10 April 2015
EMA/348171/2015
Pharmacovigilance Risk Assessment Committee (PRAC)
Assessment report
Referral under Article 31 of Directive 2001/83/EC resulting from
pharmacovigilance data
I
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Bekanntmachung
über die Registrierung und Zulassung von Arzneimitteln
vom 22.07.2015
Abwehr von Gefahren durch Arzneimittel, Stufe II
Ibuprofen/Dexibuprofen und kardiovaskuläres Risik
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Annex II
Scientific conclusions and grounds for variation to the terms of the
marketing authorisations
370
Scientific conclusions and grounds for variation to the terms of the
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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union
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12 February 2016
EMA/91073/2016
PRAC recommends that fusafungine nose and mouth
sprays are no longer marketed
Committee had concerns over serious allergic reactions and limited evidence
of ben
15.12.2017
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1 April 2016
EMA/227560/2016
CMDh endorses revocation of authorisations for
fusafungine sprays used to treat airway infections
Medicines to be withdrawn due to serious allergic reactions and limi
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ABTEILUNG Pharmakovigilanz
BEARBEITET VON Birgit Folgmann
TEL
E-MAIL birgit.folgmann@bfarm.de
HAUSANSCHRIFT Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
TEL +49 (0)228 99 307-0
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