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Regulation of the Federal Minister for Health and Women concerning the information of the specialist and use information for medicinal products for the treatment of hormonal replacement therapy in peri-and postmenopausal women
On the basis of § 5 of the German Medicines Act, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I No 12/2003, shall be assigned:
§ 1. Systemically applicable oestrogen-containing proprietary medicinal products and tibolone-containing medicinal products for hormone substitution in peri-and postmenopausal women may be used in the field of osteoporosis prevention in the section "Application areas" of the subject. and package leaflet shall contain only the following or the same information:
| " Second choice for the prevention of osteoporosis in postmenopausal women with a high risk of future fractures, if these women either do not bear other medicines for the prevention of osteoporosis or if these medicines are used in the case of these women are contraindicated. " |
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§ 2. All information in subject and use information which contradict the information in § 1 has to be dispensed with.
§ 3. Until 31 March 2004, the notifications required for the inclusion of the data in accordance with this Regulation shall be submitted in accordance with Section 24 of the Medicines Act. Medicinal products which do not comply with this Regulation may not be placed on the market by the marketing authorisation holder as from 1 April 2004. Medicinal products which do not comply with this Regulation may be made by pharmacies until the end of 30 September 2004.
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