Release Notes; Version 20181012
General Notes
The following files will be available as full release files within this version:
- Manufactured Product,
- Non-proprietary Therapeutic Product,
- Therapeutic Moiety,
- Manufactured Product, Non-proprietary Therapeutic Product, Therapeutic Product Relationship,
- Special Groupings,
- Coded Attribute, and
- Device Non-proprietary Therapeutic Product.
The 'Full" release contains one entry for every concept that has ever been released and new content added for that release. New content added for a specific release may at times include “Inactive” content.
NOTE: The “Delta" release which is intended to contain only those concepts that have been added or changed since the previous release will be considered for a future enhancement at a later date.
This release continues to add additional content from the DPD and includes most of the top 250 moieties and approximately 82% of the DPD content in scope for CCDD.
The table below provides the number of concepts within each CCDD file for this release.
October 2018 CCDD Files | Number of Concepts | Types of Changes in this release |
|---|---|---|
| Therapeutic Moiety Full Release | 996 | 129 additions 2 status change from active to inactive |
| Non-proprietary Therapeutic Product Full Release | 3021 | 293 additions (286 for new TMs and 7 for existing TMs) 2 NTP formal name changes (see details regarding the corrections below) 6 status changes (Active to Inactive) 2 status date changes (with no change of status) 2 status change from active to deprecated (see details below) 9 existing deprecated concepts changed status date |
| Manufactured Product Full Release | 9142 | 498 additions (see specific details below)
Formal name changes made:
26 status changes (Active to Inactive) 17 status changes (Inactive to Active) 3 status date changes (no change of status) |
Manufactured Product, Non-proprietary Therapeutic Product, Therapeutic Moiety Relationship | 9141 | Includes concept additions and changes as above Deprecated concepts have been excluded. |
| Device Non-proprietary Therapeutic Product | 3 | no change |
| Special Groupings | 1530 | 27 additions |
| Coded Attributes | 7 | no change |
NTP Changes
The following 2 NTP formal names have been corrected in October without a change made to the NTP code.
ntp_code | New formal name (Oct 2018) | Previous formal name |
9001299 | epinephrine 0.3 mg per 0.3 mL solution for injection syringe | epinephrine 0.3 mg per 0.3 mL solution for injection 0.3 mL syringe |
9001298 | epinephrine 0.15 mg per 0.3 mL solution for injection syringe | epinephrine 0.15 mg per 0.3 mL solution for injection 0.3 mL syringe |
An error in the September release was discovered and included the following in red text:
DIN 02368153 Xgeva 120 mg/1.7 mL vial
MP 02368153 Xgeva 204 mg/1.7 mL syringe
NTP 9012954 denosumab 204 mg/1.7 mL syringe
DIN 02210401 dobutamine 250 mg/20 mL (12.5 mg/mL) vial
NTP 9012961 dobutamine 5000 mg/20 mL vial
MP 02210401 dobutamine 5000 mg/20 mL vial
In order to address the error, 2 NTPs have been deprecated. Please see the details below for NTP changes:
Deprecated ntp_code | Deprecated ntp_formal_name | Resolution | ntp_code | ntp_formal_name |
9012961 | dobutamine (dobutamine hydrochloride) 5000 mg per 20 mL solution for injection vial | Existing concept should be used | 9012960 | dobutamine (dobutamine hydrochloride) 250 mg per 20 mL solution for injection vial |
9012954 | denosumab 204 mg per 1.7 mL solution for injection syringe | New concept replaces deprecated concept | 9013076 | denosumab 120 mg per 1.7 mL solution for injection vial |
MP Changes
The following epinephrine pen products are now available in the CCDD in response to a Health Canada Interim Order (see this link for detail); http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67658a-eng.php?_ga=2.125411529.296953804.1536602522-1664644763.1531238402
| mp_code | mp_formal_name | Comments |
| 02480360 | AUVI-Q (epinephrine 0.15 mg per 0.15 mL solution for injection syringe) KALEO INC | With new NTP for existing TM |
| 02480379 | AUVI-Q (epinephrine 0.3 mg per 0.3 mL solution for injection syringe) KALEO INC | New MP for existing NTP |
The following concepts were changed as a result of content corrections required.
| October Release | September Release | ||
| mp_code | mp_formal_name | mp_code | mp_formal_name |
| 02368153 | XGEVA (denosumab 120 mg per 1.7 mL solution for injection vial) AMGEN CANADA INC | 02368153 | XGEVA (denosumab 204 mg per 1.7 mL solution for injection syringe) AMGEN CANADA INC |
| 02210401 | DOBUTAMINE INJECTION USP (dobutamine (dobutamine hydrochloride) 250 mg per 20 mL solution for injection vial) PFIZER CANADA INC | 02210401 | DOBUTAMINE INJECTION USP (dobutamine (dobutamine hydrochloride) 5000 mg per 20 mL solution for injection vial) PFIZER CANADA INC |
| 02230542 | IMODIUM QUICK DISSOLVE (loperamide hydrochloride 2 mg orodispersible tablet) MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | 02230542 | IMODIUM QUICK DISSOLVE (loperamide hydrochloride 2 mg oral tablet) MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC |
Questions, Concerns, Changes
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