Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products : guidance for industry.: H164-236/2018E-PDF
"Opioids are regulated under the Food and Drugs Act and the Controlled Drugs and Substances Act. A majority of the marketed prescription opioid products are used to treat pain, but some are also used to control moderate to severe cough, to control diarrhea, as anesthetics, and to treat opioid use disorder"--Introduction, p. 1.
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| Department/Agency | Canada. Health Canada. |
|---|---|
| Title | Submission of targeted risk management plans and follow-up commitments for prescription opioid-containing products : guidance for industry. |
| Variant title | Guidance for industry |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | "Effective date May 2, 2018." Title from cover. "Your health and safety ... our priority." Issued also in French under title: Présentation des plans de gestion des risques ciblés et des engagements de suivi pour les produits sur ordonnance à base d’opioïdes : document d’orientation à l’intention de l’industrie. Includes bibliographical references. |
| Publishing information | Ottawa : Health Canada, 2018. |
| Description | iii, 23 p. |
| ISBN | 978-0-660-26580-3 |
| Catalogue number |
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| Departmental catalogue number | Pub.: 180050 |
| Subject terms | Prescription drugs Risk management Industrial policy |
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