Review decisions

Showing 410 results of 633 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00555
Product Type: Drug
Control Number: 220405
Manufacturer: Sanofi Genzyme, A Division of Sanofi-aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-03
Decision / Authorization Date: 2019-09-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00546
Product Type: Drug
Control Number: 220321
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-20
Decision / Authorization Date: 2019-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00545
Product Type: Drug
Control Number: 220039
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-10
Decision / Authorization Date: 2019-08-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00542
Product Type: Drug
Control Number: 220278
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-09-19
Decision / Authorization Date: 2019-08-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00539
Product Type: Drug
Control Number: 211993
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-12-11
Decision / Authorization Date: 2019-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00540
Product Type: Drug
Control Number: 219716
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-08-29
Decision / Authorization Date: 2019-08-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00576
Product Type: Drug
Control Number: 219500
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-08-24
Decision / Authorization Date: 2019-08-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00537
Product Type: Drug
Control Number: 219669
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-08-30
Decision / Authorization Date: 2019-07-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00624
Product Type: Drug
Control Number: 219784
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-04
Decision / Authorization Date: 2019-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00535
Product Type: Drug
Control Number: 219700
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-08-30
Decision / Authorization Date: 2019-07-04