Information Specialist And Use Information On Medicinal Products Of Hormone Replacement Therapy In Peri - And Postmenopausal Women

Original Language Title: Angaben der Fach- und Gebrauchsinformation bei Arzneispezialitäten zur Hormonersatztherapie bei peri- und postmenopausalen Frauen

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48. Regulation of the Federal Minister for health and women regarding information specialist and use information on medicinal products of hormone replacement therapy in peri - and postmenopausal women on the basis of section 5 of the medicines Act, Federal Law Gazette No. 185/1983, as last amended by Federal Law Gazette I no. 12/2003, is prescribed:

§ Should contain in terms of osteoporosis prevention in exclusively following the section "Applications" of specialist and use information or identical information to apply 1 systemic estrogen-containing medicinal products and Tibolone-containing medicinal products of hormone substitution in peri - and postmenopausal women:

"Means of second choice for the prevention of osteoporosis in postmenopausal women at high risk of future fractures, if these women either do not take other medicines for the prevention of osteoporosis, or if these are contraindicated in these women."

§ 2. All instructions in technical and use information, which contradict the information in section 1, have to be omitted.

§ 3. Until March 31, 2004, you are the required reports in accordance with § 24 of the German medicines Act to submit for inclusion of the information in accordance with this regulation. Medicinal products which do not comply with this regulation, may no longer be placed from 1 April 2004 by the marketing authorisation holder in traffic. Medicinal products which do not comply with this regulation, may be placed by pharmacies until the expiry of the September 30, 2004.