Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK
One-Alpha 1 microgram soft capsules.
One-Alpha 0.25 microgram soft capsules.
One-Alpha 0.5 microgram soft capsules.
| Pharmaceutical Form |
|---|
|
One-Alpha 1 microgram soft capsules: Brown, egg-shaped soft gelatin capsules, holding 0.1 g oily solution. One-Alpha 0.25 microgram soft capsules: Cream-coloured, egg-shaped soft gelatin capsules, holding 0.1 g oily solution. One-Alpha 0.5 microgram soft capsules: Reddish, egg-shaped soft gelatin capsules, holding 0.1 g oily solution. |
Each capsule contains 1 microgram of alfacalcidol.
Each capsule contains 0.25 micrograms of alfacalcidol.
Each capsule contains 0.5 micrograms of alfacalcidol.
Excipient with known effect: Sesame oil.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
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. |
| List of Excipients |
|---|
|
One-Alpha1 microgram soft capsules: Sesame oil One-Alpha0.25 microgram soft capsules: Sesame oil One-Alpha0.5 microgram soft capsules: Sesame oil |
PVC/AL blister of 30 (OP), with polyamide-coated aluminium cover.
LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK
One-Alpha 1 microgram soft capsules: PL 00043/0050
One-Alpha 0.25 microgram soft capsules: PL 00043/0052
One-Alpha 0.5 microgram soft capsules: PL 00043/0206
Date of first authorisation:
One-Alpha 1 microgram soft capsules: 26 January 1978
One-Alpha 0.25 microgram soft capsules: 25 January 1978
One-Alpha 0.5 microgram soft capsules: 22 September 1999
Date of latest renewal:
One-Alpha 1 microgram soft capsules: 7 February 2004
One-Alpha 0.25 microgram soft capsules: 8 November 2006
One-Alpha 0.5 microgram soft capsules: 21 September 2004
| Drug | Countries | |
|---|---|---|
| ONE-ALPHA | Canada, Cyprus, Germany, Estonia, Hong Kong, Ireland, Lithuania, Malta, New Zealand, Romania, Singapore, United Kingdom, South Africa |
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