Calcifediol
Active ingredient · 2 therapeutic classes
Sold as RAYALDEE
- Drug class
- Vitamin D and Analogues
- Availability
- See label
- Routes
- Oral
- Markets covered
- 2
- Products on record
- 3
Overview
Calcifediol is an active pharmaceutical ingredient in the Vitamin D and Analogues group (A11CC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 2 | May 22, 2026 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
2 products
Uses
Treatment of vitamin D deficiency in adults. Prevention of vitamin D deficiency in adults with identified risks. As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency.
How to take
CACanada· Health Canada
1 product
Uses
RAYALDEE (calcifediol modified-release capsules, 30 mcg) is a vitamin D3 analogue indicated for the treatment of secondary hyperparathyroidism (SHPT) in adults with Stage 3 or 4 chronic kidney disease (CKD) and low serum 25-hydroxyvitamin D levels [less than 75 nmol/L (30 ng/mL) at initiation].
RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis.
Pediatrics Pediatrics (< 18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics Geriatrics (≥ 65 years of age):
Evidence from clinical studies and experience suggests that use of RAYALDEE in the geriatric population is not associated with differences in safety or effectiveness.
Drug interactions
Known interactions involving Calcifediol. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL136210089 · revised May 22, 2026
- [2]Health Canada (DPD) · 02478498 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.