natgillin/translations-raw huggingface dataset:
itraconazole, protease inhibitors, macrolides etc may markedly increase the plasma concentrations of lansoprazole. 
makroliidid, jne, võivad märkimisväärselt suurendada lansoprasooli kontsentratsiooni plasmas.
Administration of lansoprazole may result in subtherapeutic concentrations of ketoconazol and itraconazol and the combination should be avoided. 
Lansoprasooli manustamine võib tähendada seda, et ketokonasooli ja itrakonasooli kasutamise korral saavutatakse organismis vaid subterapeutilised kontsentratsioonid, mistõttu tuleks vältida nende ravimite samaaegset kasutamist lansoprasooliga.
amoxicillin 
Meglumiin
Impaired hepatic or renal function: 
Häiritud maksa- või neerufunktsioon:
palpitation and chest pain. 
südamekloppimine ja rindkerevalu.
It inhibits the final stage of gastric acid formation by inhibiting the activity of H +/K 
Ta inhibeerib maohappe moodustumise lõppetappi,
• Treatment of reflux oesophagitis. 
• Refluksösofagiidi ravi.
Increase bioaivalability and half-life of lansoprazole by 30 % each; increased plasma amoxicillin levels of a clarithromycin metabolite by 30 % 
klaritromütsiini metaboliidi 30% suurem plasmakontsentratsioon.
clarithromycin and either amoxycillin or metronidazole are the most widely accepted treatment for 
klaritromütsiini ja kas amoksitsilliini või metronidasooliga.
H. pylori eradication rate of between 80 and 90%. 
Lansoprasooli kombineerimisel antibiootikumidega kas kahe- või kolmekordses ravis on H. pylori eradikatsioonimäär olnud vahemikus 80-90%.
Effects of lansoprazole on other drugs 
Lansoprasooli mõju teistele ravimitele Ketokonasool ja itrakonasool
Monitoring of tacrolimus plasma concentrations is advised when concomitant treatment with lanzoprazole is initiated or ended. 
Lansoprasooli lisamisel või lõpetamisel on soovitatav jälgida takroliimuse kontsentratsiooni plasmas.
agranulocytosis 
Agranulotsütoos
Treatment of reflux oesophagitis: 
Maohaavandi ravi:
Elderly: Due to delayed elimination of lansoprazole in the elderly it may be necessary to administer the treatment in doses of 15-30 mg adjusted to individual requirements. 
vastavalt individuaalsele tarvidusele, vajalikuks osutuda ravimi kasutamine annuses 15...30 mg.
Gastro-resistant capsule, hard Oral use 
Gastroresistentne kõvakapsel Peroraalne
In two rat carcinogenicity studies, lansoprazole produced dose-related gastric ECL cell hyperplasia and 
Kahes kartsinogeensuse uuringus rottidel põhjustas lansoprasool annussõltuvat mao enterokromafiinrakkude sarnaste rakkude hüperplaasiat ja kartsinoidi, mida seostati maohappe sekretsiooni pärssimisest tingitud hüpergastrineemiaga, ja reetina atroofiat.
15 mg once daily. 
Refluksösofagiidi profülaktika: 15 mg üks kord ööpäevas.
Drugs metabolised by CYP3A4 
CYP3A4 ensüümi abil metaboliseeritavad ravimid
leucopenia. 
genotüübist.
Holder 
Üldine
Investigations 
Üleannustamine
+/K +ATPase causing inhibition of the enzyme activity. 
ATPaasi sulfhüdrüülrühmaga ning inhibeerib ensüümi tegevuse.
glossitis, candidiasis of oesophagus, pancreatitis colitis, stomatitis and black tongue. 
Suu või kurgu kuivus, glossiit, söögitoru kandidoos, pankreatiit.
The enzyme CYUP3A4 
Metabolismis osaleb ka ensüüm CYP3A4.
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Kasulikkuse ja riski vahekorda puudutavad kaalutlused
Gastro-resistant capsule, hard 
Kapsli kest:
Endocrine disorders gynecomastia, galactorrhoea. 
Närvisüsteem Peavalu, pearinglus.
Mannitol Hypromellose Macrogol 6000 Talc 
inhibeerides mao parietaalrakkude H
Care should be exercised in the administration of lansoprazole in patients with mildly to moderately impaired hepatic function. 
Kerge kuni mõõduka maksafunktsiooni häirega patsientidele võib lansoprasooli manustada ettevaatusega.
A single oral dose of lansoprazole 
Naatrium laurüülsulfaat
Effects on Ability to Drive and Use Machines 
Hoiatused ja ettevaatusabinõud kasutamisel
Undesirable effects for possible symptoms of lansoprazole overdose. 
Võimalikke lansoprasooli üleannustamise sümptomeid vaata lõik 4.8.
Helicobacter pylori infection. 
Kõige laialdasemalt tunnustatakse Helicobacter pylori infektsiooniravina kolmekordset ravi prootonpumba inhibiitori,
It has a corresponding effect on the basal secretion of gastric acid. 
Toime maohappe basaalsekretsioonile on sarnane.
Denmark Eli Lilly Danmark A/S Lyskær 3E, 2.tv. 
Eli Lilly Danmark A/S Lyskær 3E, 2.tv.
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, and marketing authorisation holders in the Member States 
Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside ja müügiloa hoidjate loetelu liikmesriikides
Sweden Eli Lilly Sweden AB Box 721 
Eli Lilly Sweden AB Box 721
Ringener Str. 45 
KG Ringener Str. 45
Sweden Ferring Läkemedel AB Box 4041 
Ferring Läkemedel AB Box 4041
Germany MSD Sharp&Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1 
MSD Sharp&Dohme Gesellschaft mit beschränkter Haftung Lindenplatz 1
Nebido parenteral use 
Nebido parenteraalne
79111 Freiburg 
79111 Freiburg Germany
N.V. Organon Postbus 20 
Organon Postbus 20
33611 Bielefeld 
33611 Bielefeld Germany
Luxembourg Eli Lilly Benelux S.A. -N.V 1, rue du Marquis 
Luksemburg Eli Lilly Benelux S.A. -N.V 1, rue du Marquis
Germany Laboratoires Besins international 
Ühendkuningriik Laboratoires Besins International
Belgium Bayer SA-NV Jan Emiel Mommaertslaan 
Bayer SA-NV Jan Emiel Mommaertslaan
Germany Lilly Deutschland GmbH Teichweg 3 
Lilly Deutschland GmbH Teichweg 3
1000 Brussels 
1000 Brussels Belgium
Luxembourg Ferring S.A. 93C, Capucienenlaan 9300 Aalst 
Luksemburg Ferring S.A. 93C, Capucienenlaan 9300 Aalst
Germany Ferring Arzneimittel GmbH Fabrikstr.7 
Ferring Arzneimittel GmbH Fabrikstr.7
1831 Machelen Belgium testosterone undecylate 
1831 Machelen Belgium testosterone undecylate Nebido
Germany Eifelfango ChemischPharmazeutische Wrke GmbH&Co. 
Eifelfango ChemischPharmazeutische Wrke GmbH&Co.
Germany Pierre Faber Pharma GmbH Jechtlinger Str. 13 
Pierre Faber Pharma GmbH Jechtlinger Str. 13
Germany Dr. August Wolff GmbH&Co. 
Dr. August Wolff GmbH&Co.
Agovirin depot suspension for injection 
Agovirin depot süstesuspensioon intramuskulaarne
Merck Sharp & Dohme Limited 
Ühendkuningriik Merck Sharp & Dohme Limited
Bayer House Strawberry Hill, Newbury RG14 1JA 
Strawberry Hill, Newbury RG14 1JA
Italy testosterone propionate 
Italy testosterone propionate TESTOVIS
Norma Ellas AE Menandrou 54 10431 Athens Greece testosterone enantate 
Norma Ellas AE Menandrou 54 10431 Athens Greece testosterone enantate Testosterone Enenthate/Norma
15125 Marousi Greece testosterone enantate 
15125 Marousi Greece testosterone enantate Testoviron
2% w/w gel 
2% w/w geel
Germany Jenapharm GmbH&CO. 
Jenapharm GmbH&CO.
N.V. Organon PO BOX 20 
Organon PO BOX 20
Belgium Ferring SA-NV Capucienenlaan 93C 9300 Aalst 
Ferring SA-NV Capucienenlaan 93C 9300 Aalst Belgium
Testotop Gel 62,5mg 62,5 mg/2,5g gel 
Testotop Gel 62,5mg 62,5 mg/2,5g geel
Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate 
Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate TESTO ENANT
28029 Madrid Spain testosterone propionate 
28029 Madrid Spain testosterone propionate TESTEX
Luxembourg Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business 
Luksemburg Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business
GEYMONAT S.P.A., Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate 
GEYMONAT S.P.A., Via S. Anna, 2 03012 Anagni Frosinone Italy testosterone enanthate TESTO ENANT
Alliance Pharmaceuticals Limited 
Ühendkuningriik Alliance Pharmaceuticals Limited
Germany GALENpharm GmbH Wittland13 
GALENpharm GmbH Wittland13
22,5 mg/patch patch 
22,5 mg/patch plaaster
BAYER SANTE 220, avenue de la Recherche, 59120 Loos France testosterone enantate 
BAYER SANTE 220, avenue de la Recherche 59120 Loos France
Testosteron-Depot 250mg Eifelfango 
Germany testosterone enantate Testosteron-Depot 250mg Eifelfango
Axiron 30mg/1,5ml Lösung zur Anwendung auf der Haut solution 
Axiron 30mg/1,5ml Lösung zur Anwendung auf der Haut lahus
Testotop Gel 125mg 125 mg/5g gel 
Testotop Gel 125mg 125 mg/5g geel
35396 Gießen 
35396 Gießen Germany
BAYER SANTE 220, avenue de la Recherche 59120 Loos France testosterone undecanoate NEBIDO 1000 mg/4 ml, solution injectable 
BAYER SANTE 220, avenue de la Recherche, 59120 Loos France testosterone enantate ANDROTARDYL 250 mg/1 ml, solution injectable intramusculaire lahus
Viale Certosa, 130 20156 Milano Italy testosterone enanthate 
Viale Certosa, 130 20156 Milano Italy testosterone enanthate TESTOVIRON
Nebido 250 mg/ml oldatos injekció intramuscular injection 
Nebido 250 mg/ml oldatos injekció intramuskulaarne süstelahus
Testoviron-Depot-250 250 mg/ml 
Germany testosterone enantate Testoviron-Depot-250 250 mg/ml
AGOVIRIN DEPOT 5 mg/2 ml suspension for injection 
AGOVIRIN DEPOT 5 mg/2 ml süstesuspensioon intramuskulaarne
Ferring Pharmaceuticals Limited 
Ühendkuningriik Ferring Pharmaceuticals Limited
FERRING Pharmaceuticals CZ s.r.o. 
Tšehhi Vabariik FERRING Pharmaceuticals CZ s.r.o.
Axxeron transdermal spray, solution 
Axxeron transdermaalne sprei, lahus
Lithuania Ferring Lääkkeet Oy PL 23 
Ferring Lääkkeet Oy PL 23
Czech Republic estradiol/testosterone 
Czech Republic estradiol/testosterone FOLIVIRIN
1 g/100 g gel 
1 g/100 g geel
Bayer Portugal, S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal testosterone enantate 
Bayer Portugal, S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal testosterone enantate Testoviron Depot
Lithuania Bayer Pharma AG Mullerstrasse 178 
Tšehhi Vabariik Bayer Pharma AG Müllerstrasse 178
30 mg/patch patch 
30 mg/patch plaaster
Belgium Aspen Pharma Trading Limited, 3016 Lake Drive Citywest Business Campus Dublin 24 
Aspen Pharma Trading Limited, 3016 Lake Drive Citywest Business Campus Dublin 24
Belgium Besins Healthcare Avenue Louise 287 
Besins Healthcare Avenue Louise 287 1050 Brussels Belgium
2 g/100 g gel 
2 g/100 g geel
50 mg/5 g transdermal gel 
50 mg/5 g transdermaalne geel
15 mg/patch patch 
15 mg/patch plaaster
Germany Rotexmedica GmbH Arzneimittelwerk 
Rotexmedica GmbH Arzneimittelwerk Bunsenstr.4
Via Vitorchiano 151 00189 Roma Italy testosterone undecanoate ANDRIOL 
Via Vitorchiano 151 00189 Roma Italy
Androtop Gel 25mg 25 mg/2,5g gel 
Androtop Gel 25mg 25 mg/2,5g geel
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone propionate testosterone phenylpropionate testosterone isocaproate testosterone decanoate 
Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone propionate testosterone phenylpropionate testosterone isocaproate testosterone decanoate
Tostrex cutaneous and transdermal preparations 
Tostrex kutaansed ja transdermaalsed preparaadid
Organon (Ireland) Limited PO Box 2857, Drynam Road, Swords Co. Dublin Ireland testosterone undecanoate Restandol Testocaps 40 mg capsules, soft oral use 
Organon (Ireland) Limited PO Box 2857, Drynam Road, Swords Co. Dublin Ireland
Lithuania N.V. ORGANON P.O. 
ORGANON P.O.
Axxeron cutaneous solution 
Axxeron nahalahus
Testosterone Enantate Ampoules 
United Kingdom testosterone enantate Testosterone Enantate Ampoules
DHP Healthcare Limited 26 Pickering Street Maidstone, Kent ME15 9RS 
Ühendkuningriik DHP Healthcare Limited 26 Pickering Street
Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom testosterone undecanoate Restandol 40mg capsule oral use 
Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoat 
Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosterone undecanoat
Testosteron-Depot Jenapharm 
Germany testosterone enantate Testosteron-Depot Jenapharm
Testosteronum prolongatum Jelfa 
Czech Republic testosterone enantane Testosteronum prolongatum Jelfa
ANDROGEL 50 mg 50 mg/5 g gel 
ANDROGEL 50 mg 50 mg/5 g geel
Andriol Testocaps 40 mg - Kapseln capsule, soft oral use 
Andriol Testocaps 40 mg - Kapseln pehmekapsel suukaudne
Androtop Gel 50mg 50 mg/5g gel 
Androtop Gel 50mg 50 mg/5g geel
DE-13342 Berlin 
13353 Berlin
Denmark Ferring Lægemidler A/S, Kay Fiskers Plads 11 
Ferring Lægemidler A/S, Kay Fiskers Plads 11 DK-2300 København S Denmark
BAYER S.P.A., Viale Certosa, 130 20156 Milano Italy testosterone undecanoate NEBID 
BAYER S.P.A., Viale Certosa, 130 20156 Milano Italy
50 mg/sachet gel 
50 mg/sachet geel
2770-192 Paço d' Arcos Portugal testosterone undecanoate Andriol - T 
2770-192 Paço d' Arcos Portugal
25 mg/sachet gel 
25 mg/sachet geel
Prostrakan Limited 3 Galabank Business Park Queen Street, Galashiels TD1 1QH 
Ühendkuningriik Prostrakan Limited 3 Galabank Business Park Queen Street, Galashiels TD1 1QH
25 mg/ml 2,5 mg/ml suspension for injection 
25 mg/ml 2,5 mg/ml süstesuspensioon intramuskulaarne
2,5 mg/25 mg/ ml suspension for injection 
2,5 mg/25 mg/ ml süstesuspensioon intramuskulaarne
Annex I 
N.V.
Testoviron-Depot Jenapharm 
Germany testosterone enantate Testoviron-Depot Jenapharm
25 mg/dosage gel 
25 mg/dosage geel
Luxembourg Bayer S.A.-N.V. 14, J.E.Mommaerstlaan 1831 Diegem (Machelen) Belgium testosterone undecanoate Nebido 
14, J.E.Mommaerstlaan 1831 Diegem (Machelen) Belgium
50 mg/dosage gel 
50 mg/dosage geel
Sweden N.V. Organon Kloosterstraat 6 
Organon Kloosterstraat 6
Testosteron-Depot GALEN 250mg 
24109 Kiel Germany testosterone enantate Testosteron-Depot GALEN 250mg
Avonbridge House Bath Road, Chippenham Wiltshire SN15 2BB United Kingdom testosterone enantate 
Avonbridge House Bath Road, Chippenham
Testogel gel in sachet cutaneous and transdermal preparations 
Testogel geel kotikeses kutaansed ja transdermaalsed preparaadid
Luxembourg Prostrakan Ltd Galabank Business Park Galashiels 
Luksemburg Prostrakan Ltd Galabank Business Park Galashiels
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 testosteronundecanoaat Andriol Testocaps, 40 mg capsules pehmekapsel suukaudne
2,4mg/24h, transdermales Pflaster transdermal patch 
2,4mg/24h, transdermales Pflaster transdermaalne plaaster
50 mg/5g gel 
50 mg/5g geel
Testim cutaneous transdermal use 
Testim kutaanne transdermaalne
Testim cutaneous and transdermal preparations 
Testim kutaansed ja transdermaalsed preparaadid
1,8mg/24h, transdermales Pflaster transdermal patch 
1,8mg/24h, transdermales Pflaster transdermaalne plaaster
capsules oral use 
kapslid suukaudne
50 mg/5 g gel 
50 mg/5 g geel
Virormone (100mg/2ml) 
United Kingdom testosterone propionate Virormone (100mg/2ml)
Nebido 1000 mg/4 ml, oplossing voor injectie 
Nebido 1000 mg/4ml, solution for injection
1,2mg/24h, transdermales Pflaster transdermal patch 
1,2mg/24h, transdermales Pflaster transdermaalne plaaster
Andriol Testocaps, 40 mg capsules capsule, soft oral use 
Andriol Testocaps 40 mg lágy kapszula pehmekapsel suukaudne
Sweden ProStrakan Ltd, Galabank Business Park Galashiels 
ProStrakan Ltd, Galabank Business Park Galashiels
25 mg/dose gel 
25 mg/dose geel
The Netherlands testosterone undecanoate Undestor® Testocaps® 
Germany testosterone undecanoate (testosterone)
25 mg/2.5 g gel 
25 mg/2.5 g geel
25 mg/2,5 g gel 
25 mg/2,5 g geel
Bayer Pharma AG Müllerstraße 178 D-13353 Berlin Germany testosteron undecanoate Nebido 
Bayer Pharma AG Müllerstraße 178 D-13353 Berlin Germany testosteron undecanoate
Spain testosterone undecanoate REANDRON 1000 mg/4 ml solución inyectable 
REANDRON 1000 mg/4 ml solución inyectable
testosteron 
France testosteron
Germany testosterone undecanoate Nebido 1000 mg/4 ml solution for injection 
3641 RT Mijdrecht The Netherlands testosteronundecanoaat Nebido 1000 mg/4 ml, oplossing voor injectie
50 mg/dose gel 
50 mg/dose geel
Bayer Pharma AG Müllerstrasse 178 13353 Berlin Germany testosteronum undecanoat Nebido 
Bayer Pharma AG Müllerstrasse 178 13353 Berlin Germany testosteronum undecanoat
25 mg/2,5g gel 
25 mg/2,5g geel
Belgium Eli Lilly Benelux S.A.-N.V. Rue du Marquis 1 
Eli Lilly Benelux S.A.-N.V.
Belgium ProStrakan Ltd. Galabank Business Park TD1 1QH Galashiels Selkirkshire 
Galabank Business Park TD1 1QH Galashiels Selkirkshire
2.4 mg/24 h transdermal patch 
2.4 mg/24 h transdermaalne plaaster
N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands testosteronundecanoaat 
Organon Kloosterstraat 6 5349 AB Oss The Netherlands
2.4 mg/24h transdermal patch 
2.4 mg/24h transdermaalne plaaster
1.8 mg/24h transdermal patch 
1.8 mg/24h transdermaalne plaaster
Sweden Laboratoires Besins International, 3, rue du Bourg l´ Abbé FR-75003 Paris 
Laboratoires Besins International, 3, rue du Bourg l´ Abbé FR-75003 Paris
1.8 mg/24 h transdermal patch 
1.8 mg/24 h transdermaalne plaaster
3 rue du Bourgl Abbe 75003 Paris testosteron 
Laboratoires Besins international 3 rue du Bourgl Abbe 75003 Paris France testosteron
Denmark Laboratoires Besins Int., 3 rue du Bourg l'Abbé 75003 Paris 
Laboratoires Besins Int., 3 rue du Bourg l'Abbé 75003 Paris
Axiron cutaneous solution cutaneous and transdermal preparations 
Axiron nahalahus kutaansed ja transdermaalsed preparaadid
Axiron cutaneous solution 
Axiron nahalahus
Androgel 50 mg gel in sachet gel in sachet 
Androgel 50 mg gel in sachet geel kotikeses kutaanne
1.2 mg/24 h transdermal patch 
1.2 mg/24 h transdermaalne plaaster
1.2 mg/24h transdermal patch 
1.2 mg/24h transdermaalne plaaster
22946 Trittau 
92400 Courbevoie France
Androgel 25 mg gel in sachet gel in sachet 
Androgel 25 mg gel in sachet geel kotikeses kutaanne
Sweden Bayer Pharma AG DE-13342 Berlin 
Bayer Pharma AG DE-13342 Berlin Germany
3, rue du Bourg l´ Abbé FR-75003 Paris 
5 Rue du Bourg L'Abbe Paris F-75003
Testogel cutaneous transdermal use 
Testogel kutaanne transdermaalne
Berkshire RG14 1JA United Kingdom testosterone undecanoate Nebido 
Berkshire RG14 1JA United Kingdom
Denmark Laboratoires Besins Int. 3 rue du Bourg l'Abbé 75003 Paris 
Laboratoires Besins Int. 3 rue du Bourg l'Abbé 75003 Paris France
Luxembourg Besins International S.A. 3, rue du Bourg l'Abbe 75003 Paris 
Luksemburg Besins International S.A. 3, rue du Bourg l'Abbe
4 October 2010 
4 oktoober 2010
Fostering transparency, communication and the provision of information 
Läbipaistvuse, teabevahetuse ja teabe pakkumise edendamine
By the end of the year, 29.4 million people in Europe had been vaccinated with one of these products. 
Aasta lõpuks vaktsineeriti Euroopas ühega eespool nimetatud vaktsiinidest 29,4 miljonit inimest.
There are also 111 organisations registered (marketing-authorisation holders and third parties), with a total of 176 different users. 
Registreeritud on ka 111 organisatsiooni (müügiloa hoidjad ja kolmandad isikud) kokku 176 kasutajaga.
Consolidating the Agency's international strategy in the light of global challenges 
EMA rahvusvahelise strateegia tugevdamine ülemaailmsete väljakutsete taustal
Existing regulatory guidance documents were also updated, to take account of the new rules. 
Ka kehtivad regulatiivsuunised ajakohastati vastama uute eeskirjadega.
Strengthening the European medicines network 
Euroopa ravimivõrgustiku tugevdamine
Thirtytwo competent authorities are now registered, with a total of 150 different users. 
Praegu on süsteemis registreeritud 32 pädevat asutust kokku 150 kasutajaga.
Improving the effectiveness and efficiency of the Agency's core activities 
EMA võtmetegevuste tulemuslikkuse ja tõhususe parandamine
This plan is designed to improve the handling and coordination of any potential crisis involving a medicine in the European medicines system. 
Kava eesmärk on parandada Euroopa ravimisüsteemis ravimitega seotud mis tahes võimaliku kriisiolukorra juhtimist ja koordineerimist.
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. 
Tänu sellele sai inimravimite komitee anda positiivseid soovitusi kahele pandeemilise gripi vaktsiinile (Focetria ja Pandemrix) septembri lõpuks ning kolmandale vaktsiinile (Celvapan) oktoobri alguses.
PROTECT is a collaborative European project bringing together 29 public and private partners, which aims to develop innovative methods in pharmacoepidemiology and pharmacovigilance. 
PROTECT on koostööpõhine Euroopa projekt, milles osaleb 29 avaliku ja erasektori partnerit ning mille eesmärk on töötada välja farmakoepidemioloogia ja ravimiohutuse järelevalve uuenduslikud meetodid.
Although the Agency devoted significant time and resources in 2009 to its involvement in managing the unanticipated influenza pandemic, it was still able to achieve very good results in delivering on its ambitious work programme for the year. 
Kuigi 2009. aastal kulutas EMA märkimisväärselt aega ja ressursse ootamatu gripipandeemia ohjamises osalemisele, saavutas ta oma ambitsioonika 2009. aasta tööplaani täitmisel ikkagi väga häid tulemusi.
The EudraVigilance Support Programme was initiated at the end of January 2009 to assist Member States with their signal-detection and evaluation activities. 
2009. aasta jaanuari lõpus algas EudraVigilance'i toetusprogramm, et aidata liikmesriike ohusignaalide tuvastamisel ja hindamisel.
Highlights from the Agency's annual report 2009 
2009. aasta aruande põhipunktid
The Agency had regular exchanges with regulators from Australia, Canada, Japan, the United States and experts from the World Health Organization (WHO). 
Ravimiamet vahetas pidevalt teavet Austraalia, Kanada, Jaapani ja USA reguleerivate ametitega ning Maailma Terviseorganisatsiooni (WHO) ekspertidega.
In 2009, the European Medicines Agency delivered very good results across the range of its activities. 
2009. aastal saavutas Euroopa Ravimiamet (EMA) mitmes tegevusvaldkonnas väga häid tulemusi.
The H1N1 influenza pandemic resulted in an unprecedented level of international cooperation activity at bilateral and multilateral level. 
Gripiviiruse H1N1 pandeemia tulemusena tõusis rahvusvaheline kahe- ja mitmepoolne koostöö ennenägematule tasemele.
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. 
EMA tegi ka tihedat koostööd Euroopa Komisjoniga innovatsiooni edendamisel uuenduslike ravimite algatuse, seitsmenda raamprogrammi ja ülemaailmse loomatervishoiu Euroopa tehnoloogiaplatvormi raames.
A number of pilot projects fostering international collaboration in the area of inspections were also launched during the year. 
Lisaks käivitati aasta jooksul mitu inspekteerimise katseprojekti, mis edendasid rahvusvahelist koostööd.
The development of the Agency's international strategy started with the appointment of an International Liaison Officer in the beginning of 2009. 
EMA rahvusvahelise strateegia väljatöötamine algas 2009. aasta alguses rahvusvahelise kontaktametniku määramisega.
Implementing and operating the Advanced Therapies Regulation and other new legislation 
Uudsete ravimite määruse ja muude uute õigusaktide rakendamine ning toimimine
The influenza pandemic was by definition a global challenge, so much credit for the achievements in Europe is also owed to the international partners with which the EU enjoys a mutually beneficial working relationship, notably the World Health Organization and the medicines authorities of the United States, Japan, Canada and Australia, among others. 
Gripipandeemia oli oma olemuselt ülemaailmne väljakutse; seega kuulub osa Euroopa saavutuste eest saadud suurest tunnustusest ka Euroopa Liidu rahvusvahelistele partneritele, kellega liidul on vastastikku kasulikud töösuhted, nimelt Maailma Terviseorganisatsioonile ja muuhulgas Ühendriikide, Jaapani, Kanada ning Austraalia ravimiametitele.