Review decisions

Showing 1780 results of 2627 total
Regulatory Decision Summary for Panzyga
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00287
Product Type: Drug
Control Number: 201326
Manufacturer: Octapharma Pharmazeutika Produktionsges m.b.H.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-01-23
Decision / Authorization Date: 2017-10-04
Regulatory Decision Summary for Akynzeo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00324
Product Type: Drug
Control Number: 196495
DIN(s): 02468735
Manufacturer: Purdue Pharma
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-13
Decision / Authorization Date: 2017-09-28
Summary Basis of Decision for Orilissa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00426
Product Type: Drug
Control Number: 209513
DIN(s): 02481332, 02481340
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-09-22
Issued / Original Publication Date: 2019-04-15
Decision / Authorization Date: 2018-10-05
Updated Date: 2024-05-21
Regulatory Decision Summary for Lanvis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00290
Product Type: Drug
Control Number: 199259
Manufacturer: Aspen Pharmacare Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-10-13
Decision / Authorization Date: 2017-09-21
Summary Safety Review - Atypical antipsychotics - Assessing the potential risk of sleep walking and sleep-related eating disorder
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00176
Issued / Original Publication Date: 2017-09-21
Summary Safety Review - Birth control hormone systems (intrauterine) - Assessing the potential risk of less breast milk production
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00177
Issued / Original Publication Date: 2017-09-21
Regulatory Decision Summary for Stivarga
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00403
Product Type: Drug
Control Number: 203322
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-02-28
Decision / Authorization Date: 2017-09-18
Regulatory Decision Summary for Epclusa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00299
Product Type: Drug
Control Number: 199753
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-10-27
Decision / Authorization Date: 2017-09-14
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00286
Product Type: Drug
Control Number: 203157
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-03-28
Decision / Authorization Date: 2017-09-13
Regulatory Decision Summary for Lenvima
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00288
Product Type: Drug
Control Number: 197794
DIN(s): 02468220, 02468239
Manufacturer: Eisai Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-08-26
Decision / Authorization Date: 2017-09-13

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