{"text_format":"1","workbook":"xlsx","n_sheets":2,"sheets":["Extensions","Populationsudvidelser"],"not_rendered":{"charts":0,"images":1,"macros":1,"external_links":0,"defined_names":3,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

{"sheet":"Extensions","index":0,"n_rows":33,"n_cols":10,"rows_kept":33,"cut":false,"hidden":false,"merged":[[24,9,25,9],[26,9,27,9]]}
["Ansøgninger om Extensions* i godkendelsesproces hos EMA"]
[]
["Lægemiddelstof","Produktnavn","Virksomhed","ATC-kode","Procedurenr.","Extension type","Dispenseringsform; Styrke; Administrationsvej","Est. EU godkendelse","Summary of Opinion","Nuværende registreret dispenseringsform (Kilde: pro.medicin.dk)"]
["Mirabegron","Betmiga","Astellas Pharma Europe B.V.","G04BD12","EMEA/H/C/002388/X/0039/G","Ny styrke, ny dispenseringsform","Prolonged-release granules for oral suspension; 8 mg/ml; oral","2022-01-01",null,"Depottabletter 25 mg\nDepottabletter 50 mg"]
["Risankizumab","Skyrizi","AbbVie Deutschland","L04AC18","EMEA/H/C/004759/X/0020/G","Ny styrke, ny administrationsvej, ny dispenseringsform","Concentrate for solution for infusion; 600 mg; intravenous use\nSolution for injection; 360 mg (150 mg/ml); subcutaneous use","2022-12-01",null,"Injektionsvæske, opl. i pen 150 mg\nInjektionsvæske, opl. i sprøjte 75 mg\nInjektionsvæske, opl. i sprøjte 150 mg"]
["Bictegravir / emtricitabine / tenofovir alafenamide","Biktarvy","Gilead Sciences","J05AR20","EMEA/H/C/004449/X/0040/G","Ny styrke","(Film-coated tablets); 30/120/15 mg","2022-12-01",null,"Filmovertrukne tabletter 50/200/25 mg"]
["Acalabrutinib","Calquence","AstraZeneca","L01EL02","EMEA/H/C/005299/X/0009/G","Ny dispenseringsform","Film-coated tablet","2022-12-01",null,"Hårde kapsler 100 mg"]
["Baloxavir marboxil","Xofluza","Roche","J05AX25","EMEA/H/C/004974/X/0008/G","Ny styrke, ny dispenseringsform","Granules for oral suspension; 2 mg/ml; oral","2023-01-01",null,"Er udgået i maj 2022"]
["Tadalafil","Adcirca","Eli Lilly Nederland B.V","G04BE08","EMEA/H/C/001021/X/0035/G","Ny styrke, ny dispenseringsform","Oral suspension; 2 mg/ml; oral","2023-02-01",null,"Filmovertrukne tabletter 20 mg"]
["Dolutegravir / abacavir / lamivudine","Triumeq","ViiV Healthcare","J05AR13","EMEA/H/C/002754/X/0101/G","Ny dispenseringsform","Dispersible tablet; 5 mg/60 mg/30 mg; oral","2023-02-01",null,"Filmovertrukne tabletter 50+600+300 mg"]
["Remimazolam","Byfavo","PAION Netherlands B","N05CD14","EMEA/H/C/005246/X/0002","Ny styrke, ny dispenseringsform","Powder for concentrate for solution for injection/infusion; 50 mg; intravenous ","2023-02-01",null,"Pulver til injektionsvæske, opl. 20 mg"]
["Oritavancin","Tenkasi","Menarini International","J01X05","EMEA/H/C/003785/X/0036","Ny styrke","Powder for concentrate for solution for infusion; 1200 mg; infusion","2023-04-01",null,"Er ikke markedsført i Danmark"]
["Ravulizumab","Ultomiris","Alexion Europe","L04AA23","EMEA/H/C/004954/X/0027/G","Ny styrke, ny administrationsvej, ny dispenseringsform","Solution for injection; 245 mg; sc","2023-04-01",null,"Konc. til infusionsvæske, opl. 300mg/3 ml\nKonc. til infusionsvæske, opl. 1100mg/11 ml"]
["Nonacog beta pegol","Refixia","Novo Nordisk A/S","B02BD04","EMEA/H/C/004178/X/0027/G","Ny styrke","Powder and solvent for solution for injection; 3000 IU P; injection","2023-04-01",null,"Pulver og solvens til injektionsvæske, opl. 500 IU\nPulver og solvens til injektionsvæske, opl. 1 000 IU\nPulver og solvens til injektionsvæske, opl. 2 000 IU"]
["Elasomeran","Spikevax","Moderna Biotech","J07BX03","EMEA/H/C/005791/X/0065","Ny styrke","In pre-filled syringe; 0.10 mg/ml\nIn a 5-dose vial; 0.10 mg/ml","2023-06-01",null,"Injektionsvæske, dispersion"]
["Adalimumab","Hefiya","Sandoz GmbH","L04AB04","EMEA/H/C/004865/X/0036/G","Ny styrke","80 mg/0.8 ml; injection","2023-07-01",null,"Er ikke markedsført i Danmark"]
["Adalimumab","Hyrimoz","Sandoz GmbH","L04AB04","EMEA/H/C/004320/X/0036/G","Ny styrke","80 mg/0.8 ml; injection","2023-07-01",null,"Injektionsvæske, opl. i pen 40 mg\nInjektionsvæske, opl. i sprøjte 20 mg\nInjektionsvæske, opl. i sprøjte 40 mg"]
["Lumacaftor / ivacaftor","Orkambi","Vertex Pharmaceuticals","R07AX30","EMEA/H/C/003954/X/0078/G","Ny styrke","Granules; 75 mg of lumacaftor and 94 mg of ivacaftor fixed dose; Oral","2023-07-01",null,"Filmovertrukne tabletter 200 mg/125 mg (kan dosisdisp.)\nFilmovertrukne tabletter 100 mg/125 mg (kan dosisdisp.)\nGranulat i brev 100 mg+125 mg\nGranulat i brev 150 mg+188 mg"]
["Somapacitan","Sogroya","Novo Nordisk A/S","H01AC07","EMEA/H/C/005030/X/0006/G","Ny styrke","Solution for injection in pre-filled pen; 15 mg/1.5 mL solution; SC","2023-08-01",null,"Injektionsvæske, opl. i pen; 10 mg/1,5 ml"]
["Sacubitril / valsartan","Entresto","Novartis","C09DX04","EMEA/H/C/004062/X/0044/G","Ny dispenseringsform","Granules in capsule for opening; 6 mg/6 mg and 15 mg/16 mg ; Oral","2023-08-01",null,"Filmovertrukne tabletter 24 mg + 26 mg\nFilmovertrukne tabletter 97 mg + 103 mg\nFilmovertrukne tabletter 49 mg + 51 mg"]
["Sacubitril / valsartan","Neparvis","Novartis","C09DX04","EMEA/H/C/004343/X/0042/G","Ny styrke","Granules in capsule for opening; 6 mg/6 mg granules in capsule for opening and 15 mg/16 mg granules in capsule for opening; Oral","ug 23",null,"Er ikke markedsført i Danmark"]
[]
["*Extensions: Ny styrke, ny dispenseringsform eller ny administrationsvej for et allerede registreret lægemiddel. ",null,null,null,null,null,null,null,null,"Baseret på tilgængelig EMA-data d. 25-08-2022"]
[]
[null,null,null,null,null,null,null,null,null,"Horizon Scanning"]
[]
[null,null,null,null,null,null,null,null,null,"Vi hører meget gerne fra dig, hvis du har spørgsmål til listen."]
[]
[]
[null,null,null,null,null,null,null,null,null,"Mail: horizonscanning@amgros.dk"]
[null,null,null,null,null,null,null,null,null,"Amgros tlf.: 88 71 30 00"]
[]
[null,null,null,null,null,null,null,null,null,"Udarbejdet af: Anna Bergkvist Christensen d. 15-09-2022"]

{"sheet":"Populationsudvidelser","index":1,"n_rows":31,"n_cols":9,"rows_kept":31,"cut":false,"hidden":false,"merged":[[22,7,23,8],[24,7,25,8],[27,7,27,8],[28,7,28,8]]}
["Ansøgninger om populationsudvidelser* i godkendelsesproces hos EMA"]
[]
["Lægemiddelstof","Produktnavn","Virksomhed","ATC-kode","EMA procedurenummer","Kort indikation","Supplerende information","Est. EU godkendelse","Summary of Opinion"]
["Elasomeran","Spikevax","Moderna Biotech","J07BX03","EMEA/H/C/005791/II/0067","Active immunization against COVID-19 disease","Paediatric individuals from 6 months through 5 years","2022-11-23"]
["Dalbavancin","Xydalba","Allergan Pharmaceuticals","J01XA04","EMEA/H/C/002840/II/0043","Treatment of ABSSSI, paediatric population (aged 3 months to < 18 years).","Paediatric population (aged 3 months to < 18 years)","2022-11-23"]
["Dupilumab","Dupixent","sanofi-aventis groupe","D11AH05","EMEA/H/C/004390/II/0060","Atopic dermatitis in paediatric patients from 6 months to <6 years of age","Paediatric patients from 6 months to <6 years of age","2022-11-23"]
["Bictegravir / emtricitabine / tenofovir alafenamide","Biktarvy","Gilead Sciences","J05AR20","EMEA/H/C/004449/X/0040/G","HIV","Use in patients 2 years of age and older and weighing at least 14 kg","2022-12-01"]
["Teduglutide","Revestive","Shire Pharmaceuticals","A16AX08","EMEA/H/C/002345/II/0054/G","Short bowel syndrom","Patients from 4 months corrected gestational aged 1 year and above","2022-12-01"]
["Bupivacaine","EXPAREL liposomal","Pacira Ireland Limited","N01BB01","EMEA/H/C/004586/II/0005","Post-operative pain","Children over 6 years old","2022-12-01"]
["Tenofovir alafenamide","Vemlidy","Gilead Sciences","J05AF13","EMEA/H/C/004169/II/0040","Treatment of chronic hepatitis B-infected children from 6 years and older and weighing at least 25 kilograms","Children from 6 years and older and weighing at least 25 kilograms","2023-01-23"]
["Epoetin beta","Mircera","Roche Registration GmbH","B03AX03","EMEA/H/C/000739/II/0092","Symptomatic anaemia associated with chronic kidney disease (CKD)","Paediatric patients from 3 months to less than 18 years of age","2023-01-23"]
["Pitolisant","Wakix","Bioprojet Pharma","N07XX11","EMEA/H/C/002616/II/0030","Narcolepsy with or without cataplexy","Adolescents and children from the age of 6 years","2023-01-23"]
["Human thrombin / human fibrinogen","TachoSil","Corza Medical GmbH","B02BC30","EMEA/H/C/000505/II/0117","Supportive treatment in surgery","Children aged 1 month to 18 years","2023-01-23"]
["Dulaglutide","Trulicity","Eli Lilly","A10BJ05","EMEA/H/C/002825/II/0065","Extension of indication to include treatment of type 2 diabetes mellitus (T2DM) in children and adolescents aged 10 to less than 18 years based on final results from study H9X-MC-GBGC","Adolescents aged 10 to less than 18 years","2023-02-21"]
["Recombinant vesicular stomatitis virus - Zaire ebolavirus vaccine (live)","Ervebo","Merck Sharp & Dohme B.V.","J07BX02","EMEA/H/C/004554/II/0025","Ebola Vaccine","Paediatric population from 1 year to less than 18 years","2023-03-16"]
["Tralokinumab","Adtralza","LEO Pharma ","D11AH07","EMEA/H/C/005255/II/0002","Moderate-to-severe atopic dermatitis","Adolescent patients 12 to 17 years of age","2023-03-25"]
["Pneumococcal polysaccharide conjugate vaccine (adsorbed)","Vaxneuvance","Merck Sharp & Dohme B.V.","J07AL02","EMEA/H/C/005477/II/0001","Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media","Children and adolescents from 6 weeks to less than 18 years of age","2023-03-25"]
["Insulin lispro","Lyumjev","Eli Lilly Nederland B.V.","A10AB04","EMEA/H/C/005037/II/0014","Diabetes mellitus","Adolescents and children aged 1 year and above","2023-03-25"]
["Remdesivir","Veklury","Gilead Sciences","J05AB16","EMEA/H/C/005622/II/0035/G","Treatment of COVID-19","Paediatric patients","2023-03-25"]
[]
["*Populationsudvidelse: En ny patientgruppe føjes til indikationen. Eksempel: Daptomycin til pædiatriske patienter mellem 1 og 17 år",null,null,null,null,null,null,null,"Baseret på tilgængelig EMA-data d. 25-08-2022"]
[]
[null,null,null,null,null,null,null,"Horizon Scanning"]
[]
[null,null,null,null,null,null,null,"Vi hører meget gerne fra dig, hvis du har spørgsmål til listen."]
[]
[]
[null,null,null,null,null,null,null,"Mail: horizonscanning@amgros.dk"]
[null,null,null,null,null,null,null,"Amgros tlf.: 88 71 30 00"]
[]
[null,null,null,null,null,null,null,null,"Udarbejdet af: Anna Bergkvist Christensen d. 15-09-2022"]