May 24, 2019 01:06
5 yrs ago
2 viewers *
French term
France
Native in: English
l’indication de l’autorisation de mise sur le marché
French to English
Medical
Medical (general)
Pharmaceuticals
Context :
A drug which benefits from a marketing authorization.
"le service médical rendu par le médicament restait important dans l’indication de l’autorisation de mise sur le marché"
A drug which benefits from a marketing authorization.
"le service médical rendu par le médicament restait important dans l’indication de l’autorisation de mise sur le marché"
Proposed translations
(English)
| 4 +7 | (therapeutic) indication covered by the marketing authorisation |
Sue Davis
|
| 3 -1 | go-ahead with/for the market launch |
David Hollywood
|
Proposed translations
+7
5 hrs
Selected
(therapeutic) indication covered by the marketing authorisation
Drugs are authorised to be used for a specific pathologies/treatment situations. If a company wishes to market it for use in a new indication, they have to reapply for this to be authorised.
https://www.ema.europa.eu/en/documents/presentation/presenta...
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Note added at 5 hrs (2019-05-24 06:39:15 GMT)
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https://www.drugs.com/new-indications.html
New Indications & Dosage Forms for Existing Drugs
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
Fragmin (dalteparin sodium) Injection
Patient Population Altered: May 16, 2019
Date of Original Approval: December 22, 1994
Fragmin (dalteparin sodium) is a low molecular weight heparin (LMWH) indicated for:
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
https://www.ema.europa.eu/en/documents/presentation/presenta...
--------------------------------------------------
Note added at 5 hrs (2019-05-24 06:39:15 GMT)
--------------------------------------------------
https://www.drugs.com/new-indications.html
New Indications & Dosage Forms for Existing Drugs
Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.
Fragmin (dalteparin sodium) Injection
Patient Population Altered: May 16, 2019
Date of Original Approval: December 22, 1994
Fragmin (dalteparin sodium) is a low molecular weight heparin (LMWH) indicated for:
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
Peer comment(s):
| agree |
Anne Schulz
1 hr
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|
Thanks Anne
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| agree |
abe(L)solano
1 hr
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Thanks!
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| agree |
Anton Konashenok
1 hr
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Thanks!
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| agree |
liz askew
3 hrs
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Thanks Liz!
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| agree |
Eliza Hall
1 day 2 hrs
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Thanks!
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| agree |
Daryo
1 day 21 hrs
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Thanks!
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| agree |
Dr. Elmehdi Hakkou (X)
4 days
|
4 KudoZ points awarded for this answer.
-1
15 mins
David Hollywood
Native in English
worked for int. orgs (IMF, OAS, IDB)
Native in: English
Works in: Spanish to English, German to English
Related KudoZ points
:
30
go-ahead with/for the market launch
I would suggest
Peer comment(s):
| neutral |
writeaway
: a bit too colloquial/laid-back/turns out it's dead wrong
2 hrs
|
| disagree |
Daryo
: whatever the wording might superficially suggest, it's in fact an "authorisation to be used in human medicine" - and only under the specified conditions of indications/dosage etc ...
2 days 3 hrs
|
Discussion