Cellcept® (mycophenolate mofetil): Teratogenic risk – important new pregnancy prevention advice for women and men

Kadar pengguna: 1 / 5

bintang aktifBintang tidak aktifBintang tidak aktifBintang tidak aktifBintang tidak aktif

Date: 14 December 2015



New contraindications have been added to the prescribing information for Cellcept® (mycophenolate mofetil) related to the teratogenic risk. Cellcept® is contraindicated during pregnancy, in women of childbearing potential not using highly effective contraceptive methods, and in women who are breastfeeding. These recommendations were made following a cumulative review of birth defects which showed that mycophenolate is a powerful human teratogen with increased rate of spontaneous abortions or malformations compared to other immunosuppressants. A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals of these new contraindications and provide further advice on pregnancy testing as well as contraceptive use for women and men. Please refer to the DHPC issued by Roche (Malaysia) Sdn. Bhd. for further information.

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400



Image   Image   Image   Image  


The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Rabu 19 Jun 2024, 12:08:24.
© Copyright 2018 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA


Menu Utama