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21 March 2013 EMA/462277/2013 Committee for Medicinal Products for Human Use (CHMP)CHMP extension of indication variation assessment reportMabTheraProcedure no. EMEA/H/C/000165/II/0079Marketing authorization
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What is chmp extension of indication?
The CHMP extension of indication is a process in which a company seeks to expand the approved use of a medicinal product to include additional indications.
Who is required to file chmp extension of indication?
The marketing authorization holder of the medicinal product is required to file for a CHMP extension of indication.
How to fill out chmp extension of indication?
The CHMP extension of indication application must be filled out and submitted to the regulatory authorities following their specific guidelines and requirements.
What is the purpose of chmp extension of indication?
The purpose of a CHMP extension of indication is to allow companies to provide additional evidence supporting the safety and efficacy of the medicinal product for additional indications.
What information must be reported on chmp extension of indication?
The CHMP extension of indication application must include data from clinical studies, pharmacovigilance reports, and any other relevant information supporting the proposed new indication.
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