EMEA-002093-PIP02-17-M02 - paediatric investigation plan
calcifediol
PIPHuman
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Key facts
- Invented name
- Rayaldee
- Active substance
- calcifediol
- Therapeutic area
- Endocrine disorders
- Uro-nephrology
- Decision number
- P/0211/2024
- PIP number
- EMEA-002093-PIP02-17-M02
- Pharmaceutical form(s)
- Prolonged-release capsule
- Condition(s) / indication(s)
- Treatment of secondary hyperparathyroidism (SHPT)
- Route(s) of administration
- Oral use
- Contact for public enquiries
Vifor Fresenius Medical Care Renal Pharma France
E-mail: rayaldee_ra@viforpharma.com
Tel. +41 5885 18000- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Ne