Naming Tips for Pharmaceutical Modifiers in Key European Markets

Naming Tips for Pharmaceutical Modifiers in Key European Markets

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All regions consider qualifiers or modifiers to be technical words or word parts that should communicate a unique characteristic about the medicinal product and are considered part of the medicinal product name.  In addition, the use of a modifier (versus a new unique product name) should be weighed on a case-by-case basis against the risks associated regarding prescribing errors or confusion in practice by patients and/or healthcare professionals.

Consider the following comparative analysis for the modifier or descriptor “DUO.”

Modifier/Descriptor Region Acceptable? Meaning / Conditions
Duo Austria Yes contain two active ingredients
Duo France No DUO is not sufficiently informative and may cause confusion regarding qualitative or quantitative composition, or drug properties.
Duo Germany Yes if the medicinal product contains two active ingredients.
Duo Spain Yes Used with Complex, Compuesto, and Plus when a new medicine adds an additional active ingredient to an authorized medicine.
Duo Switzerland Yes Used for combination products with complementary active substances.

We wanted to point out a few unique regional considerations for qualifiers or modifiers that should be considered prior to submitting the invented name for review.

AUSTRIA

  • Qualifiers can be written in Latin, Greek, or German, or represent commonly used terms in other languages; they should be understandable to the user and not require translation.
  • In addition to assisting in product selection, an additional benefit of a qualifier can be distinguishing a combination product from the corresponding mono-product, indicating modified release, indicating flavorings, etc.

SPAIN

  • As a general rule, qualifiers used for medicinal product in Spain should be used in Spanish. However, proposals where an English qualifier may be more appropriate will be evaluated on a case-by-case basis.
  • If the applicant proposes the use of a qualifier in the name, they must submit a document justifying its use based on the above criteria.

SWITZERLAND

  • Swissmedic can reassess a name extension if the reference medicinal product with the same medicinal product name within the core brand is no longer authorised.

 

Here are few examples of qualifiers that are acceptable under specific conditions (not exhaustive):

Region Qualifier Condition
Austria Forte Higher dosage than other medicinal products in the range
Austria Kleinkind For ages 28 days to 23 months
Austria Sine Ophthalmic products without preservatives
Austria MR Modified release
Austria Live vaccine Used for live vaccines
Region Qualifier Condition
France L.P. Extended release forms
France Sugar-free by adding the sweetener after the pharmaceutical form: "sweetened with..."
France Adults / Children / Infants / Neonates Population-specific indications
Region Qualifier Condition
Germany Akut for fast-acting medicines: to differentiate from normal-release medicines; exclusively for narcotic drugs: to differentiate between normal-release medicines and delayed-release medicines
Germany Cutan / Kutan for application to the skin
Germany Junior For a medicinal product that is approved exclusively for use in children or the dosage form was explicitly developed for children

Here are a few FAQ’s we have been asked about modifiers or descriptors…

As a general rule, qualifiers used for medicinal product in Spain should be used in Spanish.   

Examples include the following:

  • LACTANTES (INFANTS): For the population from 0 to 23 months
  • NIÑOS/KIDS (CHILDREN/KIDS): For the population from 2 to 11 years
  • ADOLESCENTS/TEENS: For the population from 12 to 17 years
  • ADULTOS (ADULTS): For the population from 18 years of age and older
  • PEDIÁTRICO (PEDIATRIC): Indication for an age range that includes infants, children, and adolescents.
  • FLAS: orodispersible forms
  • DIARIO (DAILY): For daily administration

However, proposals where an English qualifier may be more appropriate will be evaluated on a case-by-case basis.

Is data required to support the use of a modifier or qualifier?

  • Although it is suggested with any proposed name candidate, specifically for Spain and the United Kingdom, if the applicant proposes the use of a qualifier in the name, they must submit a document justifying its use.

Can the use of a modifier be limited or restricted? 

  • Yes.  Sometimes the use of a modifier or descriptor may be limited or restricted.  For example, the use of MR for a prolonged release preparation is no longer recommended by the MHRA (United Kingdom) because “Modified Release” can indicate a gastro-resistant product or a prolonged release product, therefore the term is not specific for an individual product.

Applicants are advised that the following suffixes should be used for prolonged release preparations, as appropriate to the particular product:

  • CR – Controlled release
  • LA – Long acting
  • PR – Prolonged release
  • SA – Sustained action
  • SR – Sustained release
  • XL – Prolonged release, once daily dosing. If a product can be given once or twice daily, a different suffix should be used.

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