off label product

French translation: produit utilisé hors AMM

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:off label product
French translation:produit utilisé hors AMM
Entered by: Bertrand Leduc

12:55 Feb 8, 2018
English to French translations [PRO]
Medical (general)
English term or phrase: off label product
- This program is an unaccredited learning


activity that has been developed


through support from Novo Nordisk Canada.


Novo Nordisk does not support product

01:01.80
discussion that is off-label,
Thierry Darlis
United States
Local time: 07:59
produit utilisé hors AMM
Explanation:
IMHO

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Note added at 21 minutes (2018-02-08 13:16:34 GMT)
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Clonazépam (RIVOTRIL®) per os utilisé hors AMM (notamment dans la douleur, les troubles anxieux et du sommeil) - Mise au point... Spécificité d'utilisation des médicaments courants hors antalgiques - Recommandations de bonne pratique (19/06/2008) application/pdf ...Spécificité d'utilisation des médicaments courants ...
http://ansm.sante.fr/searchengine/general_search?SearchText=...

--------------------------------------------------
Note added at 22 minutes (2018-02-08 13:17:19 GMT)
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Les produits les plus souvent prescrits hors AMM Les produits les plus souvent utilisés hors AMM par les généralistes
https://www.vidal.fr/actualites/15099/pediatrie_les_prescrip...
Selected response from:

Bertrand Leduc
United Kingdom
Local time: 12:59
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4produit dont l'utilisation diffère de celle recommandée sur l'étiquette
Sofia_Qc
4produit utilisé hors AMM
Bertrand Leduc
4 -1off-label / sans licence
Nadia A.
4 -2produit/médicament sans AMM
Drmanu49
Summary of reference entries provided
"off-label"
Daryo

Discussion entries: 1





  

Answers


5 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): -1
off-label / sans licence


Explanation:
http://www.eaasm.eu/utilisation-hors-amm-de-medicaments
Ce document explore l'utilisation de "off label" (sans licence) des médicaments

https://www.ordomedic.be/fr/avis/conseil/l-usage-off-label-d...
L'usage off label d'un médicament pose également la question de l'efficacité de cet usage

Nadia A.
Morocco
Local time: 12:59
Specializes in field
Native speaker of: Native in FrenchFrench
PRO pts in category: 16

Peer comments on this answer (and responses from the answerer)
disagree  Daryo: there is a "label" = authorised use [the intended one], otherwise the drug wouldn't be on sale at all!
15 hrs
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14 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): -2
produit/médicament sans AMM


Explanation:
Les médicaments sans A.M.M - le point vert de la pharmacie et la ...
pointvert.ecoleforum.com › le point vert de l 'industrie pharmaceutique

2 messages - ‎2 auteurs
Les médicaments sans AMM Il y a quatre catégories de médicaments dans cette situation : 1) Les médicaments bénéficiant d'une autorisation temporaire d'utilisat. ... Par définition, ces produits pharmaceutiques ne peuvent bénéficier d'une AMM. Leur fabrication est pourtant indispensable aux études et essais nécessaires ...

Drmanu49
France
Local time: 13:59
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 5010

Peer comments on this answer (and responses from the answerer)
disagree  Daryo: there is a "label" = authorised use [the intended one], otherwise the drug wouldn't be on sale at all // also, the "off" before "label" implies that there is a label in the first place ...
15 hrs
  -> Sans does NOT mean there was one to start out with, it may have been withdrawn. Check my ref.

disagree  Bertrand Leduc: avec Daryo
20 hrs
  -> Daryo a tort, Bertrand, on peut retirer son AMM à un produit.
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17 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
produit utilisé hors AMM


Explanation:
IMHO

--------------------------------------------------
Note added at 21 minutes (2018-02-08 13:16:34 GMT)
--------------------------------------------------

Clonazépam (RIVOTRIL®) per os utilisé hors AMM (notamment dans la douleur, les troubles anxieux et du sommeil) - Mise au point... Spécificité d'utilisation des médicaments courants hors antalgiques - Recommandations de bonne pratique (19/06/2008) application/pdf ...Spécificité d'utilisation des médicaments courants ...
http://ansm.sante.fr/searchengine/general_search?SearchText=...

--------------------------------------------------
Note added at 22 minutes (2018-02-08 13:17:19 GMT)
--------------------------------------------------

Les produits les plus souvent prescrits hors AMM Les produits les plus souvent utilisés hors AMM par les généralistes
https://www.vidal.fr/actualites/15099/pediatrie_les_prescrip...

Bertrand Leduc
United Kingdom
Local time: 12:59
Specializes in field
Native speaker of: Native in FrenchFrench
PRO pts in category: 1213

Peer comments on this answer (and responses from the answerer)
agree  Daryo
15 hrs

disagree  Drmanu49: Non, pour moi c'est qui n'a plus d'AMM.
20 hrs
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45 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
produit dont l'utilisation diffère de celle recommandée sur l'étiquette


Explanation:
If your customer is Canadian, I suggest your sources be validated in that market


    https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents/advert
    https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/exigences-reglementaires-publicite/politiques-lignes-directrices/o
Sofia_Qc
Canada
Local time: 07:59
Native speaker of: Native in FrenchFrench

Peer comments on this answer (and responses from the answerer)
agree  Daryo
15 hrs

disagree  Drmanu49: Not valid in France.
19 hrs
  -> the company is Novo Nordisk Canada, the product is most likely from Canada
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Reference comments


1 day 1 hr
Reference: "off-label"

Reference information:
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration.[1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.

https://en.wikipedia.org/wiki/Off-label_use


Understanding Unapproved Use of Approved Drugs "Off Label"

Has your healthcare provider ever talked to you about using an FDA-approved drug for an unapproved use (sometimes called an “off-label”
use) to treat your disease or medical condition?
...
https://www.fda.gov/ForPatients/Other/OffLabel/ucm20041767.h...

Off-Label Drug Use: What You Need to Know
Prescription drugs are often prescribed for uses other than what the FDA has approved. Find out why.
https://www.webmd.com/a-to-z-guides/features/off-label-drug-...

Ten Common Questions (and Their Answers) About Off-label Drug Use
Abstract
The term off-label drug use (OLDU) is used extensively in the medical literature, continuing medical education exercises, and the media. Yet, we propose that many health care professionals have an underappreciation of its definition, prevalence, and implications. This article introduces and answers 10 questions regarding OLDU in an effort to clarify the practice's meaning, breadth of application, acceptance, and liabilities. Off-label drug use involves prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US Food and Drug Administration. Since the Food and Drug Administration does not regulate the practice of medicine, OLDU has become common. It occurs in every specialty of medicine, but it may be more common in areas of medicine in which the patient population is less likely to be included in clinical trials (eg, pediatric, pregnant, or psychiatric patients). Pharmaceutical companies are not allowed to promote their medications for an off-label use, which has lead to several large settlements for illegal marketing. To limit liability, physicians should prescribe medications only for indications that they believe are in the best interest of the patient. In addition, health care professionals should educate themselves about OLDU to weigh th...e risks and benefits and provide the best possible care for their patients.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/


etc etc etc

Daryo
United Kingdom
Works in field
Native speaker of: Native in SerbianSerbian, Native in FrenchFrench
PRO pts in category: 63
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