Review decisions
Showing 710 results of 1550 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00827
Product Type: Drug
Control Number: 241147
DIN(s): 02334852, 02334860, 02334879
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-06-30
Decision / Authorization Date: 2021-06-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00826
Product Type: Drug
Control Number: 246355
DIN(s): 02516667
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-18
Decision / Authorization Date: 2021-06-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01032
Product Type: Drug
Control Number: 238994
DIN(s): 02516764
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-05
Decision / Authorization Date: 2021-06-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00821
Product Type: Drug
Control Number: 248711
Manufacturer: Pendopharm, Division of Pharmascience Inc.
Submission Type: Application filed under section 3 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2021-01-25
Decision / Authorization Date: 2021-06-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00824
Product Type: Drug
Control Number: 246922
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-04
Decision / Authorization Date: 2021-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00818
Product Type: Drug
Control Number: 243600
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-03
Decision / Authorization Date: 2021-05-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1731596920959
Product Type: Drug
Control Number: 252929
Manufacturer: Celltrion Healthcare Co. Ltd.
Submission Type: New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV)
Date Filed / Submission Date: 2021-05-28
Decision / Authorization Date: 2024-07-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00816
Product Type: Drug
Control Number: 240496
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-06-12
Decision / Authorization Date: 2021-05-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00825
Product Type: Drug
Control Number: 244266
DIN(s): 02516233
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-22
Decision / Authorization Date: 2021-05-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00882
Product Type: Drug
Control Number: 238175
DIN(s): 02516241, 02516268
Manufacturer: Endo Ventures Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-04-06
Decision / Authorization Date: 2021-05-25