Esmya (ulipristal acetate 5 mg): Withdrawal of product registration

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Description

The National Pharmaceutical Regulatory Agency (NPRA) would like to inform healthcare professionals regarding the withdrawal of product registration of Esmya 5 mg tablet (ulipristal acetate) [MAL15025044ACZ] by Zuellig Pharma Sdn. Bhd. in Malaysia and worldwide.

In April 2020, Esmya products have been recalled from the market in response to new safety concerns on the risk of liver injury associated with Esmya as highlighted by the European Medicines Agency (EMA) pending a safety review. Cases of serious liver injury leading to liver transplantation following exposure to ulipristal acetate had occurred despite the implementation of risk minimisation measures since 2018.

The product registration holder decided to withdraw the product registration of Esmya based on the final recommendations following EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) review process in September 2020. Therefore, Esmya will no longer be available and women previously receiving Esmya should be advised on alternative therapy.

In Malaysia, Esmya was the only registered product containing ulipristal acetate 5 mg. Esmya was approved for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

On 16th November 2020, NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Zuellig Pharma Sdn. Bhd. to inform on this withdrawal of registration. For further information, please contact your local sales person for a copy of the DHPC.

[Note: This risk is not related to another product containing ulipristal acetate, Ella Tablet 30 mg (MAL12035079ACZ), which is used for emergency contraception.]

 

Disclaimer

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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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.

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  • Last Modified: Friday 15 October 2021, 15:58:04.
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