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  3. Medical: Pharmaceuticals

off-label

Croatian translation: nenamjenska uporaba/uporaba van odobrenih indikacija

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:off-label
Croatian translation:nenamjenska uporaba/uporaba van odobrenih indikacija
Entered by: Andreja Ciković

22:34 Jul 18, 2012
English to Croatian translations [PRO]
Medical - Medical: Pharmaceuticals / medications
English term or phrase: off-label
http://en.wikipedia.org/wiki/Off-label_use

Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration.[1] In the United States, the Food and Drug Administration Center for Drug Evaluation and Research (CDER) reviews a company's New Drug Application (NDA) for data from clinical trials to see if the results support the drug for a specific use or indication.[2] If satisfied that the drug is safe and effective, the drug's manufacturer and the FDA agree on specific language describing dosage, route of administration, and other information to be included on the drug's label. More detail is included in the drug's package insert.
Andreja Ciković
Croatia
nenamjenska uporaba/uporaba van odobrenih indikacija
Explanation:
prijedlog
Selected response from:

Dinap
Croatia
Local time: 16:05
Grading comment
Hvala!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1nenamjenska uporaba/uporaba van odobrenih indikacija
Dinap


  

Answers


9 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
nenamjenska uporaba/uporaba van odobrenih indikacija


Explanation:
prijedlog

Dinap
Croatia
Local time: 16:05
Specializes in field
Native speaker of: Native in CroatianCroatian
PRO pts in category: 124
Grading comment
Hvala!

Peer comments on this answer (and responses from the answerer)
agree  Sonja Trzin
39 days
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