Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk

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About

This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date.

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Key facts

Medicine name
  • Esmya
  • Ulipristal Acetate Gedeon Richter
Active substance
ulipristal acetate
Therapeutic area (MeSH)
Leiomyoma
Procedure number
EMEA/H/A-31/1496
Regulatory outcome
Suspension
DHPC type
Interim measures
Referral name
Ulipristal acetate 5mg medicinal products
Dissemination date
23/03/2020

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