ONE-ALPHA

This brand name is authorized in Canada, Cyprus, Germany, Estonia, Hong Kong, Ireland, Lithuania, Malta, New Zealand, Romania, Singapore, United Kingdom, South Africa

Active ingredients

The drug ONE-ALPHA contains one active pharmaceutical ingredient (API):

1 Alfacalcidol
UNII URQ2517572 - ALFACALCIDOL

Alfacalcidol is Vitamin D-hormone analog (an active metabolite of Vitamin D), which performs important functions in regulation of the calcium balance and the bone metabolism and is activated by the enzyme 25-hydroxylase (converted rapidly in the liver to 1,25-dihydroxyvitamin D) for systemic and in osteoblasts for local D-hormone actions.

Read about Alfacalcidol

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
ONE-ALPHA Solution for injection Medicines & Healthcare Products Regulatory Agency (GB) MPI, EU: SmPC
ONE-ALPHA 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
A11CC03 Alfacalcidol 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 A11CC03

Authorization and marketing

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

Country Identification scheme Identifier(s)
Country: CA Health Products and Food Branch Identifier(s): 00474517, 00474525, 02240329, 02242502
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 00903601, 01670010, 02399207, 02399213, 02399242, 02699398, 03772269, 03913764, 06846005, 09717892
Country: EE Ravimiamet Identifier(s): 1618129
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 162179, 196190, 20066, 20092, 20097, 20102, 20123, 24738, 374166, 374445, 381576
Country: HK Department of Health Drug Office Identifier(s): 45830
Country: IE Health Products Regulatory Authority Identifier(s): 37461, 37478, 72488, 72517, 72523, 72560
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1001449, 1002805, 1081250
Country: MT Medicines Authority Identifier(s): MA1456/00201, MA1456/00202
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 2969, 2973, 9871
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W68102001, W68102002
Country: SG Health Sciences Authority Identifier(s): 05971P, 05972P, 05974P, 06140P, 11062P
Country: ZA Health Products Regulatory Authority Identifier(s): M/22.1.4/0261

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