Review decisions

Showing 30 results of 73 total
Regulatory Decision Summary for Spravato
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00895
Product Type: Drug
Control Number: 244338
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-23
Decision / Authorization Date: 2021-09-02
Regulatory Decision Summary for Ponvory
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00838
Product Type: Drug
Control Number: 239537
DIN(s): 02515474, 02515482
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-05-15
Decision / Authorization Date: 2021-04-28
Regulatory Decision Summary for Darzalex SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00791
Product Type: Drug
Control Number: 244119
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-18
Decision / Authorization Date: 2021-04-12
Regulatory Decision Summary for Janssen COVID-19 Vaccine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00779
Product Type: Drug
Control Number: 246758
DIN(s): 02513153
Manufacturer: Janssen Inc.
Submission Type: Application filed under section 3 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-11-30
Decision / Authorization Date: 2021-03-05
Summary Basis of Decision for Jcovden (previously the Janssen COVID-19 Vaccine)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00522
Product Type: Drug
Control Number: 246758
DIN(s): 02513153
Manufacturer: Janssen Inc.
Submission Type: Application for authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-11-30
Issued / Original Publication Date: 2021-03-19
Decision / Authorization Date: 2021-03-05
Updated Date: 2024-01-19
Regulatory Decision Summary for Darzalex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00732
Product Type: Drug
Control Number: 234407
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-12
Decision / Authorization Date: 2020-11-17
Regulatory Decision Summary for Tremfya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00697
Product Type: Drug
Control Number: 232124
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-09-30
Decision / Authorization Date: 2020-09-04
Regulatory Decision Summary for Darzalex SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00690
Product Type: Drug
Control Number: 231031
DIN(s): 02502712
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-22
Decision / Authorization Date: 2020-07-29
Regulatory Decision Summary for Stelara
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00665
Product Type: Drug
Control Number: 230279
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-07-31
Decision / Authorization Date: 2020-06-16
Regulatory Decision Summary for Spravato
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00738
Product Type: Drug
Control Number: 222855
DIN(s): 02499290
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-12-10
Decision / Authorization Date: 2020-05-20

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