Review decisions

Showing 1990 results of 2627 total
Summary Safety Review - Interferon beta products - Assessing the Potential Risk of Pulmonary Arterial Hypertension
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00127
Issued / Original Publication Date: 2016-11-02
Updated Date: 2016-11-30
Regulatory Decision Summary for PAZEO
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00251
Product Type: Drug
Control Number: 189463
DIN(s): 02458551
Manufacturer: Alcon Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-11-13
Decision / Authorization Date: 2016-10-28
Summary Basis of Decision for Xiidra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00383
Product Type: Drug
Control Number: 199810
DIN(s): 02471027
Manufacturer: Shire Pharma Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-10-28
Issued / Original Publication Date: 2018-02-20
Decision / Authorization Date: 2017-12-22
Updated Date: 2025-07-24
Summary Safety Review - Cervarix (Human Papillomavirus vaccine Types 16 and 18 [Recombinant, AS04 adjuvanted]) - Assessing the Potential Risk of a Condition in which the body's defense system damages nerves (Guillain-Barré Syndrome)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00122
Issued / Original Publication Date: 2016-10-27
Summary Safety Review - Havrix (hepatitis A vaccine, inactivated) - Assessing the Potential Risk of Decreased Amounts of Blood Platelets (thrombocytopenia)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00125
Issued / Original Publication Date: 2016-10-27
Regulatory Decision Summary for OPDIVO
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00172
Product Type: Drug
Control Number: 189307
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-11-05
Decision / Authorization Date: 2016-10-26
Summary Safety Review - Tumour Necrosis Factor (TNF) alpha blockers (SIMPONI and CIMZIA) - Assessing the Potential Risk of Liver Inflammation (Autoimmune Hepatitis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00140
Issued / Original Publication Date: 2016-10-25
Summary Safety Review - Levetiracetam and Methotrexate - Assessing the Potential Risk of Drug-Drug Interaction
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00128
Issued / Original Publication Date: 2016-10-24
Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Urinary Retention
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00121
Issued / Original Publication Date: 2016-10-21
Summary Safety Review - Incretin-Based Therapies - Assessing the Potential Risk of Pancreatic Cancer
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00126
Issued / Original Publication Date: 2016-10-21

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