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Die Verbreitung dieses Dokuments und/oder der Verkauf bestimmter Produkte unterliegen Einschränkungen z.B.Fax(44-20) 74 18 84 16 E-mail: mail@emea. eu. int http://www. emea.eu. int EMEA 2004 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
Fax(44-20) 74 18 84 16 E-mail: mail@emea.eu.int http://www.emea.eu.int EMEA 2004 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Das Verzeichnis der Bezeichnungen des Arzneimittels ist in Anhang I enthalten.The distribution of this document and the offering of the Securities in certain jurisdictions may be restricted by law.
Die Aushändigung dieses Basisprospekts und das Angebot der Wertpapiere können in bestimmten Ländern durch Rechtsvorschriften eingeschränkt sein.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 What is the risk associated with Vaniqa?
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 Welchen Nutzen hat Vaniqa in diesen Studien gezeigt?Distribution of this document and/or the sale of certain products are subject to restrictions e.g. Germany, UK, USA, and US persons.
Die Verbreitung dieses Dokuments und/oder der Verkauf bestimmter Produkte unterliegen Einschränkungen z.B. Deutschland, Großbritannien, USA und US-Personen.
Fax(44-20) 74 18 84 47 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 How has the effectiveness of Zubrin been studied?
Fax(44-20) 74 18 84 47 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 Wie wurde die Wirksamkeit von Zubrin untersucht?The distribution of this document in other jurisdictions may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe, any such restrictions.
Die Verteilung dieses Dokuments in anderen Jurisdiktionen kann gesetzlich beschränkt sein und Personen, die in den Besitz 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 What benefit has Nobilis IB 4-91 shown during the studies?
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 Welchen Nutzen hat Nobilis IB 4-91 in diesen Studien gezeigt?The distribution of this document in or into other jurisdictions may be restricted by law and persons into whose possession this document comes should inform themselves about and observe, any such restrictions.
Die Verteilung dieses Dokuments in anderen Gerichtshoheiten kann durch Gesetz beschränkt sein und Personen, in deren Besitz Fax(44-20) 74 18 86 13 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.
Fax(44-20) 74 18 86 13 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 Das endgültige Gutachten wurde von der Europäischen Kommission am 11/10/2006 in eine Entscheidung umgewandelt.The distribution of this document in Canada, Japan or other jurisdictions may be restricted by law, and persons who come into possession of this publication should find out about any such restrictions and respect them.
Die Verteilung dieses Dokuments in Kanada, Japan oder andere Ge- richtsbarkeiten kann durch Gesetz beschränkt sein und Personen, in deren Besitz Fax(44-20) 74 18 86 13 E-mail: mail@emea. eu. int http://www. emea.eu. int EMEA 2002 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
Fax(44-20) 74 18 86 13 E-mail: mail@emea.eu. int http: //www. emea.eu.int EMEA 2002 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged• Unter den bei der EMEA bereits eingereichten oder erwarteten Anträgen für„ Orphan Drugs“ befinden sich Arzneimittel für.The distribution of this document may be restricted by law in certain jurisdictions and persons into whose possession any document or other information referred to herein come should inform themselves about and observe any such restrictions.
Die Verbreitung dieses Dokuments ist in einigen Ländern möglicherweise nur eingeschränkt zulässig und Personen, die in den Besitz eines 
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 responding to them.
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 Immunsystems und die Entwicklung der mit AIDS verbundenen Infektionen und Erkrankungen hinauszögern.The distribution of this document may be restricted by law in certain jurisdictions and persons into whose possession any document or other information referred to herein come should inform themselves about and observe any such restrictions.
Die Verbreitung dieses Dokuments ist in einigen Ländern möglicherweise nur eingeschränkt zulässig und Personen, die in den Besitz eines in Fax(44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http://www. emea. europa.eu©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Easotic shown during the studies?
Fax(44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: //www. emea. europa.eu ©EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged der Studie an Hunden mit akuten oder wiederkehrenden bakteriellen bzw?EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged welche Dosis erforderlich ist.Fax(44-20) 74 18 84 46 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 How has Ibaflin been studied?
Fax(44-20) 74 18 84 46 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 Fluorchinolon-Gruppe resistent sind, sind auch gegen andere Mitglieder dieser Gruppe resistent?EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged der Studie an Hunden mit akuten oder wiederkehrenden bakteriellen bzw.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 What benefit has TRAVATAN shown during the studies?
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,?Fax(44-20) 74 18 86 13 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 Administration giving a detailed dosing recommendation for antibiotics, in accordance with“ Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 15 September 2005.
Fax(44-20) 74 18 86 13 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 In seiner Sitzung im September 2005 war der CHMP angesichts der insgesamt vorgelegten Daten und der wissenschaftlichen Erörterung innerhalb des Ausschusses der Ansicht, dass das Nutzen-Risiko- Verhältnis für Lansoprazol-ratiopharm günstig ist.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 the day; and this gives Actraphane a longer duration of action.
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 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 The CHMP gave a positive opinion on 21 September 2006 recommending the harmonisation of the SPC.
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 Die zu Beginn des Verfahrens festgestellten Meinungsverschiedenheiten wurden ausgeräumt.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*Note: the information given in this document and Annexes reflect only the CHMP Opinion dated 27 April 2006.
Fax(44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.euEMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Das Verzeichnis der betroffenen Bezeichnungen des Arzneimittels ist in Anhang I enthalten.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 What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
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. 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 bleeding episodes that occurred and rated BeneFIX' s effectiveness using a four-point scale“ excellent”,“ good”,“ moderate”.
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 What were the major concerns which led the CHMP to recommend the refusal of the marketing authorisation?
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 Was waren die größten Bedenken, die den CHMP zu der Empfehlung veranlasst haben, die Genehmigung für das Inverkehrbringen zu versagen?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 the response of the patient, with doses ranging from 2 to 20 million IU per square metre of body surface area.
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 dreimal wöchentlich(jeden zweiten Tag) verabreicht, kann jedoch bei einigen Krankheiten(CML und Melanom) auch häufiger gegeben werden.
