natgillin/translations-raw huggingface dataset:
Hos patienter, der ikke er helt ophelede inden for dette tidsrum, bør medicineringen fortsætte med samme dosis i endnu to uger. 
In patients not fully healed within this time, the medication should be continued at the same dose for another two weeks.
Farmakodynamiske egenskaber 
Pharmacodynamic Properties
mavesmerter, forstoppelse, opkastning, flatulens og dyspepsi. 
Gastrointestinal nausea, diarrhoea, stomach ache, constipation, vomiting, flatulence and dyspepsia.
• Behandling af reflux øsofagitis. 
• Treatment of reflux oesophagitis.
Lever og nyrer 
Liver and kidneys
30 mg: Ugennemsigtig, hvid hård gelatinekapsel, indeholdende piller med enterisk belægning. 
Opaque, white hard gelatine capsule, containing pellets with enteric coating.
Lægemidler, der hæmmer CYP3A4, såsom ketoconazol, itraconazol, proteasehæmmere, makrolider etc., kan markant øge plasmakoncentrationerne af lansoprazol. 
itraconazole, protease inhibitors, macrolides etc may markedly increase the plasma concentrations of lansoprazole.
Emballage (art og indhold) 
Nature and Contents of Container
Derudover for Lansoprazol 15 mg: 
Lansoprazole 15 mg:
Lægemidler, der hæmmer CYP3A4 
Drugs which inhibits CYP3A4
15 mg: Ugennemsigtig, gul hård gelatinekapsel, indeholdende piller med enterisk belægning. 
Opaque, yellow hard gelatine capsule, containing pellets with enteric coating.
Tredobbelte terapier med en protonpumpehæmmer, clarithromycin og enten amoxicillin eller metronidazol er den mest udbredte behandling for Helicobacter pylori-infektion. 
clarithromycin and either amoxycillin or metronidazole are the most widely accepted treatment for
ATPase i mavens parietalceller. 
ATPase of the parietal cells in the stomach.
Behandling af reflux øsofagitis: 
Treatment of reflux oesophagitis:
b) clarithromycin 250 mg to gange daglig + metronidazol 400-500 mg to gange daglig. 
a) amoxicillin 1 g twice daily + clarithromycin 500 mg twice daily, b) clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily, c) amoxicillin 1 g twice daily + metronidazole 400-500 mg twice daily.
bør disse patienter ikke behandles med lansoprazol (se pkt. 
Due to the lack of data in patients with severely impaired hepatic function, these patients should not be treated with lansoprazole (see section 4.4 “Special warnings and precautions for use”).
Den anbefalede dosis er 30 mg én gang daglig i 2 uger. 
The recommended dose is 30 mg once daily for 4 weeks.
Profylakse mod reflux øsofagitis: 
Prophylaxis of reflux oesophagitis:
INDEHAVER AF MARKEDFØRINGSTILLADELSEN [Udfyldes nationalt] 
MARKETING AUTHORISATION HOLDER [To be completed nationally]
Daglig doser på op til 180 mg lansoprazol er imidlertid blevet givet under afprøvninger uden signifikante bivirkninger. 
mg of lansoprazole have been administered in trials without significant undesirable effects.
Lansoprazol er en specifik hæmmer af parietalcellens protonpumpe. 
Effect on gastric acid secretion: Lansoprazole is a specific inhibitor of the parietal cell proton pump.
Ud fra følgende betragtninger: hensigten med henvisningen var at opnå enighed om et produktresumé med hensyn til doseringen i eradikationsbehandlingen for Helicobacter pylori; det af ansøgeren foreslåede produktresumé er blevet vurderet på grundlag af den forelagte dokumentation og den faglige drøftelse i udvalget anbefaler CHMP, at der udstedes markedsføringstilladelser med ændringer af produktresuméet for 
The Summary of Products Characteristic proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee.
Dosering og indgivelsesmåde 
Posology and Method of Administration
Det er påvist, at der ved en kombination af lansoprazol med antibiotika enten i en dobbelt eller tredobbelt behandling kan opnås en eradikationsrate for H. pylori på mellem 89 og 90 %. 
H. pylori eradication rate of between 80 and 90%.
Uforligeligheder 
Investigations
men hos patienter, de ikke er helt ophelede inden for dette tidsrum, bør medicineringen fortættes med samme dosis i endnu 4 uger. 
The ulcer usually heals within 4 weeks, but in patients not fully healed within this time, the medication should be continued at the same dose for another 4 weeks.
Styrke 
Holder
Fortegnelse over hjælpestoffer Sukkerkugler (sukrose og majstivelse) 
Sugar spheres (sucrose and maize starch) Sodium laurilsulphate Meglumine
30 mg lansoprazol 2 gange daglig i én uge i kombination med én af følgende tre kombinationer: a) amoxicillin 1 g to gange daglig + clarithromycin 500 mg to gange daglig. 
30 mg lansoprazole 2 times daily for one week in combination with one of the following three combinations:
4.8 Bivirkninger 
Undesirable Effects
Meglumin 
leucopenia.
Der henvises til pkt. 
Please refer to section 4.8.
Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, ansøgere, indehavere af markedsføringstilladelser i medlemsstaterne 
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, and marketing authorisation holders in the Member States
Nebido parenteral anvendelse 
Nebido parenteral use
KG Ringener Str. 45 
Ringener Str. 45
79111 Freiburg Germany 
79111 Freiburg
15125 Marousi 
15125 Marousi Greece
MSD Sharp&Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1 
Germany MSD Sharp&Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1
15341 Ag. Paraskevi 
15341 Ag. Paraskevi Greece
Kapsel, blød Oral anvendelse 
capsule, soft oral use
85540 Haar Germany 
85540 Haar
33611 Bielefeld Germany 
33611 Bielefeld
Lilly Deutschland GmbH Teichweg 3 
Germany Lilly Deutschland GmbH Teichweg 3
Axxeron transdermal spray, opløsning 
Axxeron transdermal spray, solution
Grækenland Bayer Ellas ABEE Sorou 18-20 
Bayer Ellas ABEE Sorou 18-20
Eifelfango ChemischPharmazeutische Wrke GmbH&Co. 
Germany Eifelfango ChemischPharmazeutische Wrke GmbH&Co.
Grækenland Ferring Ellas Farmakeytiki MEPE 
Ferring Ellas Farmakeytiki MEPE
Ferring Arzneimittel GmbH Fabrikstr.7 
Germany Ferring Arzneimittel GmbH Fabrikstr.7
1831 Machelen Belgium testosterone undecylate Nebido 
1831 Machelen Belgium testosterone undecylate
Dr. August Wolff GmbH&Co. 
Germany Dr. August Wolff GmbH&Co.
Storbritannien Merck Sharp & Dohme Limited 
Merck Sharp & Dohme Limited
Pierre Faber Pharma GmbH Jechtlinger Str. 13 
Germany Pierre Faber Pharma GmbH Jechtlinger Str. 13
Strawberry Hill, Newbury RG14 1JA 
Bayer House Strawberry Hill, Newbury RG14 1JA
Italy testosterone propionate TESTOVIS 
Italy testosterone propionate
Germany testosteron undecanoate Nebido 
Germany testosterone undecanoate Nebido
Storbritannien Alliance Pharmaceuticals Limited 
Alliance Pharmaceuticals Limited
Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB 
Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom testosterone enantate
Jenapharm GmbH&CO. 
Germany Jenapharm GmbH&CO.
Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate TESTO ENANT 
Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate
Greece testosterone enantate Testosterone Enenthate/Norma 
Testosterone Enenthate/Norma
28029 Madrid Spain testosterone propionate TESTEX 
28029 Madrid Spain testosterone propionate
GEYMONAT S.P.A., Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate TESTO ENANT 
GEYMONAT S.P.A., Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate
Grækenland Pierre Fabre Farmaka AE l. Mesogion 350 
Pierre Fabre Farmaka AE l. Mesogion 350
22,5 mg/patch plaster 
22,5 mg/patch patch
Storbritannien Ferring Pharmaceuticals Limited 
Ferring Pharmaceuticals Limited
BAYER SANTE 220, avenue de la Recherche 59120 Loos France 
BAYER SANTE 220, avenue de la Recherche, 59120 Loos France testosterone enantate
PIERRE FABRE IBERICA S.A. Ramón Trías Fargas, 7-11 08005 Barcelona Spain 
Ramón Trías Fargas, 7-11 08005 Barcelona Spain
Germany testosterone enantate Testosteron-Depot 250mg Eifelfango 
Testosteron-Depot 250mg Eifelfango
35396 Gießen Germany 
35396 Gießen
GALENpharm GmbH Wittland13 
Germany GALENpharm GmbH Wittland13
Viale Certosa, 130 20156 Milano Italy testosterone enanthate TESTOVIRON 
Viale Certosa, 130 20156 Milano Italy testosterone enanthate
Bulgarien Ferring GmbH Wittland 11 + Kiel D-24109 
Ferring GmbH Wittland 11 + Kiel D-24109
BAYER SANTE 220, avenue de la Recherche, 59120 Loos France testosterone enantate ANDROTARDYL 250 mg/1 ml, solution injectable intramusculaire 
BAYER SANTE 220, avenue de la Recherche 59120 Loos France testosterone undecanoate NEBIDO 1000 mg/4 ml, solution injectable
Czech Republic estradiol/testosterone FOLIVIRIN 
Czech Republic estradiol/testosterone
30 mg/patch Plaster 
30 mg/patch patch
Bayer Portugal, S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal testosterone enantate Testoviron Depot 
Bayer Portugal, S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal testosterone enantate
Slovenien Laboratoires BESINS INTERNATIONAL 
Sweden Laboratoires Besins International
Germany testosterone enantate Testoviron-Depot-250 250 mg/ml 
Testoviron-Depot-250 250 mg/ml
15 mg/patch plaster 
15 mg/patch patch
5340 BH Oss The Netherlands 
5340 BH Oss
Rotexmedica GmbH Arzneimittelwerk Bunsenstr.4 
Germany Rotexmedica GmbH Arzneimittelwerk
Via Vitorchiano 151 00189 Roma Italy 
Via Vitorchiano 151 00189 Roma Italy testosterone undecanoate ANDRIOL
Kutanopløsning Kutan og transdermal formuleringer 
Axiron cutaneous solution cutaneous and transdermal preparations
Storbritannien Laboratoires Besins International 
Germany Laboratoires Besins international
United Kingdom testosterone enantate Testosterone Enantate Ampoules 
Testosterone Enantate Ampoules
Storbritannien DHP Healthcare Limited 26 Pickering Street 
DHP Healthcare Limited 26 Pickering Street Maidstone, Kent ME15 9RS
Slovenien Ferring GmbH Wittland 11 
Ferring GmbH Wittland 11
Organon (Ireland) Limited PO Box 2857, Drynam Road, Swords Co. Dublin Ireland 
Organon (Ireland) Limited PO Box 2857, Drynam Road, Swords Co. Dublin Ireland testosterone undecanoate Restandol Testocaps 40 mg capsules, soft oral use
Germany testosterone enantate Testosteron-Depot Jenapharm 
Testosteron-Depot Jenapharm
Kutanopløsning Kutan anvendelse 
Axiron cutaneous solution
Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom 
Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom testosterone undecanoate Restandol 40mg capsule oral use
Bulgarien Bayer Pharma AG Müllerstraße 178 
Lithuania Bayer Pharma AG Mullerstrasse 178
Bayer Austria GmbH Herbststrasse 6-10 1160 Wien Austria testosterone undecanoat Nebido 1000 mg/4 ml Injektionslösung 
Bayer Austria GmbH Herbststrasse 6-10 1160 Wien Austria testosterone undecanoat
Czech Republic testosterone enantane Testosteronum prolongatum Jelfa 
Testosteronum prolongatum Jelfa
BAYER S.P.A., Viale Certosa, 130 20156 Milano Italy 
BAYER S.P.A., Viale Certosa, 130 20156 Milano Italy testosterone undecanoate NEBID
Andriol Testocaps 40 mg lágy kapszula 
Andriol Testocaps, 40 mg capsules capsule, soft oral use
2770-192 Paço d' Arcos Portugal 
2770-192 Paço d' Arcos Portugal testosterone undecanoate Andriol - T
14, J.E.Mommaerstlaan 1831 Diegem (Machelen) Belgium 
Luxembourg Bayer S.A.-N.V. 14, J.E.Mommaerstlaan 1831 Diegem (Machelen) Belgium testosterone undecanoate Nebido
Storbritannien Prostrakan Limited 3 Galabank Business Park Queen Street, Galashiels TD1 1QH 
Prostrakan Limited 3 Galabank Business Park Queen Street, Galashiels TD1 1QH
Germany testosterone enantate Testoviron-Depot Jenapharm 
Testoviron-Depot Jenapharm
Kutan transdermal anvendelse 
Testogel cutaneous transdermal use
24109 Kiel Germany testosterone enantate Testosteron-Depot GALEN 250mg 
Testosteron-Depot GALEN 250mg
Kutan og transdermal formuleringer 
Tostrex cutaneous and transdermal preparations
Injektionsvæske, suspension 
Agovirin depot suspension for injection
34, avenue Léonard de Vinci 92400 Courbevoie France 
MSD France 34, avenue Léonard de Vinci
N.V. 
Annex I
Luxembourg N.V. 
Lithuania N.V. ORGANON P.O.
Czech Republic testosterone isobutyrate Agovirin depot 
Czech Republic testosterone isobutyrate
Grækenland Laboratoires Besins International,Paris,France 5, rue de Bourg l' Abbe 75003 Paris 
Laboratoires Besins International,Paris,France 5, rue de Bourg l' Abbe 75003 Paris
Greece testosterone enantate Testoviron 
Germany testosterone enantate
Bayer Pharma AG Müllerstrasse 178 13353 Berlin Germany testosteronum undecanoat 
Bayer Pharma AG Müllerstrasse 178 13353 Berlin Germany testosteronum undecanoat Nebido
United Kingdom testosterone propionate Virormone (100mg/2ml) 
Virormone (100mg/2ml)
Organon Kloosterstraat 6 5349 AB Oss The Netherlands 
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosteronundecanoaat
Nebido 1000 mg/4ml, solution for injection 
Nebido 1000 mg/4 ml, oplossing voor injectie
Germany testosterone undecanoat NEBIDO 1000 mg/4 ml 
Germany testosterone undecanoate Nebido 1000 mg/4 ml solution for injection
Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoat Andriol Testocaps 40 mg - Kapseln 
N.V. ORGANON Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate Undestor Testocaps 40 mg capsule oral use
Rumænien BAYER PHARMA AG Müllerstraße 178 
Denmark Bayer Pharma AG Müllerstrasse 170-178
Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosteronundecanoaat Andriol Testocaps, 40 mg capsules 
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoate UNDESTOR TESTOCAPS 40 mg, capsule moi capsules soft
ORGANON Kloosterstraat 6 5349 AB Oss The Netherlands 
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoat
1.8 mg/24h Depotplaster 
1.8 mg/24h transdermal patch
Nebido 1000 mg/4 ml solution for injection 
Nebido 1000 mg/4 ml Injektionslösung
2.4 mg/24h Depotplaster 
2.4 mg/24h transdermal patch
France testosteron 
testosteron
Slovenien Bayer Pharma AG 13342 Berlin 
Sweden Bayer Pharma AG DE-13342 Berlin
1000 mg/dose Injektionsvæske, opløsning 
1000 mg/dose solution for injection
1.2 mg/24h Depotplaster 
1.2 mg/24h transdermal patch
REANDRON 1000 mg/4 ml solución inyectable 
Spain testosterone undecanoate REANDRON 1000 mg/4 ml solución inyectable
Laboratoires Besins international 3 rue du Bourgl Abbe 75003 Paris France testosteron 
3 rue du Bourgl Abbe 75003 Paris testosteron
2.4 mg/24 h Depotplaster 
2.4 mg/24 h transdermal patch
1.8 mg/24 h Depotplaster 
1.8 mg/24 h transdermal patch
3, rue du Bourg l'Abbé 75003 Paris 
3 rue du Bourgl Abbe 75003 Paris
Testocaps 
TESTEX
3641 RT Mijdrecht The Netherlands testosteronundecanoaat Nebido 1000 mg/4 ml, oplossing voor injectie 
3641 RT Mijdrecht The Netherlands testosteronundecanoaat
1.2 mg/24 h Depotplaster 
1.2 mg/24 h transdermal patch
Berkshire RG14 1JA United Kingdom 
Berkshire RG14 1JA United Kingdom testosterone undecanoate Nebido
Tostrex 
TESTOVIRON
Den 4 October 2010 
4 October 2010
Ved udgangen af året var 29,4 millioner mennesker i Europa blevet vaccineret med et af disse lægemidler. 
By the end of the year, 29.4 million people in Europe had been vaccinated with one of these products.
Konsolidering af EMA's internationale strategi i lyset af globale udfordringer 
Consolidating the Agency's international strategy in the light of global challenges
Fremme af gennemsigtighed, kommunikation og informationsformidling 
Fostering transparency, communication and the provision of information
Alle store virksomheder er nu registreret og foretager elektroniske indberetninger via EVVet. 
All major companies are now registered and operating electronic reporting via EVVet.
Der er nu registreret 32 kompetente myndigheder med i alt 150 forskellige brugere. 
Thirtytwo competent authorities are now registered, with a total of 150 different users.
Der er endvidere registreret 111 organisationer (indehavere af markedsføringstilladelse og tredjeparter) med i alt 176 forskellige brugere. 
There are also 111 organisations registered (marketing-authorisation holders and third parties), with a total of 176 different users.
Den 8. december 2009 præsenterede agenturet sin nye visuelle identitet. 
The Agency unveiled its new visual identity on 8 December 2009.
Gennemførelsen og udviklingen af EudraVigilance Veterinary (EVVet) fortsatte i 2009. 
The implementation and development of EudraVigilance Veterinary (EVVet) continued in 2009.
Endvidere blev de eksisterende regulerende vejledende dokumenter opdateret i henhold til de nye regler. 
Existing regulatory guidance documents were also updated, to take account of the new rules.
H1N1-influenzapandemien medførte en hidtil uset grad af internationalt samarbejde på bilateralt og multilateralt plan. 
The H1N1 influenza pandemic resulted in an unprecedented level of international cooperation activity at bilateral and multilateral level.
CHMP kunne således fremsætte positive anbefalinger for to pandemiske influenzavacciner (Focetria og Pandemrix) i slutningen af september og for en tredje vaccine (Celvapan) i begyndelsen af oktober. 
Thus, the CHMP was able to give positive recommendations for two pandemic-influenza vaccines (Focetria and Pandemrix) by late September, and for a third one (Celvapan) in early October.
Styrkelse af det europæiske lægemiddelnetværk 
Strengthening the European medicines network
Der blev endvidere i løbet af året iværksat en række pilotprojekter til fremme af internationalt samarbejde inden for inspektionsområdet. 
A number of pilot projects fostering international collaboration in the area of inspections were also launched during the year.
Gennemførelse og anvendelse af forordningen om lægemidler til avanceret terapi samt anden ny lovgivning 
Implementing and operating the Advanced Therapies Regulation and other new legislation
Højdepunkter fra EMA's årsberetning 2009 
Highlights from the Agency's annual report 2009
Forbedring af effektiviteten og virkningen af EMA's kerneaktiviteter 
Improving the effectiveness and efficiency of the Agency's core activities
Udviklingen af EMA's internationale strategi blev indledt med udpegelse af en international forbindelsesofficer i begyndelsen af 2009. 
The development of the Agency's international strategy started with the appointment of an International Liaison Officer in the beginning of 2009.
Udvalget for Avancerede Terapier er et tværfagligt udvalg bestående af nogle af de bedste eksperter inden for området. 
The CAT is a multidisciplinary committee made up of some of the best experts in the field.
Ved årets udgang blev den internationale strategi medtaget som en vigtig del af EMA's "køreplan frem til 2015", som agenturets bestyrelse vedtog at sende til offentlig høring. 
By the end of the year, the international strategy was included as an important part of the Agency's 'Road map to 2015', adopted by the Agency's Management Board for public consultation.
Det Europæiske Lægemiddelagentur (EMA) opnåede i 2009 særdeles gode resultater inden for alle sine aktivitetsområder. 
In 2009, the European Medicines Agency delivered very good results across the range of its activities.
Agenturet havde regelmæssige udvekslinger med de regulerende myndigheder i Australien, Canada, Japan og USA samt med eksperter fra WHO. 
The Agency had regular exchanges with regulators from Australia, Canada, Japan, the United States and experts from the World Health Organization (WHO).
Agenturet indgik endvidere et tæt samarbejde med Europa-Kommissionen om at styrke innovationen inden for initiativet vedrørende innovative lægemidler (IMI), det syvende rammeprogram og den europæiske teknologiplatform for global dyresundhed. 
The Agency also cooperated closely with the European Commission on fostering innovation in the context of the Innovative Medicines Initiative (IMI), the 7th Framework Programme and the European Technology Platform for Global Animal Health.
Denne plan er udarbejdet med henblik på at forbedre håndteringen og koordineringen af en given potentiel krise, der vedrører et lægemiddel, i det europæiske lægemiddelsystem. 
This plan is designed to improve the handling and coordination of any potential crisis involving a medicine in the European medicines system.
I slutningen af januar 2009 blev der indledt et EudraVigilance-støtteprogram for at bistå medlemsstaterne med deres aktiviteter vedrørende signaldetektion og evaluering. 
The EudraVigilance Support Programme was initiated at the end of January 2009 to assist Member States with their signal-detection and evaluation activities.
I begyndelsen af maj anbefalede EMA's Udvalg for Humanmedicinske Lægemidler (CHMP), at opbevaringstiden for et af disse lægemidler (Tamiflu) blev forlænget, således at de lagre af lægemidlet, der ellers skulle have været bortskaffet, fortsat kunne anvendes, hvis der blev erklæret en pandemi. 
In early May, the Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that the shelf-life of one of these medicines (Tamiflu) be extended, so that stocks of the medicine that would otherwise need to have been disposed of could continue to be used in the event of a pandemic being declared.
Det europæiske sporingsværktøj til lægemiddelovervågningssager (EPITT) bruges nu rutinemæssigt i signalstyringsprocessen. 
The European Pharmacovigilance Issues Tracking Tool (EPITT) is now routinely used to support the signal-management process.
PROTECT er et europæisk samarbejdsprojekt, hvor 29 offentlige og private partnere samarbejder om at udvikle innovative metoder inden for farmakoepidemiologi og lægemiddelovervågning. 
PROTECT is a collaborative European project bringing together 29 public and private partners, which aims to develop innovative methods in pharmacoepidemiology and pharmacovigilance.
Årsberetninghøjdepunkter 
Annual report highlights
I august 2009 underskrev EMA sin seneste fortrolighedsaftale med det australske Therapeutic Goods Administration (TGA), hvormed antallet af indgåede fortrolighedsaftaler steg til fire. 
In August 2009, the Agency signed its latest confidentiality arrangement with the Australian Therapeutic Goods Administration (TGA), bringing the number of confidentiality arrangements in place to four.
Hastevurderingen af pandemivaccinerne - og den nøje overvågning af vaccinerne, efter de blev taget i brug til at vaccinere millioner af europæiske borgere - demonstrerede for Europa og resten af verden, at det europæiske lægemiddelnetværk er i stand til at levere videnskabelige vurderinger af høj kvalitet, selv under enormt pres. 
The fast-track review of pandemic vaccines - and the close monitoring of these vaccines once they were being used to vaccinate millions of European citizens - demonstrated to Europe and to the world that the European medicines network can deliver high-quality scientific assessments even under enormous pressure.
Der blev i september 2009 lagt særlig vægt på indførelsen af en række foranstaltninger til at fremme godkendelsen af lægemidler til sjældne anvendelser, mindre arter og begrænsede markeder. 
A particular highlight was the introduction, in September 2009, of a range of measures to promote the authorisation of products for minor uses, minor species and limited markets.
I løbet af året overvågede EMA konstant sikkerhedsdataene for influenzavaccinerne og de antivirale lægemidler for at fastlægge og om nødvendigt revidere disses risk-benefit-profil. 
During the year, the Agency continuously monitored the safety data for influenza vaccines and antivirals, to establish and revise, where necessary, their benefit-risk profile.
De bilaterale forbindelser med det amerikanske Food and Drug Administration (FDA) og de japanske myndigheder blev betydeligt forstærket med aftalen om indsættelse af forbindelsesofficerer. 
Bilateral relations with the US Food and Drug Administration (FDA) and the Japanese authorities were greatly enhanced when the notion of liaison placements was agreed.
Lægemiddelovervågning af de antivirale lægemidler og vacciner, der blev brugt under influenzapandemien, var en hovedaktivitet i 2009. 
Pharmacovigilance of antivirals and vaccines used during the influenza pandemic was a major activity in 2009.