tilladelsespræparat

English translation: unauthorised medicinal product

17:58 May 23, 2017
Danish to English translations [PRO]
Medical - Medical: Pharmaceuticals / corporate structure
Danish term or phrase: tilladelsespræparat
I know what this is - but not what it's called in English (if there is a term for it in English): http://www.ouh.dk/wm275055
Diarmuid Kennan
Ireland
Local time: 10:48
English translation:unauthorised medicinal product
Explanation:
"The compassionate use procedure is laid down in Article 83 of Regulation (EC) No 726/2004. It refers to the use of an unauthorised medicinal product under limited and strictly controlled conditions to allow certain patients earlier access to medicines. The concept goes back to Directive 2001/83/EC: Member States can make national arrangements for health professionals to commission the manufacture of an unauthorised medicine to fulfil the 'special needs' of a patient under their 'direct personal responsibility'."
Selected response from:

Charles Ek
United States
Local time: 05:48
Grading comment
Thanks Charles
4 KudoZ points were awarded for this answer



Summary of answers provided
4unauthorised medicinal product
Charles Ek
2 +1unlicensed medicine
Norskpro
1unapproved compounded medication / unapproved prescription drug
andres-larsen


  

Answers


17 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): +1
unlicensed medicine


Explanation:
Maybe this is it.


    https://www.britishpainsociety.org/static/uploads/resources/files/useofmeds_professional_final.pdf
Norskpro
Norway
Local time: 11:48
Native speaker of: Native in NorwegianNorwegian
Notes to answerer
Asker: Thanks for this, but Charles answer was slightly better in my specific context.


Peer comments on this answer (and responses from the answerer)
agree  Christopher Schröder
19 hrs
  -> Thank you.
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30 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
unauthorised medicinal product


Explanation:
"The compassionate use procedure is laid down in Article 83 of Regulation (EC) No 726/2004. It refers to the use of an unauthorised medicinal product under limited and strictly controlled conditions to allow certain patients earlier access to medicines. The concept goes back to Directive 2001/83/EC: Member States can make national arrangements for health professionals to commission the manufacture of an unauthorised medicine to fulfil the 'special needs' of a patient under their 'direct personal responsibility'."


    Reference: http://www.europarl.europa.eu/RegData/etudes/IDAN/2015/55417...
Charles Ek
United States
Local time: 05:48
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 16
Grading comment
Thanks Charles
Login to enter a peer comment (or grade)

1 day 50 mins   confidence: Answerer confidence 1/5Answerer confidence 1/5
unapproved compounded medication / unapproved prescription drug


Explanation:
Unapproved Drugs List
https://www.ijpc.com/Patient_Info/Unapproved_Drugs.pdf
All compounded medications, including pediatric preparations, HRT preparations, cancer combinations, intravenous admixtures, pain management medications, high-dose pain medications, medications in short supply, discontinued medications, dye-free, preservative-free, fragrance-free medications, infant medications, small children medications, new therapeutic approaches to difficult to treat diseases, drugs compounded for clinical studies ... Yes, there are many vitally important unapproved drugs that are commercially available today.

Unapproved Prescription Drugs: Drugs Marketed in the United States ...
https://www.fda.gov/drugs/.../selectedenforcementactionsonun...
3 ene. 2017 - Because unapproved and illegally marketed prescription and over-the-counter drugs pose a significant public health concern, the FDA has ...

Unapproved Prescription Drugs: FDA Actions
https://www.fda.gov/Drugs/.../SelectedEnforcementActionsonUn...
Since publication of the Compliance Policy Guide (CPG) for Marketed Unapproved Drugs (drugs marketed without approved NDAs and ANDAs) (CPG Sec.

How Unapproved Drugs Make it to Market | TIME.com
healthland.time.com/.../how-do-unapproved-drugs-make-it-to-ma...
3 mar. 2011 - It may come as a surprise that some of the drugs your doctor can prescribe have not been approved by the Food and Drug Administration (FDA) ...

Prescription Drugs UNAPPROVED by the FDA - Vaughn's Summaries
www.vaughns-1-pagers.com/.../prescription-drugs-unapproved....
4 mar. 2015 - Doctors write 65 million prescriptions each year for unapproved drugs. The FDA has REFUSED to provide a list of unapproved drugs, in spite of ...

andres-larsen
Venezuela
Local time: 06:48
Native speaker of: Native in EnglishEnglish
PRO pts in category: 4
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