Substances is the common term for active ingredients and excipients
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Norwegian terms for substances must be assessed and approved by the Norwegain Medical Product Agency.
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Substances - an overarching term for active ingredients and excipients
The provided text explains that NoMA (likely referring to a pharmaceutical or regulatory management system) adheres to standards set in international databases, primarily following INN, International Nonproprietary Names, which are globally recognized for active pharmaceutical substances.
Additionally, NoMA aligns with monograph titles in the Ph. Eur. (European Pharmacopoeia) when these are unambiguous regarding structural formulas.
The EMA (European Medicines Agency) has established Substance Management Services, SMS, to manage all substances used in European medicinal products. NoMA has been involved in this process from its inception, ensuring that all substances included in preparations are quality-assured and listed in NoMA's database with a single, valid name — referencing the importance of standardized naming for safety and clarity.
Translations and SMS
During the spring of 2025, translations for all substances in our own database have been quality assured against what is available in SMS. All incorrect translations have been marked as "Non_current" and can no longer be used. The correct Norwegian translations have been updated in SMS; see the complete Excel list at SMS/EMA.
NoMA aims to be the organization responsible for forwarding correct translations. We kindly ask the industry and others to contact Kodeverk@dmp.no as soon as possible if updates are needed. DMP is happy to create valid substances in our system with the correct English and Norwegian terms before they are included in approved preparations and related documents, such as SmPC and package leaflets.
Special solutions for the FHIR service for substances
NoMA lists all electrolytes as ions, as they are otherwise considered chemical elements, in accordance with IDMP. To make this more suitable for users, an alias solution has been implemented in the FHIR service.
Therefore, an alias is published in a separate field, as it is practical to read the terms without the suffix “-ion.” See examples below. For minerals that can have different charges, such as iron, this is retained in parentheses.
- Jern(II)ion is shown as Jern(II) = Ferrous
- Jern(III)ion is shown as Jern(III) = Ferric
- Kalsiumion is shown as Kalsium = Calcium
- Natriumion is shown as Natrium = Sodium
As duplicates should not exist, it is possible to add synonyms that are not correct names but are in use, with both Norwegian and English terms, to the FHIR service. In SMS, these can be identified with an SVG flag = 0, indicating that this is not the preferred term (Preferred term).