`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`Canada.ca
`
`>
`
`Health Canada
`
`>
`
`Drugs & Health Products
`
`>
`
`Drug Products
`
`>
`
`>
`
`Drug Product Database
` Drug Product Database online query
`Product information
`From Health Canada
`New search
`
`The product monograph is developed by a drug sponsor according
`to guidelines published by Health Canada that provide direction on
`the content and format. The veterinary labelling is developed by the
`drug sponsor according to the Food and Drug Regulations. While
`Health Canada reviews the product monograph or the veterinary
`labelling as part of the drug review process, it remains the
`responsibility of the drug sponsor to ensure that the product
`monograph or the veterinary labelling is complete and accurate.
`
`Current status:
`Marketed
`Current status date:
`2021-03-10
`Original market date: 1
`2021-03-10
`Product name:
`
`1 of 6
`
`CELGENE 2056
`APOTEX v. CELGENE
`IPR2023-00512
`
`8/14/2023, 10:28 AM
`
`
`
`Product information
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`ONUREG
`Help on accessing alternative formats, such as Portable Document
`Format (PDF), Microsoft Word and PowerPoint (PPT) �les, can be obtained
`in the alternate format help section.
`DIN:
`02510197
`Product Monograph/Veterinary Labelling:
`Date: 2021-01-04
` Product monograph/Veterinary Labelling (PDF version ~
`175K)
`Company:
`CELGENE INC
`300 2344 Alfred-Nobel Boulevard
`Saint-Laurent
`Quebec
`Canada H4S 0A4
`Class:
`Human
`Dosage form(s):
`Tablet
`Route(s) of administration:
`Oral
`Number of active ingredient(s):
`1
`
`2 of 6
`
`8/14/2023, 10:28 AM
`
`
`
`Product information
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`Schedule(s):
`Prescription
`
`American Hospital Formulary Service (AHFS): 3
`10:00.00
`Anatomical Therapeutic Chemical (ATC): 4
`L01BC07 AZACITIDINE
`Active ingredient group (AIG) number: 5
`0152665002
`
`List of active ingredient(s)
`Active ingredient(s)
`AZACITIDINE
`
`Strength
`200 MG
`
`New search
`
`Footnotes
`
`Same active ingredient group
`number
`
`1
`
`The earliest marketed date recorded in the Drug Product
`Database.
`
`3 of 6
`
`8/14/2023, 10:28 AM
`
`
`
`Product information
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`3
`
`4
`
`5
`
`The American Hospital Formulary Service permits an easy
`review of information on a group of drugs with similar activities
`and uses and allows the reader to determine quickly the
`similarities and di�erences among drugs within a group.
`AHFS® Pharmacologic/Therapeutic Classi�cation© used with
`permission. © 2022, the American Society of Health-System
`Pharmacists, Inc. (ASHP). The Data is a part of the AHFS Drug
`Information®; ASHP is not responsible for the accuracy of
`transpositions from the original context.
`
`The purpose of the World Health Organization (WHO)
`Anatomical Therapeutic Chemical (ATC) classi�cation system is
`to be used as a tool for drug utilization research in order to
`improve quality of drug use. Drugs are divided into di�erent
`groups according to the organ or system on which they act and
`their chemical, pharmacological and therapeutical properties.
`
`The AIG number is a 10 digit number that identi�es products
`that have the same active ingredient(s) and ingredient
`strength(s). The AIG is comprised of three portions:
`• the �rst portion (2 digits) identi�es the number of active
`ingredients,
`• the second portion (5 digits) identi�es the unique groups
`of active ingredients(s),
`• the last portion (3 digits) identi�es the active ingredient
`group strength. The strength group has a tolerance of -2%
`to +10%.
`
`4 of 6
`
`8/14/2023, 10:28 AM
`
`
`
`Product information
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`Application information
`Search tips
`Drug product database terminology
`Drug product database data extracts
`
`Related information
`MedE�ect Canada
`Adverse drug reaction - veterinary drugs
`Notice of compliance database
`Licensed natural health products database
`
`Contact us
`Content support
`Technical support
`
`Version 4.0.1
`
`5 of 6
`
`8/14/2023, 10:28 AM
`
`
`
`Product information
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`Date modi�ed: 2023-05-25
`
`6 of 6
`
`8/14/2023, 10:28 AM
`
`