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["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)"]
["Buprenorphine / naloxone","Suboxone","Indivior","N07BC51","EMEA/H/C/000697/X/0042","Ny administrationsvej + dispenseringsform + styrke","Sublingual film; Four new strengths (2/0.5, 4/1, 8/2, and 16/4 mg)","2020-06-01","Summary of Opinion","Resoriblet; 2 mg buprenorphin/0,5 mg naloxon, 8 mg buprenorphin/2 mg naloxon eller 16 mg buprenorphin/4 mg naloxon"]
["Ledipasvir / sofosbuvir","Harvoni","Gilead Sciences Ireland UC","J05AP01","EMEA/H/C/003850/X/0081/G","Ny dispenseringsform + ny styrke","Oral granules; 33.75/150 and 45/200 mg","2020-06-01","Summary of Opinion","Filmovertrukken tablett; 400 mg sofosbuvir/90 mg ledipasvir"]
["Ledipasvir / sofosbuvir","Harvoni","Gilead Sciences Ireland UC","J05AP01","EMEA/H/C/003850/X/0081/G","Ny styrke","Film-coated tablets; 45/200 mg","2020-06-01","Summary of Opinion","Filmovertrukken tablett; 400 mg sofosbuvir/90 mg ledipasvir"]
["Sofosbuvir","Sovaldi","Gilead Sciences Ireland UC","J05AP08","EMEA/H/C/002798/X/0059/G","Ny dispenseringsform+styrke","Granules; 150 and 200 mg","2020-06-01","Summary of Opinion","Filmovertrukken tablett; 400 mg "]
["Sofosbuvir","Sovaldi","Gilead Sciences Ireland UC","J05AP08","EMEA/H/C/002798/X/0059/G","Ny styrke","Film-coated tablets; 200 mg","2020-06-01","Summary of Opinion","Filmovertrukken tablett; 400 mg "]
["Dabigatran etexilate","Pradaxa","Boehringer Ingelheim International GmbH","B01AE07","EMEA/H/C/000829/X/0122/G","Ny dispenseringsform","Coated granules; 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, 150 mg","2020-11-28",null,"Kapsler; 75 mg, 110 mg eller 150 mg "]
["Dabigatran etexilate","Pradaxa","Boehringer Ingelheim International GmbH","B01AE07","EMEA/H/C/000829/X/0122/G","Ny dispenseringsform","Powder and solvent for oral solution; 6.25 mg/ml","2020-11-27",null,"Kapsler; 75 mg, 110 mg eller 150 mg "]
["Albutrepenonacog alfa","IDELVION","CSL Behring GmbH","B02BD04","EMEA/H/C/003955/X/0035","Ny styrke","Powder and solvent for solution for injection; 3500 IU (700 IU/ml)","2020-10-30",null,"Pulver og solvens til injektionsvæske; 250 IE, 500 IE, 1.000 IE eller 2.000 IE "]
["Iron","Velphoro","Vifor Pharma","V03AE05","EMEA/H/C/002705/X/0020/G","Ny dispenseringsform+styrke","Powder for oral suspension; 125mg","2020-10-30",null,"Tyggetablett; 500 mg"]
["Sofosbuvir / velpatasvir","Epclusa","Gilead Sciences","J05AP55","EMEA/H/C/004210/X/0043/G","Ny styrke","Film-coated tablets; 200/50 mg","2020-11-27",null,"Filmovertrukken tablett; 400 mg sofosbuvir/100 mg velpatasvir"]
["Alirocumab","Praluent","Sanofi-aventis groupe","C10AX14 ","EMEA/H/C/003882/X/0054/G","Ny styrke","Solution for injection in pre-filled pen; 300 mg","2020-12-26",null,"Injektionsvæske i fyldt pen; 75 mg eller 150 mg "]
["Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium","Trimbow","Chiesi Farmaceutici S.p.A.","R03AL09 ","EMEA/H/C/004257/X/0008/G","Ny styrke","172 μg / 5 μg / 9 μg","2020-12-26",null,"Inhalationsspray; 87 mikrogram/ 5 mikrogram/9 mikrogram"]
["Dulaglutide","Trulicity","Eli Lilly Nederland B.V.","A10BJ05 ","EMEA/H/C/002825/X/0045","Ny styrke","Solution for injection; 3 mg and 4.5 mg","2020-12-26",null,"Injektionsvæske i fyldt pen; 0,75 mg eller 1,5 mg "]
["Ivacaftor","Kalydeco","Vertex Pharmaceuticals (Ireland) Limited","R07AX02 ","EMEA/H/C/002494/X/0083/G","Ny styrke","Film-coated tablets; 75 mg","2020-12-26",null,"Tabletter; 150 mg ivacaftor\nGranulat i brev; 25 mg, 50 mg eller 75 mg ivacaftor"]
["Tezacaftor / ivacaftor","Symkevi","Vertex Pharmaceuticals (Ireland) Limited","R07AX31 ","EMEA/H/C/004682/X/0015/G","Ny styrke","Film-coated tablets; 50/75mg","2020-12-26",null,"Tabletter; 100 mg tezacaftor/150 mg ivacaftor"]
["Thiotepa","Tepadina","ADIENNE S.r.l.","L01AC01 ","EMEA/H/C/001046/X/0036","Ny dispenseringsform+styrke","Powder and solvent for solution for infusion; 400mg","2020-12-26",null,"Pulver til koncentrat til infusionsvæske; 15 mg eller 100 mg "]
["Bedaquiline","Sirturo","Janssen-Cilag International NV","J04AK05","EMEA/H/C/002614/X/0036/G","Ny styrke","Tablet; 20 mg","2021-01-30",null,"Tabletter; 100 mg "]
["Ravulizumab","Ultomiris","Alexion","L04AA23","EMEA/H/C/004954/X/0004/G","Ny styrke","Concentrate for solution for infusion; 1100 mg","2021-01-30",null,"Koncentrat til infusionsvæske; 300 mg"]
["Rivaroxaban","Xarelto","Bayer","B01AF01","EMEA/H/C/000944/X/0074/G","Ny dispenseringsform+styrke","Granules for oral suspension; 1mg/ml","2021-01-30",null,"Filmovertrukken tablett; 2,5 mg, 10 mg, 15 mg eller 20 mg"]
["Botulinum toxin type a","Nuceiva","Evolus Pharma Limited","M03AX01","EMEA/H/C/004587/X/0005","Ny styrke","Powder for solution for injection in vial (glass); 50 U","2021-02-28",null,"Pulver til injektionsvæske; 100 E"]
["Dolutegravir","Tivicay","ViiV Healthcare","J05AX12","EMEA/H/C/002753/X/0058/G","Ny dispenseringsform+styrke","Dispersible tablet; 5 mg","2021-02-28",null,"Tabletter; 10 mg, 25 mg eller 50 mg "]
["Secukinumab","Cosentyx","Novartis Europharm Limited","L04AC10","EMEA/H/C/003729/X/0059","Ny styrke","Solution for injection (in pre-filled syringe and pre-filled pen); 300 mg","2021-02-28",null,"Injektionsvæske i fyldt pen; 150 mg"]
["Fluticasone furoate / umeclidinium / vilanterol","Elebrato Ellipta","GlaxoSmithKline","R03AL08","EMEA/H/C/004781/X/0014/G","Ny styrke","184 mcg / 55 mcg / 22 mcg","2021-03-27",null,"Ikke markedsført i Danmark. "]
["Fluticasone furoate / umeclidinium / vilanterol","Temybric Ellipta","GlaxoSmithKline","R03AL08","EMEA/H/C/005254/X/0004/G","Ny styrke","184 mcg / 55 mcg / 22 mcg","2021-03-27",null,"Ikke markedsført i Danmark. "]
["Fluticasone furoate / umeclidinium / vilanterol","Trelegy Ellipta","GlaxoSmithKline","R03AL08","EMEA/H/C/004363/X/0012/G","Ny styrke","184 mcg / 55 mcg / 22 mcg","2021-03-27",null,"Inhalationspulver; 92 + 55 + 22 mikrogram"]
["Peginterferon beta-1a","Plegridy","Biogen Netherlands B.V.","L03AB13","EMEA/H/C/002827/X/0056","Ny administrationsvej","Intramuscular use","2021-03-27",null,"Injektionsvæske, opl. i pen; 63 mikrogram, 94 mikrogram eller 125 mikrogram\nInjektionsvæske, opl. i sprøjte; 63 mikrogram, 94 mikrogram eller 125 mikrogram"]
["Stiripentol","Diacomit","Biocodex","N03AX17","EMEA/H/C/000664/X/0032","Ny styrke","Capsules; 100 mg","2021-03-27",null,"Hårde kapsler; 250 mg eller 500 mg\t\nPulver til oral suspension; 250 mg eller 500 mg\t"]
["Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium","Trimbow","Chiesi Farmaceutici S.p.A.","R03AL09 ","EMEA/H/C/004257/X/0012","Ny dispenseringsform + styrke","Inhalation powder; 88µg / 5µg / 9µg","2021-04-26",null,"Inhalationsspray, opløsning; 87 + 5 + 9 mikrogram"]
["Glecaprevir / pibrentasvir","Maviret","AbbVie Deutschland GmbH & Co. KG","J05AP57","EMEA/H/C/004430/X/0033/G","Ny dispenseringsform + styrke","Coated granules in sachet; 50/20 mg","2021-04-26",null,"Filmovertrukne tabletter; 100 + 40 mg"]
["Natalizumab","Tysabri","Biogen Netherlands B.V.","L04AA23","EMEA/H/C/000603/X/0116","Ny administrationsvej + dispenseringsform + styrke","Solution for injection; subcutaneous injection; 150 mg","2021-04-26",null,"Konc. til infusionsvæske, opl.; 300 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. 17-06-2020"]
[]
[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. 24-06-2020"]

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["Ansøgninger om populationsudvidelser* i godkendelsesproces hos EMA"]
[]
["Lægemiddelstof","Produktnavn","Virksomhed","ATC-kode","EMA procedurenummer","Kort indikation","Supplerende information","Est. EU godkendelse","Summary of Opinion"]
["Anidulafungin","ECALTA","Pfizer Europe MA EEIG","J02AX06","EMEA/H/C/000788/II/0040","Invasive candidiasis","Paediatric patients aged from 1 month to less than 18 years of age","2020-06-01","Summary of Opinion"]
["Ivacaftor","Kalydeco","Vertex","R07AX02","EMEA/H/C/002494/II/0082","Cystic fibrosis","Aged 6 years and older and weighing 25 kg or more who have an R117H mutation in the CFTR gene","2020-06-01","Summary of Opinion"]
["Ivacaftor","Kalydeco","Vertex","R07AX02","EMEA/H/C/002494/II/0082","Cystic fibrosis","Patients with CF aged 12 months and older and weighing 7 kg to less than 25 kg who have an R117H mutation in the CFTR gene.","2020-06-01","Summary of Opinion"]
["Ledipasvir / sofosbuvir","Harvoni","Gilead Sciences Ireland UC","J05AP01","EMEA/H/C/003850/X/0081/G","Chronic hepatitis C (CHC) in patients aged 3 to <12 years","Paediatric use in patients aged 3 to < 12 years who weigh greater than or equal to 35 kg to the existing presentations of 90/400 mg film-coated tablets.","2020-06-01","Summary of Opinion"]
["Sofosbuvir","Sovaldi","Gilead Sciences Ireland UC","J05AP08","EMEA/H/C/002798/X/0059/G","Chronic hepatitis C ","Patients aged 3 to <12 years","2020-06-01","Summary of Opinion"]
["Ixekizumab","Taltz","Eli Lilly Nederland B.V","L04AC13","EMEA/H/C/003943/II/0031","Plaque psoriasis","Children from the age of 6 years and adolescents","2020-07-01","Summary of Opinion"]
["Tedizolid phosphate","Sivextro","Merck Sharp & Dohme B.V.","J01XX11","EMEA/H/C/002846/II/0035","ABSSSI","Adolescent population from 12 years old and older","2020-07-01","Summary of Opinion"]
["Meningococcal group B vaccine","Trumenba","Pfizer Europe MA EEIG","J07AH09","EMEA/H/C/004051/II/0013","Meningococcal group B vaccine","Children 1-9 years old","2020-09-26"]
["Sodium oxybate","Xyrem","UCB Pharma S.A.","N07XX04","EMEA/H/C/000593/II/0076","Extension of Indication to include adolescents and children older then 7 years for Xyrem","Adolescents and children older than 7 years","2020-09-27"]
["Perampanel","Fycompa","Eisai GmbH","N03AX22","EMEA/H/C/002434/II/0047","Partial-Onset (focal) Seizures with or without secondary generalisation and Primary Generalised Tonic-Clonic Seizures with idiopathic generalised epilepsy","Paediatric patients from 2 to 11 years of age","2020-09-28"]
["Ceftazidime / avibactam","Zavicefta","AstraZeneca AB","J01DD52","EMEA/H/C/004027/II/0015","Treatment of cIAI and cUTI","Paediatric patients aged 3 months to less than 18 years ","2020-09-26"]
["Everolimus","Votubia","Novartis Europharm Limited","L01XE10","EMEA/H/C/002311/II/0061","Partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex, TSC","Patients from 6 months to less than 2 years of age.","2020-09-12"]
["Burosumab","CRYSVITA","Kyowa Kirin Limited","M05BX05","EMEA/H/C/004275/II/0010/G","Adults with X-linked hypophosphataemia (XLH)","Adults","2020-09-30"]
["Iron","Velphoro","Vifor Pharma","V03AE05","EMEA/H/C/002705/X/0020/G","CKD","Paediatric patients 2 years of age and older","2020-09-30"]
["Dabigatran etexilate","Pradaxa","Boehringer Ingelheim International GmbH","B01AE07","EMEA/H/C/000829/X/0122/G","(Anticoagulant)","Pediatric","2020-09-27"]
["Delamanid","Deltyba","Otsuka Novel Products GmbH","J04AK06 ","EMEA/H/C/002552/II/0040","(Tuberculosis) ","Adolescents and children above 6 years with a body weight of at least 30 kg","2020-09-27"]
["Secukinumab","Cosentyx","Novartis Europharm Limited","L04AC10 ","EMEA/H/C/003729/II/0057","Plaque psoriasis","Children and adolescents from the age of 6 years","2020-09-27"]
["Sofosbuvir / velpatasvir","Epclusa","Gilead Sciences","J05AP55","EMEA/H/C/004210/X/0043/G","Chronic hepatitis C (CHC)","Paediatric use in patients aged 6 to < 18 years who weigh greater than or equal to 35 kg to the existing presentation (400/100 mg film-coated tablets)","2020-09-27"]
["Ivacaftor","Kalydeco","Vertex Pharmaceuticals (Ireland) Limited","R07AX02 ","EMEA/H/C/002494/X/0083/G","Cystisk fibros","Children aged 6 to less than 11 years","2020-09-26"]
["Lurasidone","Latuda","Sunovion Pharmaceuticals Europe Ltd ","N05AE05","EMEA/H/C/002713/II/0029","Schizophrenia","Adolescent from 13 to less than 18 years","2020-09-26"]
["Tezacaftor / ivacaftor","Symkevi","Vertex Pharmaceuticals (Ireland) Limited","R07AX31 ","EMEA/H/C/004682/X/0015/G","(Cystic fibrosis)","Patients aged 6 to less than 11 years.","2020-09-26"]
["Bedaquiline","SIRTURO","Janssen-Cilag International NV","J04AK05","EMEA/H/C/002614/X/0036/G","(Tuberculosis)","Paediatric patients aged from 5 years to less than 18 years of age and weighing more than 15 kg","2020-08-30"]
["Rivaroxaban","Xarelto","Bayer","B01AF01","EMEA/H/C/000944/X/0074/G","Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence","Neonates, infants and toddlers, children, and adolescents aged less than 18 years","2020-08-30"]
["Dolutegravir","Tivicay","ViiV Healthcare","J05AX12","EMEA/H/C/002753/X/0058/G","HIV","The new presentation is indicated for the treatment of HIV infected children from 4 weeks of life and weighing at least 3 kilograms.","2020-09-28"]
["Dupilumab","Dupixent","Sanofi-aventis groupe","D11AH05","EMEA/H/C/004390/II/0027","Atopic dermatitis ","Patients from 6 years to 11 years","2020-09-27"]
["Herpes zoster vaccine (recombinant, adjuvanted)","Shingrix","GlaxoSmithkline Biologicals SA","J07BK03","EMEA/H/C/004336/II/0022","(Vaccine used to protect against shingles and post-herpetic neuralgia)","Adults 18 years of age or older at increased risk of Herpes Zoster ","2020-09-27"]
["Glecaprevir / pibrentasvir","Maviret","AbbVie","J05AP57","EMEA/H/C/004430/X/0033/G","Chronic hepatitis C infection","Children from 3 to 12 years of age","2020-10-26"]
["Darunavir","Prezista","Janssen-Cilag International NV","J05AE10","EMEA/H/C/000707/II/0107","HIV-1 infection","Aged 12 years and older with body weight at least 40 kg","2020-11-30"]
[]
["*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. 17-06-2020"]
[]
[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. 24-06-2020"]