Italian Medicines Agency Agenzia Italiana del Farmaco

Annex of AIFA’s Director-General Decision DG 98/2022 of 24 February 2022 - Annex of AIFA’s Director-General Decision DG 98/2022 of 24 February 2022

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Annex of AIFA’s Director-General Decision DG 98/2022 of 24 February 2022

Taking into account the work of the AIFA Working Group on the clinical use of haptens for patch test, established with AIFA decision 134/2022 of 30th March 2022, updated by AIFA decision n. 447/2022 of 18th October 2022, which led to the revision of the SIDAPA Standard series and SIDAPA Additional Cosmetic Series with the drafting of the current Adult Baseline Series, the Pediatric Baseline Series and the Additional Cosmetic Series, which are simultaneously published on the Agency website, it is necessary to update the list of haptens temporarily authorized for marketing attached to the AIFA Decision DG 98/2022, published in the Official Gazette General Series no. 51 of 2-3-2022, in order to make available to patients the haptens necessary for the diagnosis of allergic pathologies, in the absence of alternatives authorized for marketing or ope legis present on the market.

In particular, the haptens admitted to the market are listed in alphabetical order to facilitate the constant updating; each admitted hapten is reported with the commercial code if produced by the companies which have submitted a formal request. It should be noted that for haptens ope legis that are no longer produced, haptens produced by another company have been admitted, where available.


Published on: 23 January 2023

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