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Fax(44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Welche Unterlagen hat das Unternehmen dem CHMP zur Stützung des Antrags vorgelegt?
Fax( 44- 20) 75 23 71 29 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged ningen af at supplere patientens medicin med fenofibrat?
Fax(+44-20) 75 23 71 29 E-Mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged In welchem Stadium der Beurteilung befand sich der Antrag zum Zeitpunkt der Rücknahme?
Fax( 44- 20) 75 23 71 29 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvad anbefalede CHMP på dette tidspunkt?
Fax(44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Die Hauptstudie am Menschen wurde an 139 Erwachsenen mit invasiver Candidiasis durchgeführt?
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede afslag på ansøgningen om markedsføringstilladelse?
Fax(44-20) 74 18 86 68 E-mail: mail@emea.eu.int http://www.emea.eu.int ©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Humaninsulin(rDNA), wird mit dem Verfahren der so genannten„ rekombinanten Technologie“ hergestellt.
Fax( 44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http:// www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged som sætter den i stand til at producere insulinen.
Fax(44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged In welchem Stadium der Beurteilung befand sich der Antrag zum Zeitpunkt der Rücknahme?
Fax( 44- 20) 75 23 71 29 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged CHMP bruger normalt op til 210 dage på at evaluere en ny ansøgning?
Fax(44-20) 74 18 84 16 E-mail: mail@emea.eu.int http://www.emea.eu.int ©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Gen(DNA) eingeschleust wurde, das sie zur Bildung des menschlichen Gerinnungsfaktors IX befähigt?
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http:// www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan er BeneFIX blevet undersøgt?
Fax(44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Gen(DNA) eingeschleust wurde, das sie zur Bildung des menschlichen Gerinnungsfaktors VIII befähigt?
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan blev Helixate NexGen undersøgt?
Fax(44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Spiegel, was dazu führen kann, dass die Fähigkeit des Bluts, die Gerinnung zu hemmen,?
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan blev ATryn undersøgt?
Fax(44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged so genannten glykosylierten Hämoglobins(HbA1c), gemessen, die anzeigt, wie gut der Blutzucker eingestellt ist?
Fax( 44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvilken fordel viser undersøgelserne, at der er ved Trazec?
Fax(44-20) 74 18 84 16 E-mail: mail@emea.eu.int http://www.emea.eu.int ©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Substanz, des so genannten Endothelin-1(ET-1) entgegen, das eine schwere Verengung der Blutgefäße hervorruft?
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http:// www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan er Thelin blevet undersøgt?
Fax(44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Gutachten des CHMP dauert es in der Regel etwa 2 Monate, bis die Europäische Kommission eine Zulassung erteilt?
Fax( 44- 20) 75 23 71 29 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvori bestod CHMP' s vigtigste betænkeligheder?
Fax(44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Was waren die größten Bedenken, die den CVMP zur Versagung der Genehmigung für das Inverkehrbringen veranlasst haben?
Fax( 44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged derfor af den opfattelse, at fordelene ved Veraflox ikke havde vist sig at være større end risiciene?
Fax(44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Studien wurden die Wirkungen von Riprazo als allein verabreichtem Arzneimittel mit denjenigen von Placebo(einem Scheinmedikament) verglichen.
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged receptorblokker( valsartan), en betablokker( atenolol), en kalciumkanalblokker( amlodipin) og et vanddrivende middel hydrochlorthiazid.
Fax(44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Impfstoff, wurde jedoch inaktiviert(d. h. die Viren wurden abgetötet), so dass keine Erkrankung ausgelöst werden kann.
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Når man bliver vaccineret, opfatter immunsystemet de svækkede virus som" fremmede" og producerer antistoffer mod dem.
Fax(44-20) 74 18 84 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged über 6 Monate wurde die Wirksamkeit von TRAVATAN als Ergänzungstherapie für Patienten untersucht, denen gleichzeitig auch Timolol verabreicht wurde?
Fax( 44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvilken fordel viser undersøgelserne, at der er ved TRAVATAN?
Fax(44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2008 Reproduction and/or distribution of this document is authorised provided the source is acknowledged Wenn eine Katze den Impfstoff erhält, erkennt das Immunsystem die abgeschwächten bzw. abgetöteten Viren als„ fremd“ und stellt Antikörper gegen sie her?
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised provided the source is acknowledged Hvordan blev Purevax RC undersøgt?
Fax(44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged entweder PRILACTONE-Tabletten oder ein Scheinmedikament ohne jeglichen Wirkstoff(Placebo) in der Dosis von 2 mg/kg zusammen mit dem Futter.
Fax( 44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged endvidere‘ standardbehandling' normalt et andet lægemiddel i gruppen‘ ACE- hæmmere' og om nødvendigt vanddrivende behandling.
Fax(44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Die Wirkungen von Circadin wurden zudem in drei Hauptstudien an insgesamt 681 Patienten über 55 Jahren mit primärer Insomnie untersucht.
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Circadin med virkningerne af placebo en uvirksom behandling.
Fax(44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Der arzneilich wirksame Bestandteil in CHAMPIX, Vareniclin, kann sich an einige dieser Rezeptoren, die α 4β 2-nikotinergen Acetylcholin-Rezeptoren,?
Fax( 44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan er CHAMPIX blevet undersøgt?
Fax(44-20) 74 18 84 47 E-mail: mail@emea.europa.eu http://www.emea.europa.eu ©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Previcox Kautabletten für Hunde wurden in zwei großen europäischen Feldstudien über einen Zeitraum von bis zu 90 Tagen an Hunden untersucht.
Fax( 44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http:// www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged havde fået konstateret ledbetændelse.
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