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{"sheet":"Extensions","index":0,"n_rows":35,"n_cols":10,"rows_kept":35,"cut":false,"hidden":false,"merged":[[26,9,27,9],[28,9,29,9]]}
["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)"]
["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","2022-12-01",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"]
["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","Summary of Opinion","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"]
["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","2023-03-01",null,"Depottabletter 25 mg\nDepottabletter 50 mg"]
["Acalabrutinib","Calquence","AstraZeneca","L01EL02","EMEA/H/C/005299/X/0009/G","Ny dispenseringsform","Film-coated tablet","2023-03-01",null,"Hårde kapsler 100 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 ","2023-03-01",null,"Pulver til injektionsvæske, opl. 20 mg"]
["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"]
["Oritavancin","Tenkasi","Menarini International","J01X05","EMEA/H/C/003785/X/0036","Ny styrke","Powder for concentrate for solution for infusion; 1200 mg; infusion","2023-07-01",null,"Er ikke markedsført i Danmark"]
["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","2023-08-01",null,"Er ikke markedsført i Danmark"]
["Omalizumab","Xoliar","Novartis","R03DX05","EMEA/H/C/000606/X/0115/G","Ny styrke","Solution for injection; 300 mg (150 mg/ml)","2023-09-01",null,"Injektionsvæske, opl. 75 mg\n\tInjektionsvæske, opl. 150 mg"]
["Sildenafil","Viagra","Upjohn","G04BE03","EMEA/H/C/000202/X/0115","Ny dispenseringsform","Orodispersible film; po","2023-11-13",null,"Filmovertrukne tabletter 50 mg\nFilmovertrukne tabletter 100 mg"]
["Nintedanib","Ofev","Boehringer Ingelheim","L01EX09","EMEA/H/C/003821/X/0052/G","Ny styrke","Soft capsule; 25 mg; po","2023-11-13",null,"Bløde kapsler 100 mg\nBløde kapsler 150 mg"]
["Baricitinib","Olumiant","Eli Lilly Nederland","L04AA37","EMEA/H/C/004085/X/0035/G","Ny styrke","Film-coated tablet; 1 mg","2023-11-13",null,"Filmovertrukne tabletter 2 mg\nFilmovertrukne tabletter 4 mg"]
["Turoctocog alfa pegol","Esperoct","Novo Nordisk A/S","B02BD02","EMEA/H/C/004883/X/0016","Ny styrke","Powder and solvent for solution for injection; 4000 IU and 5000 IU","2023-11-13",null,"Pulver og solvens til injektionsvæske, opl. 500 IE\nPulver og solvens til injektionsvæske, opl. 1000 IE\nPulver og solvens til injektionsvæske, opl. 1500 IE\nPulver og solvens til injektionsvæske, opl. 2000 IE\nPulver og solvens til injektionsvæske, opl. 3000 IE"]
[]
["*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. 28-11-2022"]
[]
[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. 16-12-2022"]

{"sheet":"Populationsudvidelser","index":1,"n_rows":41,"n_cols":9,"rows_kept":41,"cut":false,"hidden":false,"merged":[[32,7,33,8],[34,7,35,8],[37,7,37,8],[38,7,38,8]]}
["Ansøgninger om populationsudvidelser* i godkendelsesproces hos EMA"]
[]
["Lægemiddelstof","Produktnavn","Virksomhed","ATC-kode","EMA procedurenummer","Kort indikation","Supplerende information","Est. EU godkendelse","Summary of Opinion"]
["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)","2022-12-01","Summary of Opinion"]
["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","2022-12-01","Summary of Opinion"]
["Baloxavir marboxil","Xofluza","Roche","J05AX25","EMEA/H/C/004974/X/0008/G",null,"From 1 year and above","2023-01-01","Summary of Opinion"]
["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","2023-02-01"]
["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","2023-02-01"]
["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","2023-02-01"]
["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","2023-02-01"]
["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","2023-02-01"]
["Tadalafil","Adcirca","Eli Lilly Nederland","G04BE08","EMEA/H/C/001021/X/0035/G",null,"Paediatric use (from 6 months to 17 years)","2023-02-01"]
["Dolutegravir / abacavir / lamivudine","Triumeq","ViiV Healthcare","J05AR13","EMEA/H/C/002754/X/0101/G",null,"Children weighing at least 14 kg to less  than 25 kg and children weighing at least 25 kg for the already approved film -coated tablets for Triumeq","2023-02-01"]
["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","2023-03-01"]
["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","2023-03-01"]
["Lumacaftor / ivacaftor","Orkambi","Vertex Pharmaceuticals","R07AX30","EMEA/H/C/003954/X/0078/G",null,"Children aged 1 to less than 2 years old of age","2023-03-01"]
["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"]
["Sacubitril / valsartan","Neparvis","Novartis","C09DX04","EMEA/H/C/004343/X/0042/G",null,"Children and adolescents aged one year or older","2023-04-01"]
["Somapacitan","Sogroya","Novo Nordisk A/S","H01AC07","EMEA/H/C/005030/X/0006/G",null,"Children and adolescents ","2023-04-01"]
["Sacubitril / valsartan","Entresto","Novartis","C09DX04","EMEA/H/C/004062/X/0044/G",null,"Children and adolescents aged one year or older","2023-04-01"]
["Ipilimumab","Yervoy","Bristol-Myers Squibb ","L01FX04","EMEA/H/C/002213/II/0100",null,"Adolescents (12 years of age and older); Nivolumab","2023-05-10"]
["Oritavancin","Tenkasi","Menarini International","J01X05","EMEA/H/C/003785/II/0037",null,"Paediatric population, aged between 3 months and less than 18 years","2023-05-10"]
["Semaglutide","Wegovy","Novo Nordisk A/S","A10BJ06","EMEA/H/C/005422/II/0009",null,"Adolescents","2023-05-10"]
["Nivolumab","Opdivo","Bristol-Myers Squibb ","L01FF01","EMEA/H/C/003985/II/0125/G",null,"Adolescent patients aged 12 years and older ; Ipilimumab","2023-05-10"]
["Concentrate of proteolytic enzymes enriched in bromelain","NexoBrid","MediWound Germany","D03BA03","EMEA/H/C/002246/II/0058",null,"Paediatric population","2023-05-10"]
["Baricitinib","Olumiant","Eli Lilly Nederland","L04AA37","EMEA/H/C/004085/X/0035/G",null,"Patients 2 years of age and older","2023-05-10"]
["Nintedanib","Ofev","Boehringer Ingelheim","L01EX09","EMEA/H/C/003821/X/0052/G",null,"Children and adolescents from 6 to 17 years of age","2023-05-10"]
["Riociguat","Adempas","Bayer AG","C02KX05","EMEA/H/C/002737/II/0037",null,"Paediatric patients aged 6 to less than 18 years of age; endothelin receptor antagonists with or without prostanoids","2023-05-10"]
["Agomelatine","Valdoxan","Les Laboratoires Servier","N06AX22","EMEA/H/C/000915/II/0051",null,"Adolescents aged 12 to 17 years","2023-06-10"]
[]
["*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. 28-11-2022"]
[]
[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. 16-12-2022"]