Ennov InSight Registrations 7.1

Pharmaceutical Product Attributes

The Pharmaceutical Product entity is required by the European Medicines Agency (EMA) for XEVMPD schema support.

The following attributes describe the specific Pharmaceutical Product under the Product.

Attribute Description
Family Type The type of products associated with this product family (for example: pharmaceutical, medical device).
Family Code The company-specific code for the product family.
Family Name The standard name recognized internally and across countries.
Product Name The standard product name recognized internally and across countries. On some pages, the product name is shown with the product code to identify a product. For example, Origine 390 could identify a product that has the name Origine and the code 390.
Pharmaceutical Product Name The standard pharmaceutical product name recognized internally and across countries. The product name must be unique.
Pharmaceutical Product Summary The value in the field is displayed as a concatenation of the values:
  • First line: Administrable Dose Form + Route of Administration divided by space.
  • Second Line: List of Active Ingredient Name values (or Reference Active Ingredient if specified) + Unit of Presentation + Strength, divided by comma.
    • Active Ingredients are in the alphabetical order
    • If a reference active ingredient is defined, no corresponding active ingredients are in the list.
    • If there are no pharmaceutical active ingredients, the component active ingredients show.
    • The strength values Equal to and Range do not show in the Pharmaceutical Product Summary field.
    • The Strength is defined by IDMP presentation values, if not specified, IDMP concentration values are taken. Otherwise, XEVMPD strength values are present. Otherwise, an active ingredient name with empty strength value.
  • If the Pharmaceutical Product Description and Unit of Presentation values are empty, no third line is available.
By default, the field is hidden.
Medical Device Describes the code of a medical device where it forms an integral part of the medicinal product.
Components The parts that build the final product. Selected list includes selected Components for the Pharmaceutical Product.
Administrable Dose Form The physical form in which this product is administered.
Product Quantity Value The quantity (or count number) of the pharmaceutical product. By default, the field is hidden.
Product Quantity Unit The quantity (or count number) of the pharmaceutical product. By default, the field is hidden.
Unit of Presentation The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate.
Product Characteristics The individual value from the code system that describes the actual characteristic. By default, the field is hidden.
Pharmaceutical Product Concerned Parties Contains email addresses and User Ids for which Notifications can be sent. Concerned parties are anyone who may be copied on notifications about this entity; use semi-colons (;) to separate e-mail addresses
Pharmaceutical Product Keywords Words you can use to search for the Pharmaceutical Product.
Pharmaceutical Product Description Text that describes the Pharmaceutical Product.
Pharmaceutical Product Comments The discussion thread that includes all comments entered by users; includes the date and time the comments were entered and the user ID of the person who entered them.
Pharmaceutical Product Add Comment Comments you want to share with others in a discussion thread. Will be displayed in the Pharmaceutical Product Comments box, stamped with the date and time you enter the information and your user ID.
Note: The Pharmaceutical Product Add Comment field is available on the Create/Modify Pharmaceutical Product Attributes pages only.
Route of Administration Defines how this product is introduced into the system, such as oral, and intravenous. Route of Administration is dependent on Dosage Form - this may be defined at either the product level or at the individual component level or both.