Verordnung der Bundesministerin für Gesundheit und Frauen betreffend Angaben der Fach- und Gebrauchsinformation bei Arzneispezialitäten zur Hormonersatztherapie bei peri- und postmenopausalen Frauen
48. Verordnung der Bundesministerin für Gesundheit und Frauen betreffend Angaben der Fach- und Gebrauchsinformation bei Arzneispezialitäten zur Hormonersatztherapie bei peri- und postmenopausalen Frauen
Auf Grund des § 5 des Arzneimittelgesetzes, BGBl. Nr. 185/1983, zuletzt geändert durch das Bundesgesetz BGBl. I Nr. 12/2003, wird verordnet:
§ 1. Systemisch anzuwendende Östrogen-haltige Arzneispezialitäten und Tibolon-haltige Arzneispezialitäten zur Hormonsubstitution bei peri- und postmenopausalen Frauen dürfen hinsichtlich einer Osteoporose-Prävention im Abschnitt "Anwendungsgebiete" der Fach- und Gebrauchsinformation ausschließlich folgende oder inhaltsgleiche Angaben enthalten:
"Mittel zweiter Wahl zur Prävention der Osteoporose bei postmenopausalen Frauen mit einem hohen Risiko zukünftiger Frakturen, wenn diese Frauen andere Arzneimittel zur Prävention der Osteoporose entweder nicht vertragen oder wenn diese Arzneimittel bei diesen Frauen kontraindiziert sind." |
§ 2. Alle Hinweise in Fach- und Gebrauchsinformation, die den Angaben in §...
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