natgillin/translations-raw huggingface dataset:
De to bioækvivalensundersøgelser blev udført med Mifegyne (godkendt i EØS) og Mifeprex (godkendt i USA). 
The two bioequivalence studies were performed against Mifegyne (approved in EEA) and Mifeprex (approved in the USA).
CHMP bemærkede desuden, at undersøgelsen med Mifeprex påviser bioækvivalensen for både AUC og Cmax. 
In addition, the CHMP noted that the study with Mifeprex demonstrates bioequivalence for both AUC and Cmax.
• Udvalget mente, at de forelagte undersøgelser har påvist den overordnede virkning og sikkerhed. 
• The Committee considered that the overall efficacy and safety have been proven by the studies presented ;
Det forhold, at oralt misoprostol og ikke vaginal gemeprost (som foreslået i den nuværende ansøgning) blev anvendt som opfølgende behandling, ville tværtimod sænke succesraten, hvilket således er betryggende for CHMP. 
The fact that buccal misoprostol and not vaginal gemeprost (as proposed in the current application) was used as follow up treatment would, if anything, lower the success rates and therefore is reassuring to the CHMP.
• Udvalget har gennemgået alle tilgængelige data indsendt af indehaveren af markedsføringstilladelsen med henblik på at vurdere den potentielle alvorlige risiko for folkesundheden, navnlig virkningen af og sikkerheden ved en dosering på 200 mg Mifepristone Linepharma. 
• The Committee reviewed all available data submitted by the marketing authorisation holder to address the potential serious risk to public health, in particular the efficacy and safety in respect of the 200 mg Mifepristone Linepharma dosing regimen;
I hele populationen var succesraten (fuldstændig afbrydelse, intet behov for yderligere kirurgiske indgreb) 96,7 %. 
(complete termination, no need for additional surgical procedure) was 96.7%.
Bioækvivalens med referencelægemidlet (Mifegyne) blev godtgjort for AUC, hvorimod Cmax lå lidt uden for det almindelige acceptinterval på 80-125 % (Cmax (90 % CI) lå på 114,4 (103,33-126,66)). 
Bioequivalence with the reference product (Mifegyne) was demonstrated for AUC while the Cmax was slightly above the conventional acceptance range of 80-125% (the Cmax ratio (90% CI) was 114.4 (103.33-126.66)).
Under den efterfølgende procedure for indbringelse af sager for CMDh nåede parterne ikke til enighed, og CMDh henviste sagen til CHMP gennem indsigelsesproceduren i henhold til artikel 29, stk. 4. 
During the following CMDh-referral procedure no consensus was reached and the CMDh referred the matter to the CHMP through an article 29(4) referral procedure.
Indehaveren af markedsføringstilladelsen har fremlagt kliniske data om virkning og sikkerhed på baggrund af to undersøgelser, der begge blev udført med Mifepristone Linepharma i henholdsvis Mexico og Australien. 
The marketing authorisation holder has provided clinical efficacy and safety data from 2 studies, performed both with Mifepristone Linepharma in Mexico and Australia respectively.
Under proceduren for gentagen anvendelse gjorde Frankrig indsigelse og påpegede, at der var en potentiel alvorlig risiko for folkesundheden, da bioækvivalensen med referencelægemidlet ikke var blevet påvist for Cmax. 
During the repeat use procedure potential serious risk to public health was raised by the France as bioequivalence with the reference product had not been demonstrated for Cmax.
CHMP fremsatte desuden en række andre specifikke bemærkninger vedrørende metoden, bl.a. vedrørende de ordinerende lægers repræsentativitet, populationsstørrelsen og inklusionskriterier. 
Some other specific methodological comments were also raised by the CHMP such as representativity of prescribers, sample size and inclusion criteria.
Videnskabelige konklusioner og begrundelser for positiv udtalelse underlagt betingelse for markedsføringstilladelsen og ændring af produktresumé og indlægsseddel fremlagt af Det Europæiske Lægemiddelagentur 
Scientific conclusions and grounds for positive opinion subject to condition to the marketing authorisation and amendment of the summary of product characteristics and package leaflet presented by the European Medicines Agency
Ansøgningen for 200 mg tabletter Mifepristone Linepharma er en hybridansøgning indgivet i henhold til artikel 10, stk. 3, i direktiv 2001/83/EF med Mifegyne 200 mg tabletter som referencelægemiddel. 
The application for Mifepristone Linepharma 200 mg tablets is a hybrid application made according to Article 10(3) of Directive 2001/83/EC, with Mifegyne 200 mg tablet as reference product.
Den kliniske dokumentation fremlagt af indehaveren af markedsføringstilladelsen til støtte for denne ansøgning i henhold til artikel 10, stk. 3, omfatter kliniske data og understøttende farmakokinetiske data i form af to bioækvivalensundersøgelser. 
The clinical documentation submitted by the MAH to support this article 10(3) application includes clinical data and supportive pharmacokinetic data in the form of two bioequivalence studies.
Indehaveren af markedsføringstilladelsen var enig i ændringerne af punkt 4.2 i produktresuméet og punkt 3 i indlægssedlen som foreslået af CHMP. 
The marketing authorisation holder was in agreement with the amendments of the section 4.2 of the SmPC and section 3 of the Package Leaflet as proposed by the CHMP.
Ansøgningen for Mifepristone Linepharma er en hybridansøgning. 
Mifepristone Linepharma is submitted as a hybrid application.
CHMP havde imidlertid stadig visse betænkeligheder vedrørende de krævede undersøgelser af den potentielle risiko for anden anvendelse af mifepriston end den foreskrevne, enten anvendelse af en højere dosis eller en kombination med en anden prostaglandinanalog end gemeprost vaginalt. 
However the CHMP expressed some remaining concerns with regards to the required investigations on the potential risk of off label use of mifepristone, either using a higher dose or a combination with another prostaglandin analogue than gemeprost per vaginam.
CHMP er af den opfattelse, at indehaveren af markedsføringstilladelsen skal indsende en revideret protokol til de nationale kompetente myndigheder til endelig godkendelse inden indledningen af den kliniske undersøgelse. 
The CHMP is of the opinion that the marketing authorisation holder should submit a revised protocol to the national competent authorities, for final agreement prior the start of the clinical trial.
Indehaveren af markedsføringstilladelsen fremlagde desuden understøttende farmakokinetiske data i form af to bioækvivalensundersøgelser. 
In addition, the MAH provided supportive pharmacokinetic data in the form of two bioequivalence studies.
Begrundelser for positiv udtalelse underlagt betingelse for markedsføringstilladelsen og ændring af produktresumé og indlægsseddel 
Grounds for positive opinion subject to condition to the marketing authorisation and amendment of the summary of product characteristics and package leaflet
CHMP er således af den opfattelse, at der skal indsendes en revideret protokol til de nationale kompetente myndigheder til endelig godkendelse inden indledningen af den kliniske undersøgelse som en betingelse for markedsføringstilladelsen. 
Hence the CHMP is of the opinion that a revised protocol should be submitted to the national competent authorities, for final agreement prior the start of the clinical trial, as a condition to the marketing authorisation.
Doseringen af Mifepristone Linepharma er ikke den samme som for referencelægemidlet Mifegyne. 
The posology of Mifepristone Linepharma is not the same as for the reference product Mifegyne.
• CHMP er af den opfattelse, at den maksimale dosis skal være 200 mg, og at dette skal angives klart i produktoplysningerne. 
• The CHMP is of the opinion that a dose higher than 200 mg should not be administered and that this should be clearly indicated in the Product Information.
Der blev ikke konstateret alvorlige uventede bivirkninger af den pågældende behandling. 
No serious unexpected events were related to the regimen studied.
Baseret på resultaterne af de to kliniske undersøgelser og under hensyntagen til, at Mifepristone Linepharma kun administreres en gang og som en enkelt dosis, var CHMP af den opfattelse, at den højere Cmax ikke ville indvirke på sikkerheden og virkningen af Mifepristone Linepharma. 
Based on the results of the 2 clinical studies and taking into consideration that Mifepristone Linepharma is only given once and as a single dose, the CHMP was of the opinion that the higher Cmax would not affect safety or efficacy of Mifepristone Linepharma.
Kvinderne havde ret til at blive behandlet med 200 mg Mifepristone Linepharma oralt efterfulgt af 800 μg misoprostol ved graviditet på 63 dages amenorré eller derunder. 
Women were entitled to be treated with 200 mg of Mifepristone Linepharma orally followed by 800 μg of misoprostol if their pregnancy age was 63 days of amenorrhea or less.
I lyset af ovenstående mener CHMP, at Mifepristone Linepharmas overordnede virkning og sikkerhedsprofil er blevet tilstrækkelig påvist i de fremlagte undersøgelser og har derfor konkluderet, at benefit/risk-forholdet for Mifepristone Linepharma til den anvendte indikation "medicinsk afbrydelse af intrauterin graviditet under udvikling, i sekventiel anvendelse med en prostaglandinanalog, op til 63 dage med amenorré" er gunstigt. 
Based on the above, the CHMP considers that the overall efficacy and safety profile of the Mifepristone Linepharma has been sufficiently proven by the studies presented and therefore concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indication “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea” is favourable.
I forhold til Mifegyne, der kan administreres ved en høj dosis på 600 mg eller en lavere dosis på 200 mg, er det kun den lavere dosis på 200 mg, der er godkendt for Mifepristone Linepharma. 
Compared to Mifegyne, which could be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg is approved for Mifepristone Linepharma.
Indikationen for Mifepristone Linepharma, der er blevet godkendt gennem den første gensidige anerkendelsesprocedure, er: "medicinsk afbrydelse af intrauterin graviditet under udvikling, i sekventiel anvendelse med en prostaglandinanalog, op til 63 dage med amenorré". 
The approved indication for Mifepristone Linepharma through the initial Mutual Recognition Procedure is “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea”.
- Organisationen Gynuity Health Projects udførte en undersøgelse om gennemførelse af god klinisk praksis i Mexico, der omfattede 1 000 kvinder (åben, ikke-komparativ, prospektiv multi-siteundersøgelse af administrationen af en dosis på 200 mg mifepriston efterfulgt 24 til 48 timer senere af 800 mcg oralt misoprostol til afbrydelse af graviditet, op til 63 dage). 
- The organisation Gynuity Health Projects performed a GCP-compliant study in Mexico in 1000 women (open-label, non-comparative, prospective multi-site study of mifepristone 200 mg followed 24-48 hours later by buccal misoprostol 800 mcg for termination of pregnancy through 63 days).
Baggrunden for dette alternativ var, at 200 mg mifepriston i kombination med oralt misoprostol indebar en højere risiko for fortsættelse af graviditet, hvorimod en lang række undersøgelser havde vist, at 1 mg gemeprost per vaginum havde en stærk prostaglandinindvirkning, også i kombination med en lavere dosis mifepriston. 
The reason for this alternative was the fact that the combination of 200 mg mifepristone with oral misoprostol was associated with a potentially higher risk of continuing pregnancy, whereas 1mg gemeprost vaginally had been demonstrated in many studies to provide a strong prostaglandin action also in combination with a lower dose of mifepristone.
CHMP har derfor anbefalet, at der udstedes en markedsføringstilladelse, såfremt den anbefalede betingelse for sikker og virkningsfuld brug af lægemidlet i bilag IV opfyldes, for hvilke ændringerne i de relevante punkter i produktresuméet og indlægssedlen fremgår af bilag III for Mifepristone Linepharma og relaterede navne (se bilag I). 
• Therefore the Committee concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indications is favourable, the CHMP has recommended the granting of the marketing authorisation subject to a recommended condition with regard to the safe and effective use of the medicinal product as set out in Annex IV and for which the amended sections of the summary of product characteristics and package leaflet are set out in Annex III for Mifepristone Linepharma and associated names (see Annex I).
I lyset af ovenstående og den lidt højere Cmax er CHMP af den opfattelse, at den maksimale dosis skal være 200 mg Mifepristone Linepharma, og at dette skal angives klart i produktoplysningerne, og at der skal udføres et prospektivt observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet. 
Based on the above, in view of the slightly increased Cmax, the CHMP is of the opinion that a higher dose than 200mg of Mifepristone Linepharma should not be administered and that this should be clearly indicated in the Product Information and a prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed.
Indehaveren af markedsføringstilladelsen fremsendte synopsen og et sammendrag af denne undersøgelse. 
The MAH provided the synopsis and abstract of this study.
I forhold til Mifegyne, der kan administreres ved en høj dosis på 600 mg eller en lavere dosis på 200 mg, er det kun den lavere dosis på 200 mg, der blev godkendt for Mifepristone Linepharma i forbindelse med den første bølge af godkendelser under den gensidige anerkendelsesprocedure, hvilket også er indstillingen under den nuværende gensidige anerkendelsesprocedure for gentagen anvendelse. 
Compared to Mifegyne, which can be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg was approved for Mifepristone Linepharma through the first wave of the Mutual Recognition Procedure and was also being proposed in the current MRP repeated procedure.
Da Mifepristone Linepharma kun administreres en gang og som en enkelt dosis på 200 mg, er det CHMP's opfattelse, at de foreliggende kliniske data understøtter, at den lidt højere Cmax ikke vil indvirke på sikkerheden og virkningen af Mifepristone Linepharma. 
Taking into consideration that Mifepristone Linepharma is only given once and as a single dose of 200mg, the CHMP is of the opinion that the provided clinical data supports that the slightly higher Cmax would not affect efficacy and safety of Mifepristone Linepharma.
Der skal udføres et prospektivt observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet som en betingelse for markedsføringstilladelsen. 
A prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed as a condition to the marketing authorisation.
CHMP er imidlertid af den opfattelse, at den maksimale dosis skal være 200 mg Mifepristone Linepharma, og at dette skal angives klart i produktoplysningerne. 
The CHMP considers however that a higher dose than 200mg of Mifepristone Linepharma should not be administered and that this should be clearly indicated in the Product Information.
Doseringen er ikke den samme som for referencelægemidlet Mifegyne. 
The posology is different to the reference product Mifegyne.
Der skal desuden udføres et prospektivt observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet. 
In addition, a prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed;
I det nuværende produktresumé for mifepriston-referencelægemidlet anbefales en dosis på 600 mg mifepriston efterfulgt 36 til 48 timer senere af misoprostol 400 µg oralt eller gemeprost 1 mg vaginalt til afbrydelse af graviditet, op til 49 dage med amenorré. 
The current SmPC for the reference product mifepristone recommends mifepristone at the dose of 600 mg followed 36 to 48 hours later by 400 µg misoprostol orally or gemeprost 1 mg per vaginam for pregnancy termination up to 49 days of amenorrhea.
På tidspunktet for indbringelsesproceduren for CMDh gennemgik CHMP som foreslået af indehaveren af markedsføringstilladelsen under indbringelsesproceduren protokollen for det prospektive observationsstudie for at evaluere ordinationsanbefalingerne for Mifepristone Linepharma til afbrydelse af tidlig graviditet. 
As proposed by the MAH at the time of the CMDh referral procedure, the protocol for the prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination was reviewed by the CHMP during the referral procedure.
Alternativt kan 200 mg mifepriston også bruges som en enkelt oral dosis, hvis denne dosis efterfølges 36 til 48 timer senere af administration af prostaglandinanalogen gemeprost 1 mg vaginalt. 
An alternative of 200 mg of mifepristone was also approved to be used as a single dose, provided that this dose is followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Indehaveren af markedsføringstilladelsen har fremlagt en indledende undersøgelse vedrørende 1 343 kvinder. 
A preliminary publication in 1343 women has been provided by the MAH.
Den godkendte dosering er 200 mg mifepriston som en enkelt oral dosis efterfulgt 36 til 48 timer senere af administration af prostaglandinanalogen gemeprost 1 mg vaginalt. 
The approved posology is 200 mg of mifepristone in a single oral dose, followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam.
Følgende noteres: 
Whereas,
Det aktive stof i Pioglitazone ratiopharm GmbH, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner. 
The active substance in Pioglitazone ratiopharm GmbH, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Det betyder, at Pioglitazone ratiopharm GmbH er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU) kaldet Actos. 
This means that Pioglitazone ratiopharm GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
CHMP konkluderede, at det i overensstemmelse med EU's krav var blevet påvist, at Pioglitazone ratiopharm GmbH er af sammenlignelig kvalitet og er bioækvivalent med Actos. 
The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm GmbH had been shown to have comparable quality and to be bioequivalent to Actos.
På tidspunktet for tilbagetrækningen havde CHMP derfor afgivet en positiv udtalelse, hvori der anbefaledes udstedelse af markedsføringstilladelse for Pioglitazone ratiopharm GmbH til behandling af type 2-diabetes. 
Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratiopharm GmbH for the treatment of type 2 diabetes.
Den 3. februar 2012 meddelte ratiopharm GmbH officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Pioglitazone ratiopharm GmbH til behandling af type 2-diabetes tilbage. 
On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratiopharm GmbH, for the treatment of type 2 diabetes.
Pioglitazone ratiopharm GmbH skulle have været anvendt til behandling af type 2-diabetes hos voksne, især overvægtige. 
Pioglitazone ratiopharm GmbH was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Pioglitazone ratiopharm GmbH blev udviklet som et ‘generisk lægemiddel'. 
Pioglitazone ratiopharm GmbH was developed as a ‘generic medicine'.
Pioglitazone ratiopharm GmbH er et lægemiddel, der indeholder det aktive stof pioglitazon. 
Pioglitazone ratiopharm GmbH is a medicine that contains the active substance pioglitazone.
Da Pioglitazone ratiopharm GmbH er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos. 
Because Pioglitazone ratiopharm GmbH is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Pioglitazone ratiopharm GmbH skulle også have været anvendt sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin. 
Pioglitazone ratiopharm GmbH was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Hvad er Pioglitazone ratiopharm GmbH? 
What is Pioglitazone ratiopharm GmbH?
Pioglitazone ratiopharm GmbH skulle have været anvendt alene til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet. 
Pioglitazone ratiopharm GmbH was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Pioglitazone ratiopharm GmbH skulle også have været anvendt i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene (‘tostofsbehandling'). 
Pioglitazone ratiopharm GmbH was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone.
Hvad forventedes Pioglitazone ratiopharm GmbH anvendt til? 
What was Pioglitazone ratiopharm GmbH expected to be used for?
Hvordan forventedes Pioglitazone ratiopharm GmbH at virke? 
How is Pioglitazone ratiopharm GmbH expected to work?
Den endelige udtalelse blev overdraget til Europa-Kommissionen, som vedtog en retligt bindende afgørelse den 19. november 2014. 
The final opinion was sent to the European Commission, which issued a legally binding decision on 19 November 2014.
Mere om lukningen af fremstillingsstedet 
More about the closure of the manufacturing site
MACI har siden 2013 været markedsført i Danmark, Grækenland og Det Forenede Kongerige. 
Since 2013 MACI has been marketed in Denmark, Greece and the UK.
Denne type lægemiddel indeholder celler eller væv, der er manipuleret, så de kan bruges til at reparere, gendanne 
This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate
MACI har været markedsført siden 1998 i de enkelte EU-lande gennem nationale procedurer. 
MACI was on the market since 1998 in individual EU countries according to national procedures.
Lukning af EU-fremstillingsstedet for MACI 
Closure of EU manufacturing site for MACI
Artikel 118 i direktiv 2001/83/EF, der fastslår, at en markedsføringstilladelse skal suspenderes, hvis et eller flere af kravene i artikel 41 (såsom kravet om et fremstillingssted) ikke længere er opfyldt. 
Article 118 of Directive 2001/83/EC, which specifies that a marketing authorisation must be suspended in case any one of the requirements laid down in Article 41 (such as the need for a manufacturing site) is no longer met.
• Nye patienter bør behandles med et passende alternativ, og lægerne bør ikke bestille nye 
• New patients should be treated with a suitable alternative and surgeons should not order new
• Læger og hospitaler, som har anvendt MACI, blev i juni 2014 underrettet om den planlagte lukning af EU-fremstillingsstedet for MACI. 
• Surgeons and hospitals that have been using MACI were informed in June 2014 of the planned closure of the EU manufacturing site for MACI.