Review decisions

Showing 1820 results of 2627 total
Regulatory Decision Summary for Lipiodol Ultra Fluid
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00278
Product Type: Drug
Control Number: 196107
DIN(s): 00386685
Manufacturer: Guerbet
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-07-25
Decision / Authorization Date: 2017-07-13
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00269
Product Type: Drug
Control Number: 198839
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-10-03
Decision / Authorization Date: 2017-07-12
Regulatory Decision Summary for Aggrastat
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00274
Product Type: Drug
Control Number: 186324
Manufacturer: Correvio (UK) Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-07-27
Decision / Authorization Date: 2017-07-12
Regulatory Decision Summary for Defitelio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00270
Product Type: Drug
Control Number: 200808
DIN(s): 02465981
Manufacturer: Jazz Pharmaceuticals Ireland Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-07-11
Decision / Authorization Date: 2017-07-10
Summary Safety Review - Amino-acid solutions for parenteral nutrition - Assessing the potential risk of death in premature infants when the solutions are not protected from light
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00169
Issued / Original Publication Date: 2017-07-06
Regulatory Decision Summary for Prolastin-C
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00271
Product Type: Drug
Control Number: 205855
Manufacturer: Grifols Therapeutics Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-23
Decision / Authorization Date: 2017-06-30
Regulatory Decision Summary for Octasa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00862
Product Type: Drug
Control Number: 194646
DIN(s): 02465752
Manufacturer: Tillotts Pharma AG
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-05-12
Decision / Authorization Date: 2017-06-30
Summary Safety Review - Hydroxyethyl starch (voluven and volulyte) - Assessing the Potential Risk of Acute Kidney Injury in Non-Critically Ill Patients
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00168
Issued / Original Publication Date: 2017-06-30
Regulatory Decision Summary for Spinraza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00268
Product Type: Drug
Control Number: 200070
DIN(s): 02465663
Manufacturer: Biogen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-11-10
Decision / Authorization Date: 2017-06-29
Summary Safety Review - AUBAGIO (teriflunomide) - Assessing the potential risk of inflammation of the colon (colitis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00167
Issued / Original Publication Date: 2017-06-28

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