Active substance
Choline c 11
- US FDA 5
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CHOLINE C-11 | 4-33.1mCi/ML | injectable · intravenous | MCPRF | Prescription | 12 Sep 2012 |
| CHOLINE C-11 | 4-33.1mCi/ML | injectable · intravenous | DECATUR | Prescription | 13 Nov 2015 |
| CHOLINE C-11 | 4-100mCi/ML | injectable · intravenous | UNIV TX MD ANDERSON | Discontinued | 29 Oct 2015 |
| CHOLINE C-11 | 4-33.1mCi/ML | injectable · intravenous | WA UNIV SCH MED | Discontinued | 10 Jan 2017 |
| CHOLINE C-11 | 4-33.1mCi/ML | injectable · intravenous | UCSF RODIOPHARM | Discontinued | 20 Nov 2017 |
Safety signals and safety-related labeling changes
- US FDA 9 Sep 2024 CHOLINE C-11 — safety-related labeling change
Labeling sections changed: Use in Specific Populations
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.