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- International Nonproprietary Names (INN) identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. The INN system is managed by the World Health Organization (WHO).
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Dec 11, 2023 · International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2022. 11 December 2023. | Publication. Download (1.2 MB)
This document, first published on the website of the INN Programme in 2006, presents an inventory of the policy decisions taken by the INN Expert Group during these years of change, and of the names assigned to biological and biotechnological substances.
- International Nonproprietary Names (INN) Programme
- General policies for monoclonal antibodies [ 1, 3, 11, 23] 4
- Prefix
- General policies for immunoglobulins fractionated from plasma [ 9, 10]
- 2.10.General policies for skin substitutes [ 4]
- 2.12.General policies for vaccines [ 4- 7]
- CURRENT CHALLENGES
- The previous naming scheme for monoclonal antibodies
- Prefix:
- -toxa- infix
Technologies Standards and Norms (TSN) Regulation of Medicines and other Health Technologies (RHT) Essential Medicines and Health Products (EMP) International Nonproprietary Names (INN) for biological and biotechnological substances
INN for monoclonal antibodies (mAb) are composed of a prefix, a substem A, a substem B and a suffix. The common stem for mAbs is -mab, placed as a suffix. The stem -mab is to be used for all products containing an immunoglobulin variable domain which binds to a defined target. Substem B indicates the species on which the immunoglobulin sequence...
The prefix should be random, i.e. the only requirement is to contribute to a euphonious and distinctive name.
Not to select an INN for immunoglobulins fractionated from plasma is the current policy. The "systematic" or descriptive name is essential since the prescriber must know all the information conveyed by it and there is no benefit in assigning an INN from which it will not be readily apparent.
The products within this system are made of cells within a matrix, and skin substitutes can be considered to be engineered tissue and thus fall outside the scope of the INN system.
(under discussion) Vaccines are traditionally considered to be medicinal substances used to stimulate an individual’s immune system into providing protection against a particular infectious disease. Traditional vaccines consist of whole killed pathogens, live attenuated pathogens, subunits (antigens) derived from pathogens, or inactivated pathogeni...
The challenges currently faced by the INN Expert Group include: The use of a Biological Qualifier separate from the INN scheme to identify the source of a biological substance to enable substances to be traced in different licensing systems, whether classified as ‘similar biological substances’ or not. Formulation of policies for naming fusion prot...
The common stem for monoclonal antibodies is Sub-stems for source of product: -mab. The distinction between chimeric and humanized antibodies is as follows: chimeric antibody is one that contains contiguous foreign-derived amino acids comprising the entire variable region of both heavy and light chains linked to heavy and light constant regions...
Should be random e.g. the only requirement is to contribute to a euphonious and distinctive name.
For monoclonals conjugated to a toxin, the infix -toxa- can be inserted either into the first (main) name or included in the second word.
The School of INN (International Nonproprietary Names) In 1950 WHO established the INN Programme to provide a common language for people all over the world to work together for the safe and effective use of medicines. The main objective of the programme is to. define a single, unique, globally accepted name for each pharmaceutical substance.
nonproprietary names are selected for these inactive moieties, and published in proposed lists under the title "names for radicals and groups". If a "radical and group name" is used in conjunction with an INN, it is also referred to as an INNM. In some cases, a name of an INN Radical describes more than one substituent, e.g. (names in
INN Working Doc. 19.449 February 2019 Distr.: PUBLIC ENGLISH ONLY 67th Consultation on International Nonproprietary Names for Pharmaceutical Substances Geneva, 23-26 October 2018 Executive Summary Programme on International Nonproprietary Names (INN) Technologies Standards and Norms Regulation of Medicines and other Health Technologies (RHT)
International Nonproprietary Names (INN) for biological and biotechnological substances (a review) 2019 When autocomplete results are available use up and down arrows to review and enter to select. Select language English العربية 中文 Français Русский Español
