Published on
Updated
Reading 2 mins.
in collaboration with
Dr. Yves Dour (pharmacist)
Medical validation:
July 26, 2022
On Friday June 17, the credits repertoire was enriched with 8 new groups. Discover the new drugs that can be substituted by your pharmacist.
8 new generic groups
In early June, the National Medicines Safety Agency (ANSM) issued several marketing authorizations (AMM). The processing operations concerned have been entered in the directory of generic groups and have been the subject of an official publication on the ANSM website.
“These new groups of generics, which are rapidly arriving on the market, make it possible to make economies of scale on molecules. This phenomenon will therefore become more and more frequent.“, says Dr. Dour.
These are the following 8 new groups:
- an AMIFAMPRIDINE 10 mg tablet group, whose referent is the antimyasthenic FIRDAPSE 10 mg tablet (indicated in the treatment of Lambert-Eaton Syndrome);
- two groups CHOLECALCIFEROL oral solution in ampoule, corresponding to dosages of 80,000 IU and 200,000 IU, with ZYMAD 80,000 IU and ZYMAD 200,000 IU as referents (indicated in the treatment of vitamin D deficiency);
- a METOPIMAZINE 7.5 mg oral lyophilisate group (reference: VOGALENE LYOC 7.5 mg oral lyophilisate) and a METOPIMAZINE 7.5 mg WITHOUT SUGAR oral lyophilisate sweetened with aspartame group (reference: VOGALIB). These two specialties are indicated in the treatment of nausea and vomiting;
- two PIRFÉNIDONE tablet groups corresponding to the 267 mg and 801 mg dosages, the referents of which are ESBRIET 267 mg and ESBRIET 801 mg tablet (indicated in the treatment of idiopathic pulmonary fibrosis);
- a group SAPROPTERINE 100 mg tablet for oral solution, in the referent is the hospital specialty KUVA (indicated in the treatment of phenylketonuria and tetrahydrobiopterin deficiency).
All medicinal products must be subject to a marketing authorization (AMM) before being marketed.
To obtain it, the pharmaceutical company that manufactures the drug must compile a file containing all the scientific results obtained during the development of the latter (the chemical quality of the finished product, the manufacturing processes of the substance, the adverse effects, etc.) and preclinical and clinical studies (in humans and animals).
The company then submits this dossier to the competent health authorities, which may be national (National Agency for the Safety of Medicines and Health Products – ANSM) or European (the European Medicines Agency – EMA) .
Authorization is only issued when the dossier is complete and provides proof of the quality, safety and efficacy of the drug, with a favorable benefit/risk ratio.
Once a drug is put on the market, its impact is studied on a very large population to monitor its potential adverse effects. This is pharmacovigilance.