French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
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In agreement with the Afssaps, the NOVARTIS Santé Familiale laboratory withdraws from the market the 3001 to 3007 included and 4001 the medical device called PRORHINEL Spray solution nasal pressure, following the report of two cases of detachment of the end of the diffuser and of housing in the patient's nostril in either case. Lot 4001A is not affected by this recall.