Please note, this monograph also covers the acetate form of leuprorelin (CAS RN 74381-53-6). Leuprorelin, also called leuprolide, is a synthetic nonapeptide analogue of gonadotropin-releasing hormone. Leuprolide binds to and activates gonadotropin-releasing hormone (GnRH) receptors. Leuprolide is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions. It is also indicated concomitantly with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary. Leuprolide is also indicated for the treatment of children with central precocious puberty (CPP) and for the palliative treatment of advanced prostate cancer.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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