ONE-ALPHA

This brand name is authorized in Canada, Cyprus, Estonia, Germany, Hong Kong SAR China, Ireland, Lithuania, Malta, New Zealand, Romania, Singapore, South Africa, UK.

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 more about Alfacalcidol

Medication package inserts

Below package inserts are available for further reading:

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