OEL Fastrac Catalog

Norgestimate is the progestogenic component of combined oral contraceptives (COC) indicated for the prevention of pregnancy. The combination of norgestimate with ethinyl estradiol is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age. Norgestimate is also used in combination with estradiol to treat the symptoms of menopause. Norgestimate, a synthetic form of the female sex hormone progesterone, binds to androgen and progestogen receptors on target cells in the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary gland. Once bound, norgestimate will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory luteinizing hormone (LH) surge. COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Changes in cervical mucus and the endometrium inhibit sperm penetration and reduce the likelihood of implantation.

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.

Why do you need this OEL Fastrac monograph?

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:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Norgestimate, just click the ADD TO CART button.

HBEL

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