{"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":37,"n_cols":10,"rows_kept":37,"cut":false,"hidden":false,"merged":[[28,9,29,9],[30,9,31,9]]}
["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)"]
["Paliperidone","Paliperidone Janssen-Cilag International","Janssen-Cilag International ","N05AX13","EMEA/H/C/005486/X/0002/G","Ny styrke","Prolonged-release suspension for injection; 700 mg and 1000 mg","2021-11-01","Summary of Opinion","Ikke markedsført i Danmark. "]
["Posaconazole","Noxafil","Merck Sharp & Dohme B.V.","J02AC04","EMEA/H/C/000610/X/0063/G","Ny dispenseringsform","Gastro-resistant powder and solvent for oral suspension","2021-12-01","Summary of Opinion","Enterotabletter; 100 mg\nOral suspension;. 1 ml indeholder 40 mg\nKoncentrat til infusionsvæske, opløsning; 1 ml indeholder 18 mg"]
["Sofosbuvir / velpatasvir","Epclusa","Gilead Sciences Ireland UC","J05AP55","EMEA/H/C/004210/X/0056/G","Ny dispenseringsform","Coated granules in sachet; 200 mg/50 mg and 150 mg/37.5 mg","2022-01-01","Summary of Opinion","Filmovertrukne tabletter 200+50 mg\nFilmovertrukne tabletter 400+100 mg"]
["Ivacaftor / tezacaftor / elexacaftor ","Kaftrio","Vertex Pharmaceuticals","R07AX32","EMEA/H/C/005269/X/0008/G","Ny styrke","Film-coated tablets;  37.5 mg/25 mg/50 mg ","2022-01-01","Summary of Opinion","Filmovertrukne tabletter; 75+50+100 mg"]
["Deferiprone","Ferriprox","Chiesi Farmaceutici S.p.A.","V03AC02","EMEA/H/C/000236/X/0145","Ny dispenseringsform","Gastro-resistant tablets","2022-02-01",null,"Filmovertrukne tabletter; 500 mg \nFilmovertrukne tabletter; 1.000 mg"]
["Semaglutide","Ozempic","Novo Nordisk","A10BJ06","EMEA/H/C/004174/X/0021","Ny styrke","Solution for injection; 2 mg","2022-02-01",null,"Injektionsvæske, opl. i pen; 0,25 mg\nInjektionsvæske, opl. i pen; 0,5 mg\nInjektionsvæske, opl. i pen; 1 mg"]
["Dupilumab","Dupixent","Sanofi-Aventis","D11AH05","EMEA/H/C/004390/X/0045/G","Ny styrke","Solution for injection; 100 mg/ml","2022-03-01",null,"Injektionsvæske, opl. i pen; 200 mg\nInjektionsvæske, opl. i pen; 300 mg\nInjektionsvæske, opl. i sprøjte; 200 mg\nInjektionsvæske, opl. i sprøjte; 300 mg"]
["Tofacitinib","Xeljanz","Pfizer Europe MA EEIG","L04AA29","EMEA/H/C/004214/X/0030/G","Ny styrke","Prolonged-release tablet; 22 mg ","2022-03-01",null,"Filmovertrukne tabletter; 5 mg\nFilmovertrukne tabletter; 10 mg\nDepottabletter; 11 mg"]
["Rurioctocog alfa pegol","Adynovi","Baxalta Innovations ","B02BD02","EMEA/H/C/004195/X/0018","Ny styrke","Powder and solvent for solution for injection, for intravenous use; 3000 IU ","2022-03-01",null,"Pulver og solvens til injektionsvæske; opl. 500 IU/2 ml\nPulver og solvens til injektionsvæske; opl. 1000 IU/2 ml\nPulver og solvens til injektionsvæske; opl. 2000 IU/5 ml"]
["Avapritinib","AYVAKYT","Blueprint Medicines (Netherlands) B.V.","L01EX18\t","EMEA/H/C/005208/X/0004/G","Ny styrke","Film- coated tablets; 25 mg and 50 mg","2022-03-01",null,"Filmovertrukne tabletter; 100 mg\nFilmovertrukne tabletter; 200 mg\nFilmovertrukne tabletter; 300 mg"]
["Simoctocog alfa","Nuwiq","Octapharma AB","B02BD02","EMEA/H/C/002813/X/0042","Ny styrke","Powder and solvent for solution for injection; 1500 IU","2022-03-01",null,"Pulver og solvens til injektionsvæske, opl; 250 IU\nPulver og solvens til injektionsvæske, opl; 500 IU\nPulver og solvens til injektionsvæske, opl; 1000 IU\nPulver og solvens til injektionsvæske, opl; 2000 IU"]
["Niraparib","Zejula","GlaxoSmithKline","L01XK02","EMEA/H/C/004249/X/0029","Ny dispenseringsform","Film-coated tablet; 100 mg","2022-05-01",null,"Hårde kapsler; 100 mg"]
["Mepolizumab","Nucala","GlaxoSmithKline","R03DX09","EMEA/H/C/003860/X/0042","Ny styrke","Solution for injection in a pre- filled syringe; 40 mg","2022-05-01",null,"Injektionsvæske, opl. i pen 100 mg\nPulver til injektionsvæske, opl. 100 mg"]
["Siponimod","Mayzent","Novartis","L04AA52","EMEA/H/C/004712/X/0007","Ny styrke","Film-coated tablet; 1 mg","2022-05-01",null,"Filmovertrukne tabletter 0,25 mg\nFilmovertrukne tabletter 2 mg"]
["Baloxavir marboxil","Xofluza","Roche","J05AX25","EMEA/H/C/004974/X/0003/G","Ny styrke","Film-coated tablets; 80 mg","2022-06-01",null,"Filmovertrukne tabletter 20 mg\nFilmovertrukne tabletter 40 mg"]
["Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium","Trydonis","Chiesi Farmaceutici S.p.A.","R03AL09","EMEA/H/C/004702/X/0015","Ny dispenseringsform + styrke","Inhalation powder; 88µg / 5µg / 9µg","2022-07-01",null,"Ikke markedsført i Danmark. "]
["Somapacitan","Sogroya","Novo Nordisk A/S","H01AC07","EMEA/H/C/005030/X/0001/G","Ny styrke","5 mg/1.5 mL (3.3 mg/mL)","2022-07-01",null,"Injektionsvæske, opl. i pen; 10 mg/1,5 ml"]
["Bictegravir / emtricitabine / tenofovir alafenamide","Biktarvy","Gilead Sciences","J05AR20","EMEA/H/C/004449/X/0040/G","Ny styrke","(Film-coated tablets); 30/120/15 mg","2022-07-01",null,"Filmovertrukne tabletter 50/200/25 mg"]
["Mercaptamine","Procysbi","Chiesi Farmaceutici","A16AA04","EMEA/H/C/002465/X/0035","Ny dispenseringsform","Gastro-resistant granules; 75 and 300 mg","2022-08-01",null,"Enterokapsler 25 mg\nEnterokapsler 75 mg"]
["Tildrakizumab","Ilumetri","Almirall S.A","L04AC17","EMEA/H/C/004514/X/0023","Ny styrke","Solution for injection; 200 mg","2022-08-01",null,"Injektionsvæske, opl. i sprøjte 100 mg"]
["Upadacitinib","RINVOQ","AbbVie","L04AA44","EMEA/H/C/004760/X/0012/G","Ny styrke","Prolonged-release tablets; 45 mg","2022-11-01",null,"Depottabletter 15 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"]
[]
["*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. 28-11-2021"]
[]
[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. 13-12-2021"]

{"sheet":"Populationsudvidelser","index":1,"n_rows":36,"n_cols":9,"rows_kept":36,"cut":false,"hidden":false,"merged":[[27,7,28,8],[29,7,30,8],[32,7,32,8],[33,7,33,8]]}
["Ansøgninger om populationsudvidelser* i godkendelsesproces hos EMA"]
[]
["Lægemiddelstof","Produktnavn","Virksomhed","ATC-kode","EMA procedurenummer","Kort indikation","Supplerende information","Est. EU godkendelse","Summary of Opinion"]
["Evolocumab","Repatha","Amgen Europe","C10AX13","EMEA/H/C/003766/II/0049/G","Heterozygous familial hypercholesterolaemia ","Paediatric patients aged 10 years and over","2021-12-01","Summary of Opinion"]
["Posaconazole","Noxafil","Merck Sharp & Dohme B.V.","J02AC04","EMEA/H/C/000610/X/0063/G","Approved indications for Noxafil","Paediatric population","2022-01-01","Summary of Opinion"]
["Dengue tetravalent vaccine (live, attenuated)","Dengvaxia","Sanofi Pasteur","J07BX","EMEA/H/C/004171/II/0012",null,"Paediatric population from 6 years of age","2022-01-01","Summary of Opinion"]
["Ivacaftor / tezacaftor / elexacaftor ","Kaftrio","Vertex Pharmaceuticals","R07AX32","EMEA/H/C/005269/X/0008/G","Pediatric use","Pediatric patients","2022-01-01","Summary of Opinion"]
["Sofosbuvir / velpatasvir","Epclusa","Gilead Sciences Ireland UC","J05AP55","EMEA/H/C/004210/X/0056/G","Chronic hepatitis C virus (HCV) infection","Patients 3 years of age and older","2022-01-01","Summary of Opinion"]
["Dupilumab","Dupixent","Sanofi-Aventis","D11AH05","EMEA/H/C/004390/X/0045/G","Severe asthma with type 2 inflammation","Paediatric patients aged 6 to 11 years old","2022-02-01"]
["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","2022-02-14"]
["Ceftolozane / tazobactam","Zerbaxa","Merck Sharp & Dohme","J01DI54","EMEA/H/C/003772/II/0036","Bacterial infections","Paediatric patients aged birth to less than 18 years","2022-02-22"]
["Daunorubicin / cytarabine","Vyxeos liposomal","Jazz Pharmaceuticals ","L01XY01","EMEA/H/C/004282/II/0018/G","Relapsed/refractory AML in paediatric patients","Paediatric patients","2022-03-01"]
["Brivaracetam","Briviact","UCB Nordic","N03AX23","EMEA/H/C/003898/II/0032/G","","Patients from 1 month to 4 years of age","2022-03-01"]
["Lipegfilgrastim ","Lonquex","Teva B.V.","L03AA14","EMEA/H/C/002556/II/0058/G","(Neutropenia)","Paediatric population","2022-03-01"]
["Lacosamide","Lacosamide UCB","UCB Pharma S.A.","N03AX18","EMEA/H/C/005243/WS2049/0009/G","Partial-onset seizures with or without secondary generalisation","Patients from 1 month to 4 years of age","2022-03-01"]
["Lacosamide","Vimpat","UCB Pharma S.A.","N03AX18","EMEA/H/C/000863/WS2049/0091/G","Partial-onset seizures with or without secondary generalisation","Patients from 1 month to 4 years of age","2022-03-01"]
["Dimethyl fumarate","Tecfidera","Biogen Netherlands B.V.","L04AX07","EMEA/H/C/002601/II/0073","Relapsing remitting multiple sclerosis (RRMS) ","Paediatric patients from 10 years of age and over","2022-03-01"]
["Elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide","Genvoya","Gilead Sciences","J05AR18","EMEA/H/C/004042/X/0079/G","(HIV 1) infection in paediatric patients aged from 2 years and with body weight at least 14 kg.\r\n\r\n","Paediatric patients aged from 2 years and with body weight at least 14 kg","2022-03-11"]
["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","2022-03-16"]
["Exenatide","Bydureon","AstraZeneca","A10BJ01","EMEA/H/C/002020/II/0073","Type 2 diabetes mellitus","Adolescents and children aged 10 years and above","2022-03-16"]
["Doravirine","Pifeltro","Merck Sharp & Dohme","J05AG06","EMEA/H/C/004747/WS2065/0019","HIV","Paediatric population weighing less than 35 kgs","2022-03-19"]
["Doravirine / lamivudine / tenofovir disoproxil","Delstrigo","Merck Sharp & Dohme","J05AR24","EMEA/H/C/004746/WS2065/0026","HIV","Paediatric population weighing less than 35 kgs","2022-03-19"]
["Bupivacaine","EXPAREL liposomal","Pacira Ireland Limited","N01BB01","EMEA/H/C/004586/II/0005","Post-operative pain","Children over 6 years old","2022-05-14"]
["Covid-19 mrna vaccine (nucleosidemodified)","Spikevax","Moderna","J07BX03","Ukendt","To extend the use of Moderna’s COVID-19 vaccine, Spikevax, to children aged 6 to 11.","Children aged 6 to 11","2022-06-10"]
[]
["*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. 28-11-2021"]
[]
[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. 13-12-2021"]