ROCALTROL

This brand name is authorized in Austria, Australia, Brazil, Canada, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Croatia, Italy, Japan, Malta, Mexico, Netherlands, Singapore, United Kingdom, United States

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 about Calcitriol

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC code Group title 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)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 2502Q
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 503421040023317
Country: CA Health Products and Food Branch Identifier(s): 00481815, 00481823
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 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
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 23.180-1-04-07
Country: EE Ravimiamet Identifier(s): 1004599, 1675931
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 55973, 55974
Country: FR Base de données publique des médicaments Identifier(s): 61847953
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 22110, 29758
Country: HK Department of Health Drug Office Identifier(s): 05357, 05358
Country: HR Agencija za lijekove i medicinske proizvode Identifier(s): HR-H-153851334, HR-H-630148256
Country: IT Agenzia del Farmaco Identifier(s): 024280012, 024280024
Country: JP 医薬品医療機器総合機構 Identifier(s): 3112004M1023, 3112004M2020, 3112402A1020, 3112402A2027
Country: MT Medicines Authority Identifier(s): AA565/48301, AA729/01902
Country: MX Comisión Federal para la Protección contra Riesgos Sanitarios Identifier(s): 341M80
Country: NL Z-Index G-Standaard, PRK Identifier(s): 16608, 16616
Country: SG Health Sciences Authority Identifier(s): 03865P
Country: US FDA, National Drug Code Identifier(s): 30698-143, 30698-144, 30698-911

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