throbber
3/29/23, 2:23 PM
`
`Product information
`
`>
`
`>
`
`Drug Products
`
`>
`
`>
`
`>
`
`Canada.ca
` Drugs & Health Products
` Health Canada
` Drug Product Database online query
`Drug Product Database
`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:
`
`CELGENE 2006
`APOTEX v. CELGENE
`IPR2023-00512
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`1/5
`
`

`

`3/29/23, 2:23 PM
`
`Product information
`
`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 S
`
`chedule(s):
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`2/5
`
`

`

`3/29/23, 2:23 PM
`
`Prescription
`
`Product information
`
` 
`
`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
`
`Same active ingredient group
`number
`
`Footnotes
`1
`
`The earliest marketed date recorded in the Drug Product
`Database.
`
`4
`
`The purpose of the World Health Organization (WHO) Anatomical
`Therapeutic Chemical (ATC) classication system is to be used as
`a tool for drug utilization research in order to improve quality of
`drug use. Drugs are divided into dierent groups according to
`the organ or system on which they act and their chemical,
`pharmacological and therapeutical properties.
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`3/5
`
`

`

`3/29/23, 2:23 PM
`
`5
`
`Product information
`
`The AIG number is a 10 digit number that identies products that
`have the same active ingredient(s) and ingredient strength(s). The
`AIG is comprised of three portions:
`the rst portion (2 digits) identies the number of active
`ingredients,
`the second portion (5 digits) identies the unique groups of
`active ingredients(s),
`the last portion (3 digits) identies the active ingredient
`group strength. The strength group has a tolerance of ‑2% to
`+10%.
`
`Application information
`Search tips
`Drug product database terminology
`Drug product database data extracts
`
`Related information
`MedEect Canada
`Adverse drug reaction - veterinary drugs
`Notice of compliance database
`Licensed natural health products database
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`4/5
`
`

`

`3/29/23, 2:23 PM
`
`Product information
`
`Contact us
`Content support
`Technical support
`
`Version 4.0.0
`
`Date modied: 2023-01-24
`
`https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99943
`
`5/5
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket