Tamoxifen: mimořádná možnost individuální přípravy z neregistrovaných léčivých přípravků v rámci zvláštního léčebného programu

Tamoxifen is available through a special treatment program that enables individual preparation of unregistered medicinal products in pharmacies. Applicants for the program must provide detailed information about the product including name, strength, pharmaceutical form, number of tablets per package, identification data, and distribution information. Doctors may prescribe tamoxifen as the registered product Tamoxifen Ebewe, products from the specific program, or as an individually prepared medicinal product containing 10 mg or 20 mg. Patients may receive quantities corresponding to a maximum of two months of treatment in pharmacies. Pharmacies may only prepare from unregistered products approved by the ministry and must not damage primary packaging. New packages must contain a label with the product name, strength, patient identification, preparation date, and storage conditions. The pharmacy is obliged to provide patient information in written form together with the product.