FrancophonIA/ELRC3.0 huggingface dataset:
English: Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Danish: Fortsat behandling bør nøje overvejes hos patienter, der ikke responderer inden for denne tidsperiode.
English: At Week 16, more patients randomised to adalimumab 0.8 mg / kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg / kg eow or MTX (table 20).
Danish: Ved uge 16 havde flere af patienterne, som var randomiseret til adalimumab 0,8 mg/kg, positivt respons for effekt (f.eks.
English: Hefiya is used to treat psoriatic arthritis in adults.
Danish: Hefiya bruges til at behandle psoriasisartrit hos voksne.
English: Pancytopaenia
Danish: Pancytopeni
English: • difficulty sleeping;
Danish: • søvnbesvær
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Danish: Ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis
English: ACR 70 6 months
Danish: ACR 70 uge 52
English: (see section 4.4).
Danish: (se Figur D).
English: If this dose does not work well enough, your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Danish: Hvis den dosis ikke virker godt nok, kan din læge ordinere en startdosis på 160 mg (som fire 40 mg injektioner på en dag eller to 40 mg injektioner på to på hinanden følgende dage) efterfulgt af 80 mg (som to 40 mg injektioner på en dag) to uger senere.
English: The recommended Hefiya induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Danish: Det anbefalede Hefiya dosis-induktionsregime til voksne patienter med moderat til svær colitis ulcerosa er 160 mg i uge 0 (givet som fire 40 mg injektioner på en dag eller som to 40 mg injektioner pr. dag i to på hinanden følgende dage) og 80 mg i uge 2 (givet som to 40 mg injektioner på en dag).
English: a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Danish: Frafald, som skyldtes andet end behandlingssvigt, blev censureret på tidspunktet for frafald.a HR af adalimumab vs placebo ved regressionsanalyse med behandling som baggrundsvariabel.
English: In monotherapy, some patients who experience a decrease in their response to Hefiya 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Danish: Ved behandling med Hefiya alene kan det være en fordel for visse patienter, der oplever faldende respons på Hefiya 40 mg hver anden uge, at øge dosis til 40 mg adalimumab hver uge eller 80 mg hver anden uge.
English: There is no relevant use of Hefiya in children aged less than 2 years in this indication.
Danish: Det er ikke relevant at bruge Hefiya til patienter under 2 år til denne indikation.
English: ACR 20 week 52 62.6 % 54.4 % 72.8 % 0.013 < 0.001 0.043 week 104 56.0 % 49.3 % 69.4 % 0.002 < 0.001 0.140 ACR 50 week 52 45.9 % 41.2 % 61.6 % < 0.001 < 0.001 0.317 week 104 42.8 % 36.9 % 59.0 % < 0.001 < 0.001 0.162 ACR 70 week 52 27.2 % 25.9 % 45.5 % < 0.001 < 0.001 0.656 week 104 28.4 % 28.1 % 46.6 % < 0.001 < 0.001 0.864
Danish: 6 måneder 6,7 % 52,4 % 8,2 % 22,1 % 9,5 % 39,1 % 12 måned NA
English: Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
Danish: Behandling ud over 16 uger skal nøje overvejes hos patienter, som ikke responderer inden for denne tidsperiode.
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Danish: Det er ikke relevant at bruge adalimumab hos børn under 4 år til denne indikation Psoriasisartrit og aksial spondyloartritis inklusive ankyloserende spondylitis Det er ikke relevant at bruge adalimumab til den pædiatriske population til indikationerne ankyloserende spondylitis og psoriatrisartrit.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 personer)
English: • gallbladder inflammation, gallbladder stones;
Danish: • inflammation i galdeblæren, galdesten
English: The syringe inside the pen is made of type I glass with a stainless steel needle, an inner rubber needle cap, and a rubber stopper, containing 0.8 ml solution.
Danish: Sprøjten inden i pennen er lavet af type I-glas med en kanyle i rustfrit stål, en indre kanylehætte i gummi og en gummiprop indeholdende 0,8 ml injektionsvæske.
English: There is no relevant use of adalimumab in children aged less than 6 years for this indication.
Danish: Det er ikke relevant at bruge adalimumab til børn under 6 år til denne indikation.
English: • breaking of finger nails and toe nails;
Danish: • fingernegle og tånegle knækker
English: - If you have any further questions, please ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: • urinary tract infection;
Danish: • urinvejsinfektion
English: The recommended dose of Hefiya for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Danish: Den anbefalede Hefiya-dosis til voksne patienter med uveitis er en startdosis på 80 mg efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis.
English: a adalimumab / MTX 40 mg every other week placebo / MTXadalimumab / MTX (95 % confidence interval b)
Danish: Placebo/ MTXa adalimumab/MTX 40 mg hver anden uge
English: The recommended Hefiya dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Danish: Det anbefalede Hefiya dosisregime til voksne patienter med hidrosadenitis suppurativa (HS) er 160 mg på dag 1 (givet som fire injektioner af 40 mg på en dag eller som to injektioner af 40 mg pr. dag i to på hinanden følgende dage), efterfulgt af 80 mg to uger senere på dag 15 (givet som to injektioner af 40 mg på en dag).
English: Patients treated with adalimumab usually experienced improvement in haematological signs of chronic inflammation.
Danish: Hæmatologiske tegn på kronisk inflammation forbedredes sædvanligvis hos patienter behandlet med adalimumab.
English: • enthesitis-related arthritis,
Danish: • entesopatirelateret artrit
English: How should you store Hefiya?
Danish: Sådan skal du tage Hefiya
English: placebo adalimumab 40 mg eow week 52
Danish: Placebo adalimumab 40 mg hver anden uge uge 52
English: The recommended Hefiya dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection.
Danish: Den anbefalede Hefiya-dosis er 80 mg subkutant i uge 0, efterfulgt af 40 mg subkutant hver anden uge med start 1 uge efter den første dosis.
English: Hepatic or renal impairment
Danish: • alvorligt udslæt eller nældefeber
English: • rheumatoid arthritis,
Danish: • reumatoid artrit
English: There is no relevant use of adalimumab in children aged less than 12 years in this indication.
Danish: Det er ikke relevant at bruge adalimumab hos børn under 12 år til denne indikation.
English: • rash;
Danish: • rysten
English: • Once removed, throw away the cap. Do not try to re-attach the cap.
Danish: • Når hætten er fjernet, så smid den bort.
English: Hefiya 40 mg solution for injection in pre-filled syringe adalimumab
Danish: Hefiya 40 mg injektionsvæske, opløsning i fyldt sprøjte adalimumab
English: joints and other organ systems);
Danish: hjertet, lungerne, leddene og andre organsystemer)
English: Children, adolescents and adults with enthesitis-related arthritis Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Hefiya is 40 mg every other week.
Danish: Børn, unge og voksne fra 6 år, der vejer 30 kg eller mere Den anbefalede dosis Hefiya er 40 mg hver anden uge.
English: The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Danish: Den sædvanlige dosis til voksne med psoriasis er en startdosis på 80 mg (som to 40 mg injektioner på en dag), efterfulgt af 40 mg hver anden uge startende en uge efter den første dosis.
English: Beyond 16 weeks, patients with inadequate response to Hefiya 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Danish: Patienter med utilstrækkeligt respons på Hefiya 40 mg hver anden uge efter 16 ugers behandling eller mere kan have fordel af en stigning i dosis til 40 mg hver uge eller 80 mg hver anden uge.
English: Keep the pre-filled syringe / pre-filled pen in the outer carton in order to protect from light.
Danish: Opbevar den fyldte injektionssprøjte/fyldte pen i den ydre karton for at beskytte mod lys.
English: • sleep interruptions;
Danish: • søvnafbrydelser
English: Hefiya 40 mg solution for injection in pre-filled pen adalimumab
Danish: Hefiya 40 mg injektionsvæske, opløsning i fyldt pen adalimumab
English: • Hefiya pre-filled SensoReady pen/s (see Figure A).
Danish: I din pakning finder du: • Hefiya fyldt(e) Senso-Ready pen(ne) (se Figur A).
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.
Danish: I adalimumab-studier med pædiatriske patienter med uveitis blev der ikke observeret nogen maligniteter hos 60 pædiatriske patienter med en samlet eksposition på 58,4 patientår.
English: The recommended dose of Hefiya for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Danish: Den anbefalede Hefiya-dosis til voksne patienter er en startdosis på 80 mg subkutant, efterfulgt af 40 mg subkutant hver anden uge med start en uge efter den første dosis.
English: One 0.8 ml pre-filled pen contains 40 mg adalimumab.
Danish: En fyldt 0,8 ml pen indeholder 40 mg adalimumab.
English: 5 How to store Hefiya Contents of the pack and other information Instructions for use
Danish: Pakningsstørrelser og yderligere oplysninger Brugsvejledning
English: The recommended dose of Hefiya is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Danish: Den anbefalede startdosis af Hefiya er 80 mg (som to 40 mg injektioner på en dag), efterfulgt af 40 mg hver anden uge startende en uge efter den første dosis.
English: Keep the pre-filled pen in the outer carton in order to protect from light.
Danish: Opbevar den fyldte pen i den ydre karton for at beskytte mod lys.
English: Discontinuation of Hefiya therapy should be considered in patients with confirmed significant haematologic abnormalities.
Danish: Hos patienter med bekræftede signifikante hæmatologiske abnormiteter bør det overvejes at afbryde behandlingen med Hefiya.
English: • dyspepsia (indigestion, bloating, heart burn);
Danish: • sure opstød (fordøjelsesbesvær, oppustethed, halsbrand)
English: • fungal infections;
Danish: • ledinfektioner
English: • kidney problems;
Danish: • nyreproblemer
English: fistula remission3
Danish: ASASa delvis remission
English: The usual Hefiya dose for adults with ulcerative colitis is 160 mg initially (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), then 80 mg (as two 40 mg injections) two weeks later, and then 40 mg every other week.
Danish: Den anbefalede startdosis Hefiya til voksne med colitis ulcerosa er 160 mg (som fire 40 mg injektioner på en dag eller to 40 mg injektioner pr. dag i to på hinanden følgende dage), derefter 80 mg (som to 40 mg injektioner) to uger senere, og herefter 40 mg hver anden uge.
English: • low blood measurements for white blood cells;
Danish: • nedsat antal af hvide blodlegemer
English: • diverticulitis (inflammation and infection of the large intestine);
Danish: • irritation og infektion i tyktarmen (diverticulitis)
English: • abnormal muscle breakdown;
Danish: • unormale muskelssvigt
English: • erythema multiforme (inflammatory skin rash);
Danish: • betændelseslignende hududslæt (erythema multiforme)
English: Posology
Danish: Brugsvejledning
English: 3 defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post-Baseline visits
Danish: 2 immunmodulerende lægemidler kunne kun seponeres ved eller efter uge 26 efter investigators skøn, hvis patienten opfyldte det kliniske responskriterium ³ defineret som lukning af alle fistler, som var åbne ved baseline, ved mindst 2 på hinanden følgende besøg efter baseline-besøget
English: The combination of adalimumab and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Danish: 4.4 “Samtidig administration af biologiske DMARDs eller TNF-antagonister”).
English: MTX N = 110 n (%)
Danish: placebo N=398 N (%)
English: • eye inflammation;
Danish: • betændelse i øjet
English: • dehydration;
Danish: • dehydrering (væskemangel)
English: low dose 20 / 10 mg eow N = 95
Danish: lavdosis 20/10 m g hver anden uge N = 95
English: One 0.8 ml pre-filled syringe contains 40 mg adalimumab.
Danish: En fyldt 0,8 ml sprøjte indeholdende 40 mg adalimumab.
English: The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections on the same day) two weeks later.
Danish: Startdosis ved hidrosadenitis suppurativa er sædvanligvis 160 mg (som fire 40 mg injektioner på en dag eller to 40 mg injektioner pr. dag i to på hinanden følgende dage), efterfulgt af 80 mg (som to 40 mg injektioner på en dag) to uger senere.
English: Headache
Danish: • hårtab
English: • heart attack;
Danish: • hjertetilfælde
English: 36.8 % (14 / 38) 64.9 % (24 / 37)b 43.3 % (13 / 30) 71.4 % (20 / 28)c median time to disease flare
Danish: 6 måneder 3,3 % 23,8 % 1,8 % 12,4 % 2,5 % 20,8 % 12 måned NA
English: • high blood measurements for white blood cells;
Danish: • forhøjet antal hvide blodlegemer
English: Hypertension, flushing, haematoma
Danish: Hypertension, rødme, hæmatom
English: What Hefiya is and what it is used for What you need to know before you use Hefiya How to use Hefiya Possible side effects 5 How to store Hefiya Contents of the pack and other information Instructions for use
Danish: Det skal du vide, før du begynder at tage Hefiya Sådan skal du tage Hefiya Bivirkninger
English: Among those, 64 patients (79.0 %) had ACR 20 responses; 56 patients (69.1 %) had ACR 50 responses; and 43 patients (53.1 %) had ACR 70 responses.
Danish: (69,1 %) ACR 50-respons og 43 patienter (53,1 %) ACR 70-respons.
English: If you use more Hefiya than you should
Danish: Hvis du har taget for meget Hefiya
English: Hospitalisation rates
Danish: Oversigt over indlægssedlen
English: • low blood measurements for platelets;
Danish: • nedsat antal blodplader
English: a assessments in ankylosing spondylitis b
Danish: c baseret på ranganalyse d Ledspalteforsnævring
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of
Danish: I de kontrollerede dele af de pivotale adalimumab-studier med voksne af mindst 12 ugers varighed hos patienter med moderat til svær aktiv reumatoid artrit, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS, psoriasisartrit, psoriasis, hidrosadenitis suppurativa, Crohns sygdom, colitis ulcerosa og uveitis blev der observeret maligniteter, fraset lymfomer og ikke-melanom hudkræft, med en hyppighed (95 % konfidensinterval) på 6,8 (4,4-10,5) pr. 1.000 patientår blandt 5.291 adalimumab-patienter mod en hyppighed på 6,3 (3,4-11,8) pr. 1.000 patientår blandt 3.444 kontrolpatienter (gennemsnitlig varighed af behandlingen var 4,0 måneder for adalimumab og 3,8 måneder for de kontrolbehandlede patienter).
English: • pulmonary embolism (blockage in an artery of the lung);
Danish: • lungefibrose (dannelse af arvæv i lungerne)
English: Leucocytosis, thrombocytopaenia
Danish: Leukocytose, trombocytopeni Ikke almindelig Idiopatisk trombocytopenisk purpura Sjælden
English: adalimumab 40 mg eow N=108 n (%)
Danish: MTX N=110 n adalimumab 40 mg hver anden uge N=108 n (%)
English: Psoriatic arthritis
Danish: Psoriasisartrit
English: • ear infections;
Danish: • øreinfektioner
English: • Slowly press down on the plunger as far as it will go, so that the plunger head is completely between the needle guard wings.
Danish: • Skub langsomt stemplet så langt ned, som det kan komme,
English: Adolescent hidradenitis suppurativa
Danish: Hidrosadenitis suppurativa hos unge
English: Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
Danish: Behandling ud over 12 uger skal nøje genovervejes hos patienter, som ikke responderer inden for denne tidsperiode.
English: p-valuea p-valueb p-valuec
Danish: adalimumab/ MTX n=268 p-værdia p-værdib p-værdic
English: ASASa 20 week 2 week 12 week 24
Danish: ACR 20 uge 12 uge 24
English: Keep the pre-filled pens in the outer carton in order to protect from light.
Danish: Opbevar de fyldte penne i den ydre karton for at beskytte mod lys.
English: Continued therapy should be reconsidered in a patient not responding within this time period.
Danish: Fortsat behandling anbefales ikke til patienter, der ikke responderer inden for denne tidsperiode.
English: If you are unsure, contact your doctor.
Danish: Kontakt lægen, hvis du er i tvivl.
English: Hefiya dose for paediatric patients with uveitis Patient weight
Danish: Hefiya-dosis til pædiatriske patienter med uveitis
English: Solution for injection.
Danish: Injektionsvæske, opløsning.
English: adalimumab 40 mg eow N = 109
Danish: adalimumab 40 mg hver anden uge N=109
English: Keep the pre-filled syringes in the outer carton in order to protect from light.
Danish: Opbevar de fyldte injektionssprøjter i den ydre karton for at beskytte mod lys.
English: • low blood potassium.
Danish: • lavt kalium i blodet.
English: adalimumab 0.8 mg / kg eow N=38
Danish: adalimumab 0,8mg/kg hver anden uge N=38
English: Rash (including exfoliative rash)
Danish: Meget almindelig Udslæt (inklusive eksfoliativt udslæt), Almindelig
English: Surgery
Danish: Kirurgi
English: Each 0.8 ml single-dose pre-filled pen contains 40 mg of adalimumab.
Danish: Hefiya 40 mg injektionsvæske, opløsning i fyldt pen Hver fyldt 0,8 ml enkeltdosis pen indeholder 40 mg adalimumab.
English: Women of child bearing potential
Danish: Kvinder i den fertile alder
English: • raised liver enzymes.
Danish: • forhøjede leverenzymer.
English: 12 months
Danish: 6 måneder 12 måned NA
English: • axial spondyloarthritis without radiographic evidence of ankylosing spondylitis,
Danish: Ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis.
English: Cardiac arrest
Danish: • hjertestop
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Danish: Opbevar injektionssprøjten i den ydre karton for at beskytte mod lys.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: • reproductive tract infections;
Danish: • infektioner i kønsvejene
English: 31 July 2016
Danish: Den 31. juli 2016
English: Date
Danish: Dato
English: 31 March 2014 and annually thereafter
Danish: Den 31. marts 2014 og derefter årligt
English: Conditions
Danish: Betingelser
English: Final study report by:
Danish: Endelig rapport over undersøgelsen skal foreligge senest:
English: Conditions to the marketing authorisation
Danish: Betingelser for markedsføringstilladelsen
English: Annex IV Conditions to the marketing authorisations
Danish: Bilag IV Betingelser for markedsføringstilladelsen
English: • same exposure definition (expressed in 100,000 patients treated - daily dose of 100 mg equivalents),
Danish: • anvende samme definition af eksponering (angivet per 100 000 behandlede patienter - dagsdosis 100 mgækvivalenter),
English: This will highlight the risks and warnings on hypersensitivity reactions (by e.g. a checklist, to be implemented at national level).
Danish: Denne skal fremhæve risici og advarsler vedrørende hypersensitivitetsreaktioner (f.eks. gennem en tjekliste, der gennemføres på nationalt plan).
English: • same data lock point (31st of December of each year),
Danish: • anvende samme skæringsdato for data (31. december hvert år),
English: In order to improve the overall product comparability, the MAHs should have:
Danish: For at forbedre den overordnede sammenlignelighed mellem produkterne skal indehaverne af markedsføringstilladelse:
English: • same event definition (use of the specific PT “Hypersensitivity” and the narrow and broad scope SMQs for “Anaphylactic reactions and angioedema”: the MAHs should confirm their coding convention for capturing symptoms and diagnosis as MedDRA terms)
Danish: • anvende samme definition af hændelse (den specifikke foretrukne betegnelse “hypersensitivitet” og den snævre og brede betydning af MedDRA-søgetermen (SMQ) “Anaphylactic reactions and angioedema”, og angive deres kodningskonvention for registrering af symptomer og diagnose som MedDRA-betegnelser),
English: The study will also have to be reflected in the updated/new RMP submission.
Danish: Denne undersøgelse skal også fremgå af den opdaterede/nye risikostyringsplan.
English: National competent authorities of Member State(s) coordinated by reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaten (medlemsstaterne) eller i givet fald i referencemedlemsstaten sikrer, at indehaverne af markedsføringstilladelse opfylder følgende vilkår:
English: • and use the severity classification according to Ring and Messmer classification.
Danish: • klassificere sværhed efter Ring og Messmer.
English: The MAHs should submit annual cumulative reviews of hypersensitivity case reports, all fatal cases and all pregnancy cases, together with usage data yearly.
Danish: Indehaverne af markedsføringstilladelse indsender en årlig kumulativ oversigt over indberetningsrapporter om hypersensitivitet, alle dødelige tilfælde og alle graviditeter samt oplysninger om lægemiddelanvendelse.
English: The MAHs shall conduct a PASS to further characterise the safety concerns on the hypersensitivity reactions.
Danish: Indehaverne af markedsføringstilladelsen udfører en PASS til nærmere karakterisering af sikkerhedsproblemerne ved hypersensitivitetsreaktioner.
English: The MAHs should update the risk management plan (RMP) for products with an existing RMP to include the additional risk minimisation measures and the additional pharmacovigilance activities agreed as part of this procedure.
Danish: For produkter, for hvilke der foreligger en risikostyringsplan, opdaterer indehaverne af markedsføringstilladelse risikostyringsplanen med de supplerende risikominimeringsforanstaltninger og lægemiddelovervågningsaktiviteter, der er vedtaget som led i denne procedure.