Clinical efficacy and safety: radiopharmaceuticals and diagnostic agents guidelines
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
Romanian is available via eTranslation, the European Commission's machine translation service.
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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