Review decisions

Showing 140 results of 809 total
Regulatory Decision Summary for Ngenla
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00894
Product Type: Drug
Control Number: 246729
DIN(s): 02521679, 02521687
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-24
Decision / Authorization Date: 2021-10-26
Summary Basis of Decision for Elonox/Elonox HP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00632
Product Type: Drug
Control Number: 243026
DIN(s): 02532247, 02532255, 02532263, 02532271, 02532298, 02532301, 02532328
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-10-21
Issued / Original Publication Date: 2023-03-28
Decision / Authorization Date: 2022-10-26
Updated Date: 2025-01-21
Regulatory Decision Summary for JAMP GOSERELIN LA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01085
Product Type: Drug
Control Number: 232286
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-04-14
Decision / Authorization Date: 2021-10-20
Regulatory Decision Summary for Opsynvi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00995
Product Type: Drug
Control Number: 245848
DIN(s): 02521083
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-10-29
Decision / Authorization Date: 2021-10-14
Regulatory Decision Summary for Adtralza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00874
Product Type: Drug
Control Number: 245877
DIN(s): 02521288
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-10-30
Decision / Authorization Date: 2021-10-13
Regulatory Decision Summary for Kirsty
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00876
Product Type: Drug
Control Number: 243229
DIN(s): 02520974, 02520982
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-10-30
Decision / Authorization Date: 2021-10-12
Regulatory Decision Summary for Nypozi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00870
Product Type: Drug
Control Number: 220512
DIN(s): 02520990, 02521008
Manufacturer: Tanvex Biopharma USA Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-01-17
Decision / Authorization Date: 2021-10-08
Regulatory Decision Summary for Stendra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01070
Product Type: Drug
Control Number: 220887
Manufacturer: Acerus Pharmaceuticals Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-03-08
Decision / Authorization Date: 2021-10-05
Regulatory Decision Summary for Bambevi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00864
Product Type: Drug
Control Number: 244450
DIN(s): 02520729, 02520737
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-25
Decision / Authorization Date: 2021-09-23
Regulatory Decision Summary for Bevluma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00892
Product Type: Drug
Control Number: 242395
Manufacturer: Centus Biotherapeutics Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-08-20
Decision / Authorization Date: 2021-09-23

Displaying 131 - 140 of 809 | Page 14 of 81
Report a problem or mistake on this page
Please select all that apply:
Date modified: