TERMIUM Plus®
The Government of Canada’s terminology and linguistic data bank.
DRUG ENTITY [5 records]
Record 1 - internal organization data 2021-01-13
Record 1, English
Record 1, Subject field(s)
- Pharmaceutical Manufacturing
- Medication
- Medical Instruments and Devices
Record 1, Main entry term, English
- market authorization holder
1, record 1, English, market%20authorization%20holder
correct
Record 1, Abbreviations, English
- MAH 1, record 1, English, MAH
correct
Record 1, Synonyms, English
Record 1, Textual support, English
Record number: 1, Textual support number: 1 DEF
... the legal entity that holds the Notice of Compliance, the Drug Identification Number(DIN), the medical device licence number, the product licence number, or that has received approval to initiate clinical trials in Canada. 2, record 1, English, - market%20authorization%20holder
Record 1, French
Record 1, Domaine(s)
- Fabrication des produits pharmaceutiques
- Médicaments
- Instruments et appareillages médicaux
Record 1, Main entry term, French
- détenteur d'une autorisation de mise sur le marché
1, record 1, French, d%C3%A9tenteur%20d%27une%20autorisation%20de%20mise%20sur%20le%20march%C3%A9
correct, masculine noun
Record 1, Abbreviations, French
- DAMM 1, record 1, French, DAMM
correct, masculine noun
Record 1, Synonyms, French
- titulaire d'une autorisation de mise sur le marché 2, record 1, French, titulaire%20d%27une%20autorisation%20de%20mise%20sur%20le%20march%C3%A9
correct, masculine noun
- TAMM 3, record 1, French, TAMM
correct, masculine noun
- TAMM 3, record 1, French, TAMM
- détenteur d'une AMM 4, record 1, French, d%C3%A9tenteur%20d%27une%20AMM
correct, masculine noun
- titulaire d'une AMM 5, record 1, French, titulaire%20d%27une%20AMM
correct, masculine noun
Record 1, Textual support, French
Record 1, Spanish
Record 1, Textual support, Spanish
Record 2 - internal organization data 2018-02-26
Record 2, English
Record 2, Subject field(s)
- Official Documents
- Medication
- General Medicine, Hygiene and Health
Record 2, Main entry term, English
- new drug submission
1, record 2, English, new%20drug%20submission
correct, see observation, Canada, standardized
Record 2, Abbreviations, English
- NDS 2, record 2, English, NDS
correct, see observation, Canada
Record 2, Synonyms, English
- new drug application 3, record 2, English, new%20drug%20application
correct, see observation, United States, standardized
- NDA 4, record 2, English, NDA
correct, see observation, United States, standardized
- NDA 4, record 2, English, NDA
Record 2, Textual support, English
Record number: 2, Textual support number: 1 DEF
An application submitted by a manufacturer to [the competent authorities] for approval to market a new drug(a new, non-biological molecular entity) for human use. 3, record 2, English, - new%20drug%20submission
Record number: 2, Textual support number: 1 OBS
new drug submission; new drug application; NDA: terms, abbreviation and definition standardized by the Health Technology Assessment (HTA) Glossary English Editorial Board and the Translation Bureau. 5, record 2, English, - new%20drug%20submission
Record 2, French
Record 2, Domaine(s)
- Documents officiels
- Médicaments
- Médecine générale, hygiène et santé
Record 2, Main entry term, French
- présentation de nouveau médicament
1, record 2, French, pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament
correct, feminine noun, standardized
Record 2, Abbreviations, French
- PNM 2, record 2, French, PNM
correct, feminine noun, standardized
Record 2, Synonyms, French
- dossier d'autorisation de mise sur le marché 1, record 2, French, dossier%20d%27autorisation%20de%20mise%20sur%20le%20march%C3%A9
correct, masculine noun, France, standardized
- dossier d'AMM 1, record 2, French, dossier%20d%27AMM
correct, masculine noun, France, standardized
- dossier de demande d'autorisation de mise sur le marché 1, record 2, French, dossier%20de%20demande%20d%27autorisation%20de%20mise%20sur%20le%20march%C3%A9
correct, masculine noun, France, standardized
- dossier de demande d'AMM 1, record 2, French, dossier%20de%20demande%20d%27AMM
correct, masculine noun, France, standardized
- présentation de drogue nouvelle 1, record 2, French, pr%C3%A9sentation%20de%20drogue%20nouvelle
see observation, feminine noun, Canada
- PDN 2, record 2, French, PDN
see observation, feminine noun, Canada
- PDN 2, record 2, French, PDN
Record 2, Textual support, French
Record number: 2, Textual support number: 1 DEF
Demande soumise par un fabricant [aux autorités compétentes] pour l'autorisation de commercialiser un nouveau médicament (une nouvelle entité moléculaire non biologique) pour usage chez l'humain. 1, record 2, French, - pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament
Record number: 2, Textual support number: 1 OBS
Le terme «présentation de drogue nouvelle» (PDN) est à éviter, car «drogue» n'a pas le sens de «médicament» que le terme anglais «drug» peut avoir. En français, une drogue est soit une substance dont on fait un usage abusif à des fins non médicamenteuses, soit la matière première de certains médicaments. Toutefois, Santé Canada emploie «présentation de drogue nouvelle», et les fabricants peuvent être obligés de l'utiliser afin de se conformer aux exigences du Règlement sur les aliments et drogues. 1, record 2, French, - pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament
Record number: 2, Textual support number: 2 OBS
présentation de nouveau médicament; PNM; dossier d'autorisation de mise sur le marché; dossier d'AMM; dossier de demande d'autorisation de mise sur le marché; dossier de demande d'AMM : termes et abréviation normalisés par l'Institut national d'excellence en santé et en services sociaux (INESSS) et le Bureau de la traduction. 3, record 2, French, - pr%C3%A9sentation%20de%20nouveau%20m%C3%A9dicament
Record 2, Spanish
Record 2, Textual support, Spanish
Record 3 - internal organization data 2010-07-06
Record 3, English
Record 3, Subject field(s)
- Morphology and General Physiology
Record 3, Main entry term, English
- chronomodulation 1, record 3, English, chronomodulation
Record 3, Abbreviations, English
Record 3, Synonyms, English
Record 3, Textual support, English
Record number: 3, Textual support number: 1 CONT
Patterns of interaction, in this context, involve attenuation, no-effect and/or amplification by a third entity, the modulator, of the effect of an actor upon the reactor. Such feedsidewards lead to chronomodulation, a phenomenon accounting for qualitatively as well as quantitatively different modulatory effects of the same drug or other stimulus. 1, record 3, English, - chronomodulation
Record 3, French
Record 3, Domaine(s)
- Morphologie et physiologie générale
Record 3, Main entry term, French
- chronomodulation
1, record 3, French, chronomodulation
correct, feminine noun
Record 3, Abbreviations, French
Record 3, Synonyms, French
Record 3, Textual support, French
Record 3, Spanish
Record 3, Textual support, Spanish
Record 4 - internal organization data 1991-03-26
Record 4, English
Record 4, Subject field(s)
- Pharmacology
Record 4, Main entry term, English
- drug entity 1, record 4, English, drug%20entity
Record 4, Abbreviations, English
Record 4, Synonyms, English
Record 4, French
Record 4, Domaine(s)
- Pharmacologie
Record 4, Main entry term, French
- agent pharmacologique
1, record 4, French, agent%20pharmacologique
masculine noun
Record 4, Abbreviations, French
Record 4, Synonyms, French
Record 4, Textual support, French
Record 4, Spanish
Record 4, Textual support, Spanish
Record 5 - internal organization data 1976-06-19
Record 5, English
Record 5, Subject field(s)
- Pharmacology
Record 5, Main entry term, English
- single entity drug 1, record 5, English, single%20entity%20drug
Record 5, Abbreviations, English
Record 5, Synonyms, English
Record 5, French
Record 5, Domaine(s)
- Pharmacologie
Record 5, Main entry term, French
- produit ne contenant qu'un seul ingrédient actif 1, record 5, French, produit%20ne%20contenant%20qu%27un%20seul%20ingr%C3%A9dient%20actif
Record 5, Abbreviations, French
Record 5, Synonyms, French
Record 5, Textual support, French
Record 5, Spanish
Record 5, Textual support, Spanish
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