Direct Healthcare Professional Communication (DHPC) on Linoladiol N® (Estradiol): risks associated with systemic exposure
2020.02.20
Active substance: estradiol
Dr. August Wolff GmbH & Co. KG Arzneimittel in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) informs that treatment with Linoladiol N® (containing estradiol 100 micrograms/g of cream) should be limited to one single period of up to 4 weeks due to the absence of long-term safety data. Linoladiol N® should not be used in patients who are treated with oral or transdermal HRT products.
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