natgillin/translations-raw huggingface dataset:
Fortæl det til lægen, hvis du tager noget af den medicin, som er nævnt her. 
Please inform your doctor if you are taking medicines according to the following list.
Symptomerne på overaktiv blære kan komme igen eller blive forværret, når du holder op med at tage TOVIAZ. 
Do not stop taking TOVIAZ without talking to your doctor, as your symptoms of overactive bladder may come back again or become worse once you stop taking TOVIAZ.
• hvis du har nyreproblemer, eller moderate til alvorlige leverproblemer, og tager medicin, som indeholder nogen af følgende aktive stoffer: itraconazol eller ketoconazol (anvendes til behandling af svampeinfektioner), ritonavir, atazanavir, indinavir, saquinavir eller nelfinavir 
- if you have kidney problems or moderate to severe liver problems and are taking medicines containing any of the following active substances: itraconazole or ketoconazole (used to treat fungal infections), ritonavir, atazanavir, indinavir, saquinavir or nelfinavir (antiviral medicine for treating HIV), clarithromycin or telithromycin (used to treat bacterial infections) and nefazodone (used to treat depression)
Fesoterodin hæmmer ikke P-pillers undertrykkelse af ovulation. 
Fesoterodine does not impair the suppression of ovulation by oral hormonal contraception.
Dette gør sig især gældende ved brug af potente CYP3A4-hæmmere (se pkt. 
This especially holds true when taking potent CYP3A4 inhibitors (see sections 4.2, 4.5 and 5.1).
Sådan skal du tage TOVIAZ 
How to take TOVIAZ
Mave-tarm-kanalen Mundtørhed Abdominalsmerter; diaré; dyspepsi; forstoppelse; kvalme 
Dry mouth Abdominal pain; Diarrhoea;
Meget almindelige (forekommer hos flere end 1 ud af 10 personer) Mundtørhed. 
Very common (may affect more than 1 in 10 people) You may get a dry mouth.
Hver tablet indeholder 4 mg fesoterodinfumarat 
Each tablet contains 4 mg fesoterodine fumarate
• tørhed i halsen 
• dry throat
Blisteretiket 4 mg 
Blister label 4 mg
4.3) - gastrointestinale obstruktive lidelser (f.eks. pylorusstenose) - gastro-øsofageal refluks og/eller samtidig indtagelse lægemidler (som orale bisfosfonater), som kan forårsage eller forværre oesophagitis - reduceret gastrointestinal motilitet 
- Clinically significant bladder outflow obstruction at risk of urinary retention (e.g. clinically significant prostate enlargement due to benign prostatic hyperplasia, see section 4.3) - Gastrointestinal obstructive disorders (e.g. pyloric stenosis) - Gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as oral bisphosphonates) that can cause or exacerbate oesophagitis - Decreased gastrointestinal motility - Autonomic neuropathy - Controlled narrow-angle glaucoma
Samtidig brug af CYP3A4-induktorer (f.eks. carbamazepin, rifampicin, phenobarbital, phenytoin, perikon) frarådes (se pkt. 
Concomitant use with CYP3A4 inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) is not recommended (see section 4.4).
4.2, 4.3 og 5.2) - samtidig behandling med potent eller moderat CYP3A4-hæmmer (se pkt. 
- Hepatic impairment (see sections 4.2, 4.3 and 5.2) - Renal impairment (see sections 4.2, 4.3 and 5.2) - Concomitant administration of potent or moderate CYP3A4 inhibitors (see sections 4.2 and
EU/1/07/386/001 7 depottabletter EU/1/07/386/002 14 depottabletter EU/1/07/386/003 28 depottabletter EU/1/07/386/019 30 depottabletter EU/1/07/386/004 56 depottabletter EU/1/07/386/005 98 depottabletter EU/1/07/386/011 84 depottabletter EU/1/07/386/017 100 depottabletter 
EU/1/07/386/001 7 prolonged-release tablets EU/1/07/386/002 14 prolonged-release tablets EU/1/07/386/003 28 prolonged-release tablets EU/1/07/386/019 30 prolonged-release tablets EU/1/07/386/004 56 prolonged-release tablets EU/1/07/386/005 98 prolonged-release tablets EU/1/07/386/011 84 prolonged-release tablets EU/1/07/386/017 100 prolonged-release tablets
EU/1/07/386/006 7 depottabletter EU/1/07/386/007 14 depottabletter EU/1/07/386/008 28 depottabletter EU/1/07/386/020 30 depottabletter EU/1/07/386/009 56 depottabletter EU/1/07/386/010 98 depottabletter EU/1/07/386/012 84 depottabletter EU/1/07/386/018 100 depottabletter 
EU/1/07/386/006 7 prolonged-release tablets EU/1/07/386/007 14 prolonged-release tablets EU/1/07/386/008 28 prolonged-release tablets EU/1/07/386/020 30 prolonged-release tablets EU/1/07/386/009 56 prolonged-release tablets EU/1/07/386/010 98 prolonged-release tablets EU/1/07/386/012 84 prolonged-release tablets EU/1/07/386/018 100 prolonged-release tablets
Det er ukendt, om fesoterodin/metabolitter udskilles i modermælk. 
It is unknown whether fesoterodine/metabolites are excreted into human milk; therefore, breast-feeding is not recommended during treatment with TOVIAZ.
Hver tablet indeholder 8 mg fesoterodinfumarat 
Each tablet contains 8 mg fesoterodine fumarate
• du har langsomt hjerteslag (bradykardi) 
• increased heart beat (tachycardia)
Fund fra mus ved eksponeringer, der var ca. 5 til 19 gange højere end MRHD, viser en påvirkning af hunnens fertilitet. 
Findings in mice at exposures approximately 5 to 19 times those at the MRHD show an effect on female fertility, however, the clinical implications of these animal findings are not known (see section 5.3).
4.5 (4) Potente CYP3A4-hæmmere. 
See section 4.5 (4) Potent CYP3A4 inhibitors.
Blisteretiket 8 mg 
Blister label 8 mg
• besvær med at fordøje maden 
• trouble digesting food (dyspepsia)
TOVIAZ 4 mg tabletter EU/1/07/386/001-005 EU/1/07/386/011 
TOVIAZ 4 mg tablets EU/1/07/386/001-005 EU/1/07/386/011 EU/1/07/386/013-014
• udslæt 
• urticaria
Samtidig brug af fesoterodin og en stærk CYP3A4-induktor (dvs. carbamazepin, rifampicin, phenobarbital, phenytoin, prikbladet perikon) frarådes (se pkt. 
The concomitant use of fesoterodine with a potent CYP3A4 inducer (i.e. carbamazepine, rifampicin, phenobarbital, phenytoin, St John's Wort) is not recommended (see section 4.5).
Dette blev målt ved en plasmaeksponering, som var mindst 33 gange højere end plasmakoncentration hos hurtige CYP2D6-omsættere, og 21 gange højere end målt hos personer, som er langsomme CYP2D6-omsættere efter administration af fesoterodin 8 mg 1 gang dagligt. 
However in conscious dogs, the active metabolite had no effect on the QT interval and QTc interval at plasma exposures at least 33-fold higher than mean peak free plasma concentration in human subjects who are extensive metabolisers and 21-fold higher than measured in subjects who are poor CYP2D6 metabolisers after fesoterodine 8 mg once daily.
Følgende tabel angiver dosisrekommandationer for patienter med nedsat nyre- og leverfunktion, både med og uden samtidig behandling med potente CYP3A4-hæmmere (se pkt. 
The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of moderate and potent CYP3A4 inhibitors (see sections 4.3, 4.4, 4.5 and 5.2).
Det skal du vide, før du begynder at tage TOVIAZ Sådan skal du tage TOVIAZ Bivirkninger 
What is in this leaflet What TOVIAZ is and what it is used for What you need to know before you take TOVIAZ How to take TOVIAZ Possible side effects How to store TOVIAZ Contents of the pack and other information
Hver depottablet indeholder 8 mg fesoterodinfumarat, som svarer til 6,2 mg fesoterodin. 
Each prolonged-release tablet contains 8 mg fesoterodine fumarate, equivalent to 6.2 mg of fesoterodine.
Depottablet. 
Dyspepsia;
• hvis du ikke er i stand til at tømme blæren helt (urinretention) 
• not being able to control when you empty your bladder (called urgency incontinence)
Svimmelhed; hovedpine 
Dizziness; Headache
• smerter i halsen 
• pain in the stomach
Hver depottablet indeholder 4 mg fesoterodinfumarat, som svarer til 3,1 mg fesoterodin. 
Each prolonged-release tablet contains 4 mg fesoterodine fumarate, equivalent to 3.1 mg of fesoterodine.
Almindelige (forekommer hos mellem 1 og 10 ud af 100 personer) 
Uncommon (may affect up to 1 in 100 people)
TOVIAZ 4 mg depottabletter TOVIAZ 8 mg depottabletter 
TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets
• oppustethed (afgang af tarmluft) 
• wind (flatulence)
Alder og køn påvirker ikke fesoterodins farmakokinetik signifikant. 
The pharmacokinetics of fesoterodine are not significantly influenced by age and gender.
TOVIAZ udseende og pakningsstørrelser 
What TOVIAZ looks like and contents of the pack
EU/1/07/386/015 30 depottabletter EU/1/07/386/016 90 depottabletter 
EU/1/07/386/015 30 prolonged-release tablets EU/1/07/386/016 90 prolonged-release tablets
TOVIAZ 4 mg depottabletter fesoterodinfumarat 
TOVIAZ 4 mg prolonged-release tablets fesoterodine fumarate
8 mg-tabletterne er blå, ovale, bikonvekse, filmovertrukne og er på den ene side præget med bogstaverne ‘FT'. 
The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FT'.
Stærke CYP3A4-induktorer 
Potent CYP3A4 inducers
EU/1/07/386/013 30 depottabletter EU/1/07/386/014 90 depottabletter 
EU/1/07/386/013 30 prolonged-release tablets EU/1/07/386/014 90 prolonged-release tablets
TOVIAZ 8 mg depottabletter fesoterodinfumarat 
TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
- Medicin, der indeholder det aktive stof amantadin (der bruges til behandling af Parkinsons syge) - Visse typer medicin til at fremme fordøjelsen, lindre mavekramper eller -spasmer og til at forhindre køresyge, f.eks. medicin, der indeholder metoclopramid - Visse typer medicin til behandling af psykiske lidelser, f.eks. antidepressiva og neuroleptika. 
- certain medicines used to enhance gastrointestinal motility or to relieve stomach cramps or spasm and to prevent travel sickness like medicines containing metoclopramide.
4 mg-tabletterne er lyseblå, ovale, bikonvekse, filmovertrukne og er på den ene side præget med bogstaverne ‘FS'. 
The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FS'.
TOVIAZ 4 mg depottabletter er lyseblå, ovale, buede udad på begge sider, filmovertrukne og på den ene side præget med bogstaverne ‘FS'. 
TOVIAZ 4 mg prolonged-release tablets are light blue, oval, curved outwards on both sides, filmcoated tablets, and engraved on one side with the letters ‘FS'.
TOVIAZ 8 mg depottabletter er blå, ovale, buede udad på begge sider, filmovertrukne og på den ene side præget med bogstaverne ‘FT'. 
TOVIAZ 8 mg prolonged-release tablets are blue, oval, curved outwards on both sides, film-coated tablets, and engraved on one side with the letters ‘FT'.
TOVIAZ 8 mg tabletter En depottablet indeholder fesoterodinfumarat 8 mg svarende til 6,2 mg fesoterodin. 
Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of fesoterodine.
Hvis du har taget for meget TOVIAZ 
If you take more TOVIAZ than you should
Ubehag i maven; flatulens; gastroøsofageal refluks 
Flatulence, Gastroesophage al reflux
4.2 og 4.5) - samtidig behandling med potent CYP2D6-hæmmer (se pkt. 
- Concomitant administration of a potent CYP2D6 inhibitor (see sections 4.5 and 5.2).
Du må ikke tage TOVIAZ, hvis du ammer, da man ikke ved, om fesoterodin udskilles i modermælken hos mennesker. 
It is not known whether fesoterodine is excreted into human milk; therefore, do not breast-feed during treatment with TOVIAZ.
TOVIAZ 4 mg tabletter En depottablet indeholder fesoterodinfumarat 4 mg svarende til 3,1 mg fesoterodin. 
Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of fesoterodine.
• hvis du har svært ved at tømme blæren helt (f.eks. på grund af forstørret blærehalskirtel) 
• having to empty your bladder more often than usual (called increased urinary frequency)
• Ventrikelretention 
• Gastric retention
Hos patienter med svært nedsat nyrefunktion (GFR < 30 ml/min.) 
In patients with severe renal impairment (GFR < 30 ml/min), Cmax and AUC are increased 2.0 and 2.3-fold, respectively.
Yderpakning 8 mg 
Outer carton 8 mg
Svage CYP3A4-hæmmere 
Weak CYP3A4 inhibitors
Yderpakning 4 mg 
Outer carton 4 mg
TOVIAZ 4 mg depottabletter TOVIAZ 8 mg depottabletter fesoterodinfumarat 
TOVIAZ 4 mg prolonged-release tablets TOVIAZ 8 mg prolonged-release tablets fesoterodine fumarate
Dosisøgning 
Posology
Smerter i hals og svælg; hoste; tørhed i næsen 
Pharyngolaryng eal pain; Cough; Nasal dryness
- Lægen har ordineret TOVIAZ til dig personligt. 
- This medicine has been prescribed for you only.
Potente CYP3A4-hæmmere 
Potent CYP3A4 inhibitors
• hvis du er allergisk over for fesoterodin, over for jordnødder eller soja eller et af de øvrige indholdsstoffer i TOVIAZ (angivet i afsnit 6) (se afsnit 2 ”TOVIAZ indeholder lactose og sojaolie”) 
Do not take TOVIAZ: - if you are allergic to fesoterodine or to peanut or soya or to any of the other ingredients of
CAP = centralt godkendt produkt. 
CAP = centrally authorised product.
1 000 EUR 
EUR thousand
Disse typer behandling er fortsat et prioriteret indsatsområde for sektoren for smådyrs sundhed. 
These types of treatment remain a priority area for the companion-animal health sector.
Indsendte Positive udtalelser Negative udtalelser Tilbagetrækninger Kommissionens afgørelser 
Submitted Positive opinions Negative opinions Withdrawals Commission decisions
Der var et fald på 5 % til 91 ansøgninger om indledende vurdering af lægemidler. 
There was a 5% decrease to 91 applications for initial evaluation of medicines.
Heraf drejede 73 ansøgninger sig om aktivt stof, svarende til en stigning på 16 % sammenholdt med 2009. 
These relate to 73 applications by active substance, representing an increase of 16% compared to 2009.
Otte anmodninger drejede sig om mindre udbredte sygdomme/mindre arter (MUMS)/begrænsede markeder. 
Eight requests were for minor use/minor species (MUMS)/limited markets.
Det udvindes af mælk fra kaniner, der har fået tilført et gen (DNA), der sætter dem i stand til at producere humant protein i deres mælk. 
It is extracted from the milk of rabbits that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Udviklingen i EMA's budget 
EMA budget evolution
Disse fejl, der primært opstod som følge af den hurtige diversificering af agenturets aktiviteter, bidrog til EuropaParlamentets afstemning om at udsætte dechargen for 2009-budgettet - hvilket er første gang, dette er sket siden agenturets oprettelse i 1995. 
These errors, which occurred primarily due to the rapid diversification of the Agency's activities, contributed to the European Parliament's vote to postpone the discharge for the 2009 budget - the first time this has happened since the Agency was established, in 1995.
Der blev i begyndelsen af året offentliggjort en rapport om evalueringen af agenturet, udført af Ernst & Young. 
A report on the evaluation of the Agency, carried out by Ernst & Young, was published at the beginning of the year.
Det er en glæde for mig at kunne meddele, at agenturet nu har taget hånd om alle de opståede fejl, og vi forventer, at der kan meddeles decharge for budgettet i den nærmeste fremtid. 
I am pleased to report that the Agency has now addressed all of the errors, and we expect a successful discharge of the budget in the near future.
• Ny lovgivning om lægemiddelovervågning vedtages af Europa-Parlamentet. 
• New pharmacovigilance legislation is adopted by European Parliament.
Vi arbejdede i løbet af hele året på at tilrettelægge en ny femårsstrategi for agenturet - “Køreplan frem til 2015”, der blev vedtaget af bestyrelsen og offentliggjort i december - der skulle være med til at sikre, at agenturet trimmes til at takle udfordringerne fremadrettet. 
Throughout the year, we worked to develop a new five-year strategy for the Agency - the 'Road map to 2015', adopted by the Management Board and published in December - which should help to ensure the Agency is fit to tackle the challenges ahead.
Tilbagekaldelser Klasse 1 Klasse 2 Klasse 3 
Quality defects reported Recalls Class 1 Class 2 Class 3
I perioden op til hans afgang blev der sat mange kræfter ind på at evaluere, hvor agenturet står i øjeblikket, og forberede det på fremtiden. 
In the lead-up to his departure, much effort was put into evaluating where the Agency currently stands and making preparations for the future.
Det samlede antal inspektioner var 20 % over prognoserne, primært som følge af en uventet stigning i antallet af ønskede inspektioner vedrørende god klinisk praksis (GCP). 
The total number of inspections was 20% above the forecast, mainly due to an unexpected increase in the number of good-clinical-practice (GCP) inspections requested.
Fordelingen af typer ændringer skiftede markant over hele året som en konsekvens af den nye lovgivning om ændringer. 
The distribution of types of variations changed significantly throughout the year as a consequence of the new legislation on variations.
I oktober offentliggjorde vi nye regler for interessekonflikter, der forholdt sig til vores behov for at få adgang til Europas bedste videnskabelige eksperter, samtidig med at vi sikrede, at de ikke har nogen økonomiske eller andre interesser, der kunne påvirke deres upartiskhed. 
In October, we published new rules on conflicts of interests, addressing our need to access Europe's best scientific experts while ensuring they have no financial or other interests that could affect their impartiality.
Et omfattende udbrud af denne bakteriesygdom, der er den agens, der fremkalder Q-feber hos mennesker, opstod i Nederlandene i 2009. 
An extensive outbreak of this bacterial disease, which is the causative agent of Q fever in man, occurred in the Netherlands in 2009.
Gebyrer og andre indtægter 
Fees and other income
Den administrerende direktørs kontor 
Office of the Executive Director
CVMP fandt det derfor passende at anbefale, at produktet tillades under ekstraordinære omstændigheder på basis af en positiv benefit/risk-balance, mens der gennemføres yderligere undersøgelser for mere præcist at få fastslået effekten hos geder. 
The CVMP therefore considered it appropriate to recommend that the product be authorised under exceptional circumstances on the basis of a positive benefit-risk balance while further studies are carried out to determine more precisely the efficacy in goats.
Produktet er af stor interesse for folkesundheden i lyset af manglen på tilladt medicin til behandling af denne sygdom. 
The product is of major public-health interest in light of the shortage of the authorised medicine for the treatment of this disease.
• EMA lancerer sit nye websted. 
• EMA launches its new website.
Formålet hermed er at sikre, at overvågning og effektiv risikostyring efter godkendelse anvendes regelmæssigt på veterinærlægemidler i hele EU. 
It aims at ensuring that post-authorisation monitoring and effective risk-management are continuously applied to veterinary medicines throughout the EU.
Og i november tog vi et stort skridt frem i forhold til gennemsigtighed og offentliggjorde en politik for aktindsigt i dokumenter, der giver offentligheden bredere adgang end nogensinde før til de dokumenter, som vi er i besiddelse af, både vedrørende humanmedicinske og veterinærmedicinske lægemidler. 
And in November, we took a major step forward in transparency, publishing a policy on access to documents that gives wider public access than ever before to the documents we hold concerning both human and veterinary medicines.
Anvendelsen af veterinærlægemidler i fødevareproducerende dyr kan føre til forekomsten af restkoncentrationer i levnedsmidler som følge af behandlede dyr. 
The use of veterinary medicines in food-producing animals may result in the presence of residues in foodstuffs obtained from treated animals.
Disse vacciner blev godkendt under ekstraordinære omstændigheder for at beskytte kvæg og får mod kliniske tegn, og for at reducere eller forebygge transmission af serotype 1, 2, 4 og 8 af den stærkt variable ”blue tongue”-virus. 
These vaccines were authorised under exceptional circumstances to protect cattle and sheep against clinical signs, and to reduce or prevent transmission of serotypes 1, 2, 4 and 8 of the highly variable bluetongue virus.
Thomas forlod agenturet i december efter ti succesrige år ved roret, hvor han stod i spidsen for agenturets fantastiske vækst, ikke blot rent størrelsesmæssigt, men også med hensyn til omfanget af agenturets aktiviteter. 
Thomas left the Agency in December after ten successful years at its helm, overseeing the phenomenal growth of the Agency, not only in terms of sheer size, but also in the range of its activities.
Generelt EU-bidrag 
General EU contribution
Når vi skuer frem mod 2011, er jeg sikker på, at agenturet vil påtage sig nye udfordringer, herunder udnævnelsen af en ny administrerende direktør og gennemførelsen af nye lovgivningskrav, samtidig med at det opfylder sin kernevirksomhed, nemlig at beskytte folke- og dyresundheden i EU. 
As we look forward to 2011, I am sure that the Agency will take new challenges in its stride, including the appointment of a new Executive Director and the implementation of new legislative requirements, while continuing to fulfil its core business of protecting public and animal health in the European Union.
Næsten halvdelen (44) af alle ansøgninger drejede sig om bioækvivalente eller generiske lægemidler og hybride anvendelser eller anvendelser med informeret samtykke. 
Almost half (44) of all applications were for biosimilar or generic medicines and hybrid or informedconsent applications.
• EMA styrker reglerne om interessekonflikter for dets videnskabelige eksperter. 
• EMA strengthens rules on conflicts of interests for its scientific experts.
Med en stigende arbejdsbyrde på næsten alle områder var der tale om endnu et travlt år for agenturet. 
With increases in workload in almost all areas, this was another busy year for the Agency.
Lægemidler til sjældne sygdomme er beregnet til diagnosticering, forebyggelse eller behandling af livstruende eller kronisk invaliderende lidelser, der ikke berører mere end fem ud af 10 000 personer i EU, eller hvor der af økonomiske årsager ikke ville blive udviklet sådanne lægemidler uden incitamenter. 
Orphan medicines are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the European Union, or where for economic reasons such medicines would not be developed without incentives.
Vi gennemførte en række foranstaltninger, der skal styrke agenturets indkøbsprocedurer i 2010, og som fulgte i kølvandet af visse tekniske fejl, der var opstået over de foregående fem år. 
We implemented a series of measures to strengthen the Agency's procurement procedures in 2010, following some technical errors that had occurred over the previous few years.
Agenturet tilvejebringer videnskabelig rådgivning og protokolbistand til sponsorer i lægemidlers forsknings- og udviklingsfase. 
The Agency provides scientific advice and protocol assistance to sponsors during the phase of research and development of medicinal products.
2010 var året, hvor vi i Det Europæiske Lægemiddelagentur (EMA) oplevede mange forandringer, hvor den mest fremtrædende var Thomas Lönngrens afgang, agenturets administrerende direktør. 
The year 2010 saw many changes at the European Medicines Agency, the most poignant of which was the departure of the Agency's Executive Director, Thomas Lönngren.
Indbringelsesprocedurer anvendes til at løse uoverensstemmelser og håndtere bekymringer blandt medlemsstaterne. 
Referral procedures are used to resolve disagreements and address concerns among Member States.
Tilladelse på EUniveau gør vacciner umiddelbart tilgængelige for brug som led i national og transnationale kampagner for sygdomskontrol mod denne stærkt virulente og smitsomme sygdom for husdyrbestande. 
Authorisation at EU level makes vaccines immediately available for use as part of national and transnational diseasecontrol campaigns against this highly virulent and contagious disease of domestic livestock.
Af de modtagne ansøgninger vedrørte de 46 nye lægemidler, heraf 12 udpegede lægemidler til sjældne sygdomme. 
Of the applications received, 46 related to new medicines, 12 of which were designated orphan medicines.
Ansøgninger om maksimalgrænseværdier for restkoncentrationer (MRL) 
Applications for maximum residue limits (MRLs)