Clinical efficacy and safety: radiopharmaceuticals and diagnostic agents
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
The European Medicines Agency's scientific guidelines on radiopharmaceuticals and diagnostic agents help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
More information is available on the activities of the Oncology European Specialised Expert Community.
Guidelines on the product-specific core SmPC and product leaflet
- Core SmPC and package leaflet for sodium iodide (131 I) for therapeutic use
- Core summary of product characteristics and package leaflet for (68Ge/68Ga) generator
- Core summary of product characteristics (SmPC) and package leaflet for (99Mo/99mTc) generator
- Core summary of product characteristics (SmPC) and package leaflet for fludeoxyglucose (18F)
- Core summary of product characteristics (SmPC) and package leaflet for fluorodopa (18F)
- Core summary of product characteristics and package leaflet for gadopentetate dimeglumine
- Core summary of product characteristics (SmPC) and package leaflet for gadoteric acid
- Core summary of product characteristics (SmPC) and package leaflet for iopamidol 300
- Core summary of product characteristics (SmPC) and package leaflet for iopamidol 370
- Core summary of product characteristics (SmPC) and package leaflet for nanocolloidal technetium (99mTc) albumin
- Core summary of product characteristics (SmPC) and package leaflet for sodium fluoride (18F)
- Core summary of product characteristics (SmPC) and package leaflet for radiopharmaceuticals
- Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc) sestamibi
- Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc) macrosalb