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  3. Medical (general)

l’indication de l’autorisation de mise sur le marché

English translation: (therapeutic) indication covered by the marketing authorisation

01:06 May 24, 2019
French to English translations [PRO]
Medical - Medical (general) / Pharmaceuticals
French term or phrase: l’indication de l’autorisation de mise sur le marché
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"
Yves Barry Ben
France
Local time: 15:23
English translation:(therapeutic) indication covered by the marketing authorisation
Explanation:
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
Selected response from:

Sue Davis
France
Local time: 15:23
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +7(therapeutic) indication covered by the marketing authorisation
Sue Davis
3 -1go-ahead with/for the market launch
David Hollywood


Discussion entries: 2





  

Answers


15 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): -1
go-ahead with/for the market launch


Explanation:
I would suggest

David Hollywood
Local time: 10:23
Native speaker of: English
PRO pts in category: 30

Peer comments on this answer (and responses from the answerer)
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
Login to enter a peer comment (or grade)

5 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +7
(therapeutic) indication covered by the marketing authorisation


Explanation:
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...

--------------------------------------------------
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

Sue Davis
France
Local time: 15:23
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 880

Peer comments on this answer (and responses from the answerer)
agree  Anne Schulz
1 hr
  -> Thanks Anne
agree  abe(L)solano
1 hr
  -> Thanks!
agree  Anton Konashenok
1 hr
  -> Thanks!
agree  liz askew
3 hrs
  -> Thanks Liz!
agree  Eliza Hall
1 day 2 hrs
  -> Thanks!
agree  Daryo
1 day 21 hrs
  -> Thanks!
agree  Dr. Elmehdi Hakkou (X)
4 days
Login to enter a peer comment (or grade)



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