Prescribing information: difference between revisions
Diff·revision 8 → 9·03:46, 2 Jan 2025
Difference between revision 8 and revision 9 of Prescribing information. 14 lines changed; the page grew by 850 bytes.
| Revision 8 — 03:59, 19 Dec 2024 CategoryBot (talk) bot: normalise currency formatting 2,473 bytes ±0 | Revision 9 — 03:46, 2 Jan 2025 IpamorelinIsold (talk) add category for pricing 3,323 bytes +850 | ||
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| 1 | {{Infobox concept | 1 | {{Infobox concept |
| 2 | | name = Prescribing information | 2 | | name = Prescribing information |
| + | 3 | | subtitle = Drug regulation | |
| 3 | | Also called = Label; summary of product characteristics | 4 | | Also called = Label; summary of product characteristics |
| 4 | | Approved by = The medicines regulator | 5 | | Approved by = The medicines regulator |
| ⋮ | ⋮ | ||
| 19 | Warnings and precautions differ from contraindications: a contraindication says the product is not to be used, a warning that a risk exists and is to be managed. Conflating them overstates the restriction. See [[Contraindications of incretin therapy]].{{r|fda_labeling}} | 20 | Warnings and precautions differ from contraindications: a contraindication says the product is not to be used, a warning that a risk exists and is to be managed. Conflating them overstates the restriction. See [[Contraindications of incretin therapy]].{{r|fda_labeling}} |
| 20 | 21 | ||
| + | 22 | == Uses and limits == | |
| + | 23 | | Question | Does labelling answer it? | | |
| + | 24 | |---|---| | |
| + | 25 | | What is this approved for, here? | Yes | | |
| + | 26 | | What dose, and how escalated? | Yes | | |
| + | 27 | | What did the pivotal trials show? | Yes, as accepted by the regulator | | |
| + | 28 | | Is this suitable for a given person? | No; that is a clinical question | | |
| + | 29 | | What about an unapproved use? | No; off-label use is outside the label | | |
| + | 30 | | What about a research chemical? | No; there is no label | | |
| + | 31 | ||
| + | 32 | The last row is the one relevant to much of this wiki. Material sold for research has no approved labelling, so there is no prescribing information for it, and clinical information about an approved product is not about it.{{r|usp1503}} | |
| + | 33 | ||
| 21 | == References == | 34 | == References == |
| 22 | {{reflist}} | 35 | {{reflist}} |
| 23 | <ref name="fda_labeling">United States Food and Drug Administration, ''Labeling for Human Prescription Drug and Biological Products'' (physician labeling rule requirements).</ref> | 36 | <ref name="fda_labeling">United States Food and Drug Administration, ''Labeling for Human Prescription Drug and Biological Products'' (physician labeling rule requirements).</ref> |
| 24 | <ref name="ema_smpc">European Commission, ''A Guideline on Summary of Product Characteristics'' (Notice to Applicants, Volume 2C).</ref> | 37 | <ref name="ema_smpc">European Commission, ''A Guideline on Summary of Product Characteristics'' (Notice to Applicants, Volume 2C).</ref> |
| + | 38 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 25 | 39 | ||
| 26 | {{DEFAULTSORT:Prescribing information}} | 40 | {{DEFAULTSORT:Prescribing information}} |