natgillin/translations-raw huggingface dataset:
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.
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.
Pandeemiavaktsiinide väga kiire ülevaatamine - ning nende hoolikas järelevalve alates vaktsiinide kasutamisest miljonite Euroopa kodanike vaktsineerimiseks - näitas Euroopale ja kogu maailmale, et Euroopa ravimivõrgustik on isegi tugeva surve all võimeline tegema kõrgetasemelisi teaduslikke hindamisi.
On the basis of these scientific recommendations, the European Commission granted EU-wide marketing authorisations for all three vaccines, making them available for use by health authorities in the EU Member States as part of their national vaccination programmes.
Euroopa Komisjon andis nimetatud teaduslike soovituste põhjal kõigi kolme vaktsiini kogu Euroopa Liidus kehtivad müügiload, mis võimaldas Euroopa Liidu liikmesriikide tervishoiuasutustel kasutada neid vaktsiine oma riiklike vaktsineerimisprogrammide raames.
All major companies are now registered and operating electronic reporting via EVVet.
Nüüdseks on kõik suured ettevõtjad registreerunud ja osalevad elektroonilises aruandluses EudraVigilance'i veterinaarsüsteemi kaudu.
Contributing to improved availability of medicines
Ravimite paremale kättesaadavusele kaasaaitamine
These innovative medicines offer groundbreaking new treatment opportunities for diseases and injuries of the human body.
Need uuenduslikud ravimid pakuvad haiguste ja kehavigastuste murrangulisi uusi ravivõimalusi.
The implementation and development of EudraVigilance Veterinary (EVVet) continued in 2009.
2009. aastal jätkus EudraVigilance'i veterinaarsüsteemi rakendamine ja arendamine.
While many resources were devoted to dealing with the influenza pandemic, the European medicines network also made progress on a number of other initiatives during the year: work on the European Risk Management Strategy (ERMS) continued in accordance with the rolling two-year work programme; the Agency worked jointly with the Heads of Medicines Agencies (HMA) on developing a training strategy for the regulatory network; further progress was made on simplifying the contractual arrangements with the Member States for services provided to the Agency through the development of a Cooperation Agreement.
Samal ajal, kui hulgaliselt ressursse oli suunatud gripipandeemia küsimuse lahendamisele, tegi Euroopa ravimivõrgustik aasta jooksul edusamme ka mitmes muus algatuses: töö Euroopa riskijuhtimisstrateegiaga (ERMS) jätkus vastavalt kaheaastasele jooksvale tööprogrammile, EMA tegi koostööd ravimiametite juhtidega regulatiivvõrgustiku koolitusstrateegia väljatöötamisel; lihtsustati ka EMA-le osutatavate teenuste suhtes liikmesriikidega sõlmitavate lepingute korda, töötades välja koostöökokkuleppe.
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.
Mai alguses soovitas EMA inimravimite komitee pikendada ühe efektiivse ravimi (Tamiflu) säilivusaega, et pandeemia väljakuulutamisel saaks jätkata ravimi varude kasutamist, mis vastasel juhul oleks tulnud hävitada.