Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: AbbVie Ltd., Maidenhead, SL6 4UB, UK
Zemplar 1 microgram capsules, soft.
| Pharmaceutical Form |
|---|
|
Capsule, soft. 1 microgram capsule: oval, grey soft capsule imprinted with ZA. |
Each capsule of Zemplar 1 microgram contains 1 microgram of paricalcitol.
Excipient with known effect: Each capsule of Zemplar 1 microgram contains 0.71 mg of ethanol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Paricalcitol |
Paricalcitol is a synthetic, biologically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Unlike calcitriol, it is a selective vitamin D receptor (VDR) activator. Paricalcitol reduces parathyroid hormone (PTH) levels by inhibiting parathyroid proliferation and decreasing PTH synthesis and secretion, with minimal impact on calcium and phosphorus levels, and can act directly on bone cells to maintain bone volume and improve mineralization surfaces. |
| List of Excipients |
|---|
|
Capsule contents: Medium chain triglycerides Capsule shell: Gelatin Black Ink: Propylene glycol |
High-density polyethylene (HDPE) bottles closed with child resistant polypropylene caps. Each bottle contains 30 capsules.
PVC/fluoropolymer/aluminium blister strips containing 7 capsules. Each carton contains 1 or 4 blister strips. Packaged in outer cartons containing either 7 or 28 capsules.
Not all pack sizes may be marketed.
AbbVie Ltd., Maidenhead, SL6 4UB, UK
PL 41042/0011
Date of first authorisation: 06 December 2007
Date of latest renewal: 20 January 2012
| Drug | Countries | |
|---|---|---|
| ZEMPLAR | Austria, Brazil, Ecuador, Estonia, Spain, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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