Product Name Does Not Populate in PMDA E2B (R3) Paper Report if the Length of Generic Name for Concomitant Drug Exceeds 250AN (Doc ID 2614968.1)

Last updated on JULY 13, 2023

Applies to:

Symptoms

In the Case Form > Products tab, a concomitant drug has been set and the generic name of this drug contains more than 250 AN.

When printing the PMDA E2B (R3) paper report from this case, the primary suspect name does not display and only J-Drug Code populates in the report.

Steps to replicate the issue:

1. Create a new case with Japan license
2. In the Products tab add a new concomitant drug

For example, enter product name "OVACARE" and tab out so that WHO-Drug window appears, then press [Select].

       Product Name : OVACARE
       Generic Name : AMINOBENZOIC ACID, ARGININE, ASCORBIC ACID, CHROMIUM,
                              COLECALCIFEROL, COPPER, CYANOCOBALAMIN, FOLIC ACID, INOSITOL, IODINE, IRON,
                              MAGNESIUM, MANGANESE, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL,
                              RIBOFLAVIN, SELENIUM, THIAMINE, VITAMIN E NOS, ZINC

                              (The length of the generic name exceed 250 characters.)

3. Save the case
4. Enter the mandatory information for PMDA E2B (R3)
5. Save the case
6. Schedule PMDA E2B (R3) or PMDA E2B (R3) PAPER report
7. View the report
8. Change the view format to PMDA Paper report
9. Review the output value of the product

In the product information section/column, only J-Drug Code displays.

Changes

Cause

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