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Your innovator company's new product PrAMIGOS (amikacin sulphate) 10 mg tablets isapproved in Canada since November 14, 2016, as a small molecule antibiotic. These tabletsare
Your innovator company's new product PrAMIGOS (amikacin sulphate) 10 mg tablets isapproved in Canada since November 14, 2016, as a small molecule antibiotic. These tabletsare packaged in plastic bottles.On January 21, 2024, your global regulatory team informs you that the scientific team isconsidering tightening of the storage conditions of the AMIGOS bottles.Current storage condition: 1525CProposed storage condition: 1520CRationale for the update provided by the global team: Stability Testing results support theproposed change.No other changes to the Drug Product or Drug Substance.The global colleague requests your feedback on the Canadian assessment of the following. What type of Post-Noc change is that? How long will it take for Health Canada to approve this change? would it be it falls under C&M only SNDS, its total target timeline (performance standard) is 235 calendar days? or would be under SNDS Clinical or Non-Clinical data only with the target timeline (performance standard) of 155 calendar days
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