2023-10-03 11:42:03
Registration in the directory is an essential condition for substitution at the pharmacy.
By decision of September 22, 2023 [1]the National Agency for the Safety of Medicines and Health Products (ANSM) has created three additional groups within the generics directory [2] :
DAPAGLIFLOZIN 10 mg film-coated tablet group: referent: FORXIGA 10 mg film-coated tablet, FORXIGA is indicated in the treatment of type 2 diabetes, heart failure and chronic kidney disease, the generic specialty registered in this group (DAPAGLIFLOZIN VIATRIS) is not marketed to date; DIGOXIN 0.25 mg tablet group: referent: DIGOXIN NATIVELLE 0.25 mg tablet, this medication is indicated in the treatment of heart failure and supraventricular rhythm disorders, the generic specialty registered in this group (DIGOXIN ARROW 0.25 mg) is not currently marketed; DIGOXIN 0.125 mg tablet group: referent: HEMIGOXINE NATIVELLE 0.125 mg tablet, this medication is indicated in the treatment of heart failure and supraventricular rhythm disorders, the generic specialty registered in this group (DIGOXIN ARROW 0.125 mg) is not marketed to date, there are no generic groups for the injectable and oral forms of DIGOXIN.
The inclusion of specialties in the generic directory does not prejudge their effective marketing. This depends in particular on the effective expiration date of the intellectual property rights of the original specialty.
The inclusion of a specialty in the generic directory is an essential condition for substitution during delivery to the pharmacy. The differences in excipient composition between originators and generics are specified in the generics directory.
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