Italian Medicines Agency Agenzia Italiana del Farmaco

Notice on commercial availability of haptens for patch tests - Notice on commercial availability of haptens for patch tests

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Notice on commercial availability of haptens for patch tests

Following the reports received regarding the unavailability on the market of some haptens of the Adults and Pediatric Baseline Patch Test Series and Cosmetic Additional Patch Test Series, drafted by the AIFA Working Group on the clinical use of haptens for patch test and published on the Agency's web site, we inform you that

1) CAINA MIX (Benzocaine 5% CAS 94-09-7; Cinchocaine hydrochloride 2.5% CAS 61-12-1; Tetracaine hydrochloride 2.5% CAS 136-47-0) 10%, vas
According to the information provided by the company SmartPractice Europe GmbH it will be produced starting from June 2023.
In case of unavailability of the product with code M-13 manufactured by the company Chemotechnique MB Diagnostics it is possible to use
BENZOCAINA 5%, vas code NA13;
CINCOCAINA CLORIDRATO 2.5%, vas code NA26;
TETRACAINA CLORIDRATO 1.0%, vas code DM229.

2) COMPOSITAE MIX II (Anthemis nobilis flower exctract 1.2% CAS 84649-86-5; Chamomilla recutita flower exctract 1.2% CAS 84082-60-0; Achillea millefolium flower exctract 1% CAS 84082-83-7; Tanacetum vulgare 1% CAS 84961-64-8; Arnica montana flower exctract 0.5% CAS  68990-11-4; Partenolide 0.1% CAS 20554-84-1) 5%, vas
According to the information provided by the company SmartPractice Europe GmbH it will be produced by the end of 2023.
In case of unavailability of the product with code Mx-29A manufactured by the company Chemotechnique MB Diagnostics it is possible to use
COMPOSITAE MIX (Tanacetum vulgare 1% CAS 84961-64-8; Arnica montana flower exctract 0.5% CAS 68990-11-4; Tanacetum parthenium 1% CAS 20554-84-1; Matricaria Chamomilla 2.5% CAS 8002-66-2; Achillea millefolium flower exctract 1% CAS 84082-83-7) 6%, vas code NA25 and 
PARTENOLIDE 0.1%, vas code ST173

3) DL-ALFA TOCOFEROLO ACETATO 10%, vas
According to the information provided by the company SmartPractice Europe GmbH it will be produced starting from January 2024.

4) GALLATI MIX (propyl gallate 0.5% CAS 121-79-9; octyl gallate 0.25% CAS 1034-01-1; dodecyl gallate o lauryl gallate 0.25% CAS 1166-52-5) 1.0%, vas
According to the information provided by the company SmartPractice Europe GmbH it will be produced starting from March 2024.
In case of unavailability of the product with code Mx-28B manufactured by the company Chemotechnique MB Diagnostics it is possible to use
N-PROPILE GALLATO 0.5%, vas code AP104;
OCTIL GALLATO 0.3%, vas code EE352;
DODECIL GALLATO 0.3%, vas code AP91.


Published on: 04 April 2023

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