Health

Submissions Under Review

This is a list of certain drug submissions currently under review. The Submissions Under Review list includes the medicinal ingredient(s) and therapeutic area.

 
 

Regulatory decision summary for ACARIZAX (Control number 195186)

Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization.

 
 

Summary Basis of Decision for REXULTI

Health Canada Summary Basis of Decision 2017/05/12. Rexulti, brexpiprazole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, tablets, Otsuka Pharmaceutical Co., Ltd.. Submission Control Number 192684

 
 

Regulatory decision summary for KUVAN (Control number 186959)

Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization.

 
 

Regulatory decision summary for INVOKANA (Control number 194762)

Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization.

 
 

Post-Authorization ActivityTable for OPDIVO

Health Canada Post-Authorization Activity Table 2017/05/10. Opdivo, 40 mg/vial, 100 mg/vial, nivolumab, solution, Bristol-Myers Squibb Canada.

 
 

Regulatory decision summary for YERVOY (Control number 202533)

Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization.

 
 

Post-Authorization Activity Table for VIMIZIM

Health Canada Post-Authorization Activity Table 2017/04/13. Vimizim, 1 mg/mL, elosulfase alfa, solution, BioMarin International Limite

 
 

Post-Authorization Activity Table for LENVIMA

Health Canada Post-Authorization Activity Table 2017/05/05. Lenvima, lenvatinib, 4 mg and 10 mg capsules, Eisai Limited

 
 

Regulatory decision summary for PRIMAQUINE (Control number 196046)

Regulatory Decision Summaries (RDSs) explain Health Canada’s decisions for certain health products seeking market authorization.

 
 
 
 

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