ROCALTROL

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Ecuador, Estonia, France, Germany, Hong Kong SAR China, Italy, Japan, Malta, Mexico, Netherlands, Singapore, Spain, UK.

Active ingredients

The drug ROCALTROL contains one active pharmaceutical ingredient (API):

1	Calcitriol UNII FXC9231JVH - CALCITRIOL
	Calcitriol is the most active known form of vitamin D3 in stimulating intestinal calcium transport. In physiological amounts it augments the intestinal absorption of calcium and phosphate and plays a significant part in the regulation of bone mineralisation.
	Read more about Calcitriol

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ROCALTROL Soft capsules	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
A11CC04	Calcitriol	A Alimentary tract and metabolism → A11 Vitamins → A11C Vitamin A and D, incl. combinations of the two → A11CC Vitamin D and analogues
Discover more medicines within A11CC04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	2502Q
BR	Câmara de Regulação do Mercado de Medicamentos	503421040023317
CA	Health Products and Food Branch	00481815, 00481823
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00427968, 00427997, 00499778, 00499790, 01415973, 01416004, 02259914, 02259966, 02417572, 02417603, 03996299, 03996307, 04796898, 04796929, 04964166, 04964172, 04964195, 07379853, 07379876, 07379882, 07379899, 07463298, 07463306, 07487695, 07487703, 09916568, 10990009, 11557728, 11709629, 13781832, 15255591, 15266241, 15568404, 16910230, 16910247, 17448259
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	23.180-1-04-07
EE	Ravimiamet	1004599, 1675931
ES	Centro de información online de medicamentos de la AEMPS	55973, 55974
FR	Base de données publique des médicaments	61847953
GB	Medicines & Healthcare Products Regulatory Agency	22110, 29758
HK	Department of Health Drug Office	05357, 05358
HR	Agencija za lijekove i medicinske proizvode	HR-H-153851334, HR-H-630148256
IT	Agenzia del Farmaco	024280012, 024280024
JP	医薬品医療機器総合機構	3112004M1023, 3112004M2020, 3112402A1020, 3112402A2027
MT	Medicines Authority	AA565/48301, AA729/01902
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	341M80
NL	Z-Index G-Standaard, PRK	16608, 16616
SG	Health Sciences Authority	03865P
US	FDA, National Drug Code	30698-143, 30698-144, 30698-911