Avastin

France has enacted new rules on the off-label use of medicines.  A new Decree amending the rules on Temporary Recommendations for Use (“RTU”) established pursuant to Article L5121-12-1 of the French Public Health Code (“PHC”) was published on 31 December 2014 (the “Decree”).  This Decree follows the adoption of the amended social security budget bill in August last year, which introduced revisions to the preexisting Article L5121-12-1 PHC.  According to the legislative history of the law, this change may have been intended to allow off-label prescription of Roche’s cancer drug Avastin® after reformulation to treat the eye condition age-related macular degeneration, instead of the Novartis product Lucentis®, which is specifically developed and approved for that indication.
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