療報酬改定 疑義解釈資料の送付について（その14） (000954941.pdf)
144 KBEN 3 pages
The Ministry of Health, Labour and Welfare's Insurance Bureau, Medical Affairs Division, has issued a notice regarding the interpretation of certain medical...
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