Review decisions

Showing 2180 results of 2627 total
Regulatory Decision Summary for XIGDUO
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00175
Product Type: Drug
Control Number: 175649
DIN(s): 02449935, 02449943
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-12-22
Decision / Authorization Date: 2015-12-10
Regulatory Decision Summary for EYLEA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00019
Product Type: Drug
Control Number: 180861
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-19
Decision / Authorization Date: 2015-12-10
Summary Safety Review - Over-the-counter topical acne products containing either BENZOYL PEROXIDE or SALICYLIC ACID - Assessing the potential risk of serious allergic reactions (serious hypersensitivity reactions)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00006
Issued / Original Publication Date: 2015-12-10
Regulatory Decision Summary for STELARA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00046
Product Type: Drug
Control Number: 180654
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-15
Decision / Authorization Date: 2015-12-10
Regulatory Decision Summary for FORXIGA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00078
Product Type: Drug
Control Number: 180845
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-19
Decision / Authorization Date: 2015-12-09
Summary Safety Review - CODEINE PRESCRIPTION PRODUCTS Indicated for Cough - Further Assessing the Risk of Serious Breathing Problems in Children and Adolescents
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00007
Issued / Original Publication Date: 2015-12-09
Summary Safety Review - GARDASIL (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) - Assessing General Safety with a Focus on Autoimmune and Cardiovascular Diseases
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00008
Issued / Original Publication Date: 2015-12-09
Summary Basis of Decision for Rekovelle
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00393
Product Type: Drug
Control Number: 188743
DIN(s): 02487462, 02487470, 02487489
Manufacturer: Ferring Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-09
Issued / Original Publication Date: 2018-06-02
Decision / Authorization Date: 2018-03-22
Updated Date: 2024-11-04
Regulatory Decision Summary for GRASTOFIL
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00080
Product Type: Drug
Control Number: 156897
DIN(s): 02441489
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2012-07-16
Decision / Authorization Date: 2015-12-07
Regulatory Decision Summary for BETEFLAM
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00138
Product Type: Drug
Control Number: 180711
DIN(s): 02449773
Manufacturer: Cipher Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-12-16
Decision / Authorization Date: 2015-12-04

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