natgillin/translations-raw huggingface dataset:
Ethinylestradiol er et syntetisk østrogen, mens dienogest er et nortestosteron-derivat, der unikt indeholder en cyanomethylgruppe i position 17α.
Ethinylestradiol is a synthetic estrogen while dienogest is a nortestosterone derivative which uniquely contains a cyanomethyl group at position 17α.
På baggrund af dette og af nødvendigheden af at gribe ind på EU-plan fandt Det Forenede Kongerige det i Unionens interesse at indbringe sagen for CHMP, og anmodede den 18. februar 2016 udvalget om i henhold til artikel 31 i direktiv 2001/83/EF at udtale sig om, hvorvidt markedsføringstilladelserne for disse produkter til ovennævnte indikation bør opretholdes, ændres, suspenderes eller inddrages i forbindelse med nedenstående indikation:
In view of the above and the necessity to take an action at EU level, UK considered that it was in the interest of the Union to refer the matter to the CHMP and requested on the 18 February 2016, that it give its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products in the abovementioned indication should be maintained, varied, suspended, or revoked in relation to the below indication:
Det vides ikke, om risikoen for VTE med DNG/EE er mindre eller større end med de kombinerede orale kontraceptiva indeholdende levonorgestrel (5-7 pr. 10 000 kvinder), etonogestrel (6-12 pr. 10 000 kvinder) eller drospirenon (9-12 pr. 10 000 kvinder), sammenholdt med 2 ud af 10 000, som ikke bruger et kombineret hormonalt kontraceptivum.
It is not known if the risk of VTE with DNG/EE is better or worse than that of the combined oral contraceptives containing levonorgestrel (5-7 per 10,000 women), etonorgestrel (6-12 per 10,000 women) or drospirenone (9-12 per 10,000 women as compared to 2 out of 10,000 women who do not use a combined hormonal contraceptive).
Dienogest har ikke nævneværdig androgen-, mineralokortikoid- eller glukokortikoidvirkning in vivo.
Dienogest does not have significant androgen, mineralocorticoid or glucocorticoid effects in vivo.
Den kontraceptive virkning af denne kombination bygger på samspillet mellem en række virkninger, hvoraf den vigtigste anses for at være ovulationshæmning og ændringer i cervixsekretet.
The contraceptive effect of this combination is based on the interaction of various effects, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion.
• CHMP fandt, at patienter, der behandles for acne, bør vurderes 3-6 måneder efter påbegyndelse af behandlingen og derefter periodisk.
• The CHMP agreed that patients treated for acne should be assessed 3-6 months after starting treatment and periodically thereafter.
Kombinerede orale kontraceptiva menes at give bedring i acne gennem flere mekanismer.
Combined oral contraceptives (COCs) are thought to improve acne by several mechanisms.
Dienogest udviser antiandrogene egenskaber og har 10-30 gange lavere in vitro-affinitet til progesteronreceptoren end andre syntetiske progestogener.
Dienogest shows antiandrogenic properties, 10-30 fold lower affinity to progesterone receptor in vitro as compared to other synthetic progestogens.
Orale kontraceptiva kan desuden påvirke knoglemetabolismen hos unge, skønt denne virkning må forventes at være reversibel efter seponering af behandlingen.
Oral contraceptives may also affect bone metabolism in adolescents, although this effect is likely reversible after discontinuation of treatment.
Dette er i overensstemmelse med de gældende behandlingsretningslinjer, der fastslår, at kombinerede orale kontraceptiva ikke er indiceret ved let acne, men anses for behandlingsalternativer hos kvinder med moderat til svær acne.
This is in line with the current treatment guidelines which state that combined oral contraceptives (COCs) are not indicated in mild acne, but are considered as treatment alternatives in females with moderate to severe acne.
De kliniske fase III-undersøgelser omhandlede overvejende moderat acne vulgaris.
The phase III clinical studies showed that predominantly moderate acne vulgaris dominated in the studies.
Benefit/risk-forholdet for DNG/EE anses derfor for at være gunstigt som andetvalgsbehandling af kvinder med moderat acne.
Therefore, the benefit-risk relationship of DNG/EE is considered favourable for a second-line treatment of women with moderate acne.
"Behandling af moderat svær acne hos kvinder, der ikke har kontraindikationer for orale kontraceptiva, og hos hvem topikal behandling har været ineffektiv".
“Treatment of acne with moderate severity in women without contraindications for oral contraceptives and in whom topical treatment was ineffective”.
Ved gennemgang af de foreliggende data til støtte for virkningen af dienogest/ethinylestradiol konkluderede CHMP, at der overordnet er tilstrækkelig evidens til at underbygge anvendelsen af denne kombination ved acneindikationen.
When considering existing data in support of the efficacy of dienogest/ethinylestradiol, the CHMP concluded that overall there is sufficient evidence in support of the use of this combination in the acne indication.
• CHMP bemærkede, at risikoen for VTE med kombinerede hormonale kontraceptiva indeholdende dienogest endnu ikke er færdigkarakteriseret.
• The CHMP noted that the risk of VTE with dienogest containing combined hormonal contraceptive is not yet fully characterised.
Risikoen for venøse tromboemboliske hændelser og arterielle tromboemboliske hændelser er særlig vigtig, da der hidtil ikke har været tilstrækkelige data til klart at fastlægge den relative risiko for tromboemboliske hændelser i forhold til andre kombinerede hormonale kontraceptiva, der indeholder andre progestogener.
The risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE) is of particular importance as to date there is insufficient data to clearly determine the relative risk for thromboembolic events compared to other combined hormonal contraceptives containing other progestogens.
• CHMP gennemgik proceduren i henhold til artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende dienogest (DNG), 2 mg, og ethinylestradiol (EE), 0,03 mg, til moderat svær acne hos kvinder, hos hvem topikal behandling har været ineffektiv,
• The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for medicines containing dienogest (DNG) 2 mg and ethinylestradiol (EE) 0.03 mg for moderately severe acne in women in whom topical treatment was ineffective.
De foreliggende sikkerhedsdata bekræftede, at bivirkningsprofilen af DNG/EE og sammenligningsprodukterne i fase III-undersøgelserne svarer nøje til hinanden, og at ingen af sikkerhedsparametrene giver anledning til betænkelighed.
The available safety data confirmed that the adverse event (AE) profile of DNG/EE and the comparator products in the phase III trials is very similar, with none of the safety parameters raising any concerns.
Denne konklusion byggede på, at det er nødvendigt at behandle i mindst 3 måneder, for at der kan ses en virkning, og at den mest fremtrædende virkning på acne ses efter 6 måneders behandling (hvilket underbygges af resultaterne af begge fase III-undersøgelse), og at kvinder i betragtning af den endnu ikke kvantificerede risiko for VTE bør vurderes periodisk med henblik på nødvendigheden af at fortsætte behandlingen,
This conclusion was reached considering that treatment would be necessary for at least 3 months for an effect to be seen, with the most prominent effect on acne seen after 6 months of treatment (as supported by the results of both phase III studies), and that in view of the still to be quantified risk of VTE, women should be assessed periodically to review the need for continuation of treatment.
I betragtning af sygdommens art, de iagttagne fordele og de relative risici i forhold til tilgængelige behandlingsalternativer og anbefalingerne i retningslinjer bør lokal eller oral behandling med antibiotika forsøges først, inden der anvendes kombinerede orale kontraceptiva.
Considering the nature of the disorder, the observed benefits and the relative risks compared to available treatment alternatives and guideline recommendations, local therapies or oral antibiotic treatment should be tried first before resorting to a COC.
• CHMP gennemgik alt foreliggende materiale i form af kliniske undersøgelser, publiceret litteratur og erfaringer efter markedsføring, herunder markedsføringstilladelsesindehavernes besvarelser om virkningen af DNG/EE til behandling af acne og om disse lægemidlers sikkerhed, navnlig risikoen for venøse tromboemboliske hændelser (VTE) og arterielle tromboemboliske hændelser (ATE),
• The CHMP considered the totality of the available clinical studies, published literature and postmarketing experience, including responses from marketing authorisation holders (MAHs) on the efficacy of DNG/EE in the treatment of acne, and on the safety of these medicines, in particular regarding the risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE).
• CHMP bemærkede også, at den oprindelige indikation var for bred og unødigt ville udsætte kvinder for en behandling med højere potentiel risiko for VTE, skønt der findes andre og sikrere behandlingsmuligheder for acne.
• The CHMP also noted that the initial acne indication was too broad and would unnecessarily expose women to a treatment with a potential higher risk of VTE when alternative and safer options for the treatment of acne are available.
I betragtning af, at den mest fremtrædende virkning på acne ses efter 6 måneders behandling, og at VTE-risikoen endnu ikke er kvantificeret, bør kvinder vurderes 3-6 måneder efter initiering af behandlingen og derefter periodisk med henblik på nødvendigheden af fortsat behandling.
In view of the most prominent effect on acne seen after 6 months of treatment, paired with the still to be quantified risk of VTE, women should be assessed 3-6 months after initiating treatment and periodically thereafter to review the need for continuation of treatment.
• CHMP er af den opfattelse, at fordelene ved lægemidler indeholdende dienogest/ethinylestradiol fortsat opvejer risiciene til andetvalgsbehandling af moderat acne hos kvinder, der vælger at bruge et oralt kontraceptivum, forudsat at lægemidlerne kun bruges, efter at egnede topikale behandlinger eller orale antibiotika har slået fejl.
• The CHMP is of the opinion that the benefits of dienogest/ethinylestradiol containing medicinal products continue to outweigh the risks in the second-line treatment of moderate acne in women who elect to use an oral contraceptive, provided that the medicinal products are only used after suitable topical therapies or oral antibiotic treatments have failed.
Da Det Forenede Kongerige indbragte sagen, fandt det, at benefit/risk-forholdet for acneindikationen ikke var positivt på grund af utilstrækkelige data om virkningen af kombinationen ved acneindikationen, en uacceptabel sikkerhedsprofil, navnlig hvad angår risikoen for venøse tromboemboliske hændelser (VTE), og det forhold, at målpopulationen for ovennævnte indikation er bred og unødigt udsætter kvinder for en behandling med begrænset virkning og potentielt højere VTErisiko, selv om der findes andre og sikrere behandlingsmuligheder for acne.
At the time of triggering the referral, the UK considered that the benefit-risk analysis for the acne indication was not favourable based on insufficient data on the efficacy of the combination in the acne indication, an unacceptable safety profile, in particular regarding to the risk of venous thromboembolic events (VTE) and the fact that the target population covered by the abovementioned indication is broad and would unnecessarily expose women to a treatment with limited efficacy and to a potential higher risk of VTE when alternative and safer options for the treatment of acne are available.
CHMP fandt derfor, at indikationen bør begrænses til kvinder, som vælger at bruge et oralt kontraceptivum, og at valget af det pågældende kontraceptivum bør være bevidst og velovervejet,
The CHMP therefore agreed that the indication should be restricted to women who elect to use an oral contraceptive, and that a conscious and well-considered decision needs to be made when choosing this COC.
CHMP anbefaler derfor ændring af betingelserne for markedsføringstilladelserne for lægemidler indeholdende dienogest/ethinylestradiol.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for dienogest/ethinylestradiol containing medicinal products indicated in acne.
CHMP bemærkede imidlertid, at der ikke forekom tilfælde af VTE i fase III-undersøgelserne, og at sikkerhedsdataene fra markedsføringstilladelsesindehaverne ikke gav anledning til nye sikkerhedsmæssige betænkeligheder.
However, the CHMP noted that there were no cases of VTE in the phase III studies and the safety data provided by MAHs does not raise any new safety concern.
• CHMP fandt, at virkningen af lægemidler indeholdende dienogest, 2 mg, og ethinylestradiol, 0,03 mg, til behandling af moderat svær acne hos kvinder, hos hvem topikal behandling eller oralt antibiotikum ikke var effektivt, er velunderbygget med kliniske fase III-undersøgelser og støttes yderligere af en Cochrane-gennemgang af kombinerede orale kontraceptiva til behandling af acne,
• The CHMP considered that the efficacy of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg in the treatment of moderately severe acne in women in whom topical treatment or oral antibiotic was ineffective is well supported by phase III clinical trial data and further supported by a Cochrane review of combined oral contraceptive pills for treatment of acne.
CHMP bemærkede desuden, at for at undgå unødig eksponering af kvinder for en behandling med højere potentiel risiko for VTE end andre, sikrere behandlinger af acne bør indikationen indskrænkes til kvinder, der vælger kontraception, og at valg af det pågældende kombinerede orale kontraceptivum bør være bevidst og velovervejet.
The CHMP also noted that in order to avoid unnecessarily exposing women to a treatment with a potential higher risk of VTE when alternative and safer options for the treatment of acne are available that the indication should be restricted to women who elect contraception, and that a conscious and wellconsidered decision needs to be made when choosing this COC.
På ovenstående baggrund konkluderede CHMP, at benefit/risk-forholdet for lægemidler indeholdende dienogest/ethinylestradiol er positivt, forudsat at produktinformationen ændres som beskrevet ovenfor.
In view of the above, the CHMP concluded that the benefit-risk balance of dienogest/ethinylestradiol containing products indicated in acne is favourable subject to changes to the product information as described above.
CHMP finder følgelig, at benefit/risk-forholdet fortsat er positivt for lægemidler, der indeholder dienogest/ethinylestradiol og er indiceret til acne, forudsat at der foretages ovennævnte ændringer af produktinformationen.
The CHMP, as a consequence, considers that the benefit-risk balance of dienogest/ethinylestradiol containing medicinal products indicated in acne remains favourable subject to the amendments to the product information described above.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Graspa (eryaspase)
Withdrawal of the marketing authorisation application for Graspa (eryaspase)
Asparaginase er et enzym, der har været anvendt til behandling af kræft i mange år, og det fås allerede under forskellige handelsnavne i EU.
Asparaginase is an enzyme that has been used to treat cancer for many years, and is already approved under various trade names in the EU.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Graspa (eryaspase) EMA/817193/2016
Withdrawal of the marketing authorisation application for Graspa (eryaspase) EMA/817193/2016
Den 14. november 2016 meddelte Erytech Pharma SA officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Graspa til behandling af akut lymfoblastær leukæmi.
On 14 November 2016, Erytech Pharma SA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia.
Lægemidlet forventedes anvendt hos patienter, hvis kræft er klassificeret som "Philadelphia chromosome negative" og ikke reagerer på den indledende behandling eller vender tilbage efter behandling.
The medicine was intended for use in patients whose cancer was classed ‘Philadelphia chromosome negative' and had not responded to initial treatment, or had come back after treatment.
Desuden havde virksomheden ændret den måde, som asparaginase fremstilles på, og udvalget bad om understøttende dokumentation for, at dette ikke ville have indflydelse på virkningen af lægemidlet.
In addition, the company had changed the way the asparaginase in the medicine was made, and the Committee asked for supportive information to show that this would not affect the effectiveness of the product.
Graspa er et kræftlægemiddel, der indeholder det aktive stof eryaspase (en version af enzymet asparaginase, der befinder sig inde i røde blodlegemer, som er kompatible med patientens blodgruppe).
Graspa is a cancer medicine that contains the active substance eryaspase (a version of the enzyme asparaginase enclosed in red blood cells compatible with the patient's blood group).
Graspa skulle anvendes i tillæg til andre kræftlægemidler til behandling af voksne og børn fra 1 år og opefter, som har akut lymfoblastær leukæmi (ALL), der er en form for kræft i de hvide blodlegemer.
Graspa was expected to be used in combination with other cancer medicines to treat adults and children over 1 year of age who have acute lymphoblastic leukaemia (ALL), a cancer of white blood cells.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Graspa?
What consequences does this withdrawal have for patients in clinical trials?
producere deres egen asparagin og påvirkes mindre af lægemidlet.
Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.
I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den trak ansøgningen tilbage, fordi den ikke kunne fremskaffe de yderligere data, som CHMP anså for nødvendige til at underbygge ansøgningen, inden for den angivne tidsfrist.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because the additional data the CHMP considered necessary to support the application could not be obtained in the time available.
Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at virksomheden ikke havde fremlagt tilstrækkelige oplysninger til at underbygge ansøgningen om Graspa.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Graspa.
Asparaginasen i Graspa ligger inde i røde blodlegemer, der skal hjælpe med at beskytte enzymet mod at blive nedbrudt i kroppen.
The asparaginase in Graspa is enclosed in red blood cells with the intention of helping protect the enzyme from being broken down in the body.
Virksomheden fremlagde data om Graspa, herunder resultaterne af en hovedundersøgelse af 80 patienter med akut lymfoblastær leukæmi, hvis sygdom var vendt tilbage efter den indledende behandling, eller som ikke havde reageret på den indledende behandling.
The company provided data on Graspa, including the results of a main study involving 80 patients with ALL whose disease had come back after initial treatment or who had not responded to initial treatment, some of whom had an allergy to other products containing asparaginase.
Udvalget var ligeledes betænkelig ved, om resultaterne af undersøgelsen kunne udvides til patienter, der tog andre kombinationer af kræftlægemidler.
The CHMP was concerned about the way the effectiveness of the medicine had been measured in the main study, and whether the results of this study could be extended to patients taking other combinations of cancer medicines.
Da asparaginase er et protein, kan det forårsage allergiske reaktioner, men ved at kapsle det ind i røde blodlegemer forventes risikoen for allergi at være reduceret.
it can cause allergic reactions, but by enclosing it in red blood cells the risk of allergy is expected to be reduced.
På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP haft visse betænkeligheder og var af den foreløbige opfattelse, at Graspa ikke kunne være blevet godkendt til behandling af akut lymfoblastær leukæmi.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Graspa could not have been approved for the treatment of ALL.
Graspa blev udpeget som "lægemiddel til sjældne sygdomme" den 26. oktober 2006 mod akut lymfoblastær leukæmi.
Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 October 2006 for ALL.
Det aktive stof i Graspa, asparaginase, virker ved at nedbryde aminosyren asparagin og dermed nedsætte koncentrationen i blodet.
The asparaginase in Graspa works by breaking up and reducing the blood levels of the amino acid asparagine.
Kræftcellerne behøver denne aminosyre for at vokse og formere sig.
Cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die.
* efavirenz / emtricitabin / tenofovirdisoproxil (som fumarat)
* efavirenz / emtricitabine / tenofovir disoproxil (as fumarate)
EU-nummer.
EU number
Lægemiddelform Administrationsvej Emballage
Pharmaceutical Form Route of administration Packaging
3 x 30 filmovertrukne tabletter
3 x 30 film-coated tablets
Der var fortsat gavnlig virkning efter længerevarende behandling i et år.
Benefit continued to be seen with longer term treatment for 1 year.
Efter startdosen gives Imraldi sædvanligvis hver anden uge, men kan dog i visse tilfælde gives hver uge.
After the starting dose, Imraldi is most often given every two weeks, but it may be given every week in certain situations.
Den fuldstændige EPAR for Imraldi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Imraldi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Imraldi.
This is a summary of the European public assessment report (EPAR) for Imraldi.
Efter 24 ugers behandling var responsen en forbedring på 20 % eller mere i symptomscoren: 68 % af dem, der fik Imraldi responderede (183 ud af 269 patienter), sammenlignet med 67 % af dem, der fik Humira (184 ud af 273 patienter).
Response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 68% of those given Imraldi responded (183 of 269 patients), compared with 67% of those given Humira (184 of 273 patients).
Andre oplysninger om Imraldi
Other information about Imraldi
Patienter får også udleveret et særligt patientinformationskort.
An alert card will also be given to patients.
Det betyder, at Imraldi meget nøje svarer til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i Den Europæiske Union (EU).
This means that Imraldi is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Referencelægemidlet for Imraldi er Humira.
The reference medicine for Imraldi is Humira.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Imraldi ?
What measures are being taken to ensure the safe and effective use of Imraldi?
Dosen afhænger af sygdommen, der skal behandles, og hos børn skal den typisk beregnes ud fra barnets vægt og højde.
The dose depends on the condition to be treated and in children is usually calculated according to the child's weight and height.