Locabiotal® Solution (fusafungine): Withdrawal of registration following European Medicines Agency’s benefit-risk assessment

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Date: 18 May 2016

 

Description:

Locabiotal® Solution (oromucosal/nasal spray containing fusafungine) will no longer be available in Malaysia and worldwide following a review which concluded that the benefits of this medicine no longer outweigh the risks. Fusafungine-use has been linked to rare but serious cases of hypersensitivity, including allergic reactions and life-threatening anaphylactic reactions, and there is limited evidence of beneficial effects. Patients should be advised about alternative therapy. A product recall is being conducted at all points of sale (e.g. hospitals, pharmacies, clinics, specialist centres). For further details, please refer to the Direct Healthcare Professional Communication (DHPC) issued by Servier Malaysia Sdn. Bhd., in agreement with NPCB.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 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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