French: ampliationEnglish translation: supplemental new drug application (sNDA) 
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| GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | | French term or phrase: | ampliation | | English translation: | supplemental new drug application (sNDA) | | Entered by: | Enza Longo |
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French to English translations [PRO]
Medical - Medical: Pharmaceuticals / drug approval | | French term or phrase: ampliation | NOT amplification (I've checked)
It is a new dosage and application of an existing drug that is being approved by a Ministry.
This is also referred to as 'Ajout'. |
| | Clarification request(s) and responseEnza Longo: 11:01pm Dec 23, 2006: it could be 'expansion'. In what sense/context is the word used?
ericjanpost: 11:44pm Dec 23, 2006: Ampliation - There is a drug on the market which a commercial laboratory wishes to sell in different packaging, by injection instead of through oral intake.
They require some type of authorization: 'Lettre de demande pour ajouter d'une nouvelle présentation + lettre d'accord
blavatsky: 4:30am Dec 24, 2006: Do you have the sentence concerned ?
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| | supplemental new drug application (sNDA) | Explanation:
Drugs@FDA: Glossary of TermsIn Drugs@FDA, you can find the NDA number under the column named "FDA Application." ... a company must submit a supplemental new drug application (sNDA). ...
www.fda.gov/cder/drugsatfda/glossary.htm - 35k - Cached - Similar pages
[PDF] Harmonized Core Report Style Template (Version 3.0)File Format: PDF/Adobe Acrobat - View as HTML
Using a more conservative definition of clinical benefit, requiring ... therapy might support regular approval. A supplemental NDA (sNDA) was ...
www.fda.gov/ohrms/dockets/AC/05/briefing/2005-4191B1_02_Joh... - Similar pages
Sample Contracts - Interim Supply Agreement [Amendment No. 1 ...The following definitions in Section 1.1 of the Supply Agreement are hereby ... 3 <PAGE> At such time as each Reformulation NDA and the SNDA is approved, ...
contracts.onecle.com/aaipharma/astrazeneca.supp1.2003.07.22.shtml - 26k - Cached - Similar pages
[DOC] GLOSSARYFile Format: Microsoft Word - View as HTML
Supplemental NDA (sNDA):. Documentation submitted to FDA on a drug ... For example, under this definition, hepatic necrosis would be unexpected (by virtue ...
www.temple.edu/pharmacy_qara/GLOSSARY.doc - Similar pages
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Note added at 13 hrs (2006-12-24 12:07:13 GMT)
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ampliation could then be translated as 'supplement' |
| Selected response from:
 Enza Longo
Canada
| Note from asker to answererTerrific work. Merci.
4 KudoZ points were awarded for this answer |
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1 hr confidence:   peer agreement (net): +1 |
| Ampliation exemplified copy, exemplification
Explanation:
This is only a guess but I think it fits the context. An exemplified copy is a copy of a legal pleading in its entirety (per wikipedia) and if you're talking about requesting a new dosage for a drug this would be required for the marketing authorization. I'd have to see the full text to be sure though.
Reference: http://ec.europa.eu/eurodicautom/Controller
| Janet Ratziu
France
Specializes in field
Native speaker of:  English
PRO pts in category: 40
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| Notes to answerer
Asker: Thanks very much Janet. The issue is not the type of copy however, but the idea of adding a supplement to a patent, without actually creating anything new (packaging, how a medication is administered: in this case, going from oral intake to injection).
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12 hrs confidence: |
| Ampliation ampliation
Explanation:
found many refs in English but so scattered cannot give them! No doubt the same word applies
my refs if you wish to have a go, via google with either ampliation+pharmacy or ampliation+medicines
| | Notes to answerer
Asker: Thanks Catherine. Correct answer seems to be sNDA, or supplemental new drug application. Thanks
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12 hrs confidence: |
| Ampliation supplemental new drug application (sNDA)
Explanation:
Drugs@FDA: Glossary of TermsIn Drugs@FDA, you can find the NDA number under the column named "FDA Application." ... a company must submit a supplemental new drug application (sNDA). ...
www.fda.gov/cder/drugsatfda/glossary.htm - 35k - Cached - Similar pages
[PDF] Harmonized Core Report Style Template (Version 3.0)File Format: PDF/Adobe Acrobat - View as HTML
Using a more conservative definition of clinical benefit, requiring ... therapy might support regular approval. A supplemental NDA (sNDA) was ...
www.fda.gov/ohrms/dockets/AC/05/briefing/2005-4191B1_02_Joh... - Similar pages
Sample Contracts - Interim Supply Agreement [Amendment No. 1 ...The following definitions in Section 1.1 of the Supply Agreement are hereby ... 3 <PAGE> At such time as each Reformulation NDA and the SNDA is approved, ...
contracts.onecle.com/aaipharma/astrazeneca.supp1.2003.07.22.shtml - 26k - Cached - Similar pages
[DOC] GLOSSARYFile Format: Microsoft Word - View as HTML
Supplemental NDA (sNDA):. Documentation submitted to FDA on a drug ... For example, under this definition, hepatic necrosis would be unexpected (by virtue ...
www.temple.edu/pharmacy_qara/GLOSSARY.doc - Similar pages
--------------------------------------------------
Note added at 13 hrs (2006-12-24 12:07:13 GMT)
--------------------------------------------------
ampliation could then be translated as 'supplement'
| Enza Longo
Canada
Native speaker of: English
PRO pts in category: 8
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7 days confidence: |
| certified copy
Explanation:
This term comes at the bottom of all French Marketing Authorisations sent back by Afssaps to the drug companies certifying that the paper copy is identical to the orginal MA.
| NR_Stedman
France
Specializes in field
Native speaker of: English
PRO pts in category: 26
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The translation workplace 
