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mozno ten clanok naraza aj na tieto praktiky: Once a drug is approved for at least one indication, it may be prescribed off-label for a different condition, a different population, or in a different dose than what the drug is approved for. However, off-label uses have not been subject to the testing and review that is a precondition for marketing approval. The scientific review of evidence of effectiveness and safety that regulators weigh prior to approval for a labeled indication protects the patient. With off-label use, this protection often does not exist. http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050210 |
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