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haltlichen Änderungen vorgenommen werden, da die Freigabe der Gebrauchsanweisung Gegenstand
der Beurteilung im Rahmen der Sonderzulassung ist.
Wir empfehlen Ihnen, in der Gebrauchsanweisung die Kontaktdaten des deutschen Vertreibers inklu-
sive einer Telefonnummer für Rückfragen durch Anwenderinnen und Anwender anzugeben.
Wir empfehlen Ihnen, in der Kennzeichnung und in Gebrauchsanweisung nicht das Datum der Befris-
tung dieser Sonderzulassung anzugeben, da dieses Datum als Verfallsdatum missinterpretiert werden
kann.
Rechtsbehelfsbelehrung:
Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch beim Bundesin-
stitut für Arzneimittel und Medizinprodukte in Bonn erhoben werden.
Mit freundlichen Grüßen
Im Auftrag
Kerstin Brandenburg
Dieser Bescheid enthält in Übereinstimmung mit § 37 Absatz 3 Satz 1 Verwaltungsverfahrensgesetz nur eine Namenswieder-
gabe und keine Unterschrift.
16


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