This brand name is authorized in United States. It is also authorized in Austria, Brazil, Croatia, Ecuador, Estonia, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Mexico, Romania, Singapore, South Africa, Spain, Turkey, UK.
The drug ZEMPLAR contains one active pharmaceutical ingredient (API):
1
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UNII
6702D36OG5 - PARICALCITOL
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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. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ZEMPLAR Capsule, soft | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) | |
| ZEMPLAR Solution for injection | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| H05BX02 | Paricalcitol | H Systemic hormonal preparations, excl. Sex hormones and insulins → H05 Calcium homeostasis → H05B Anti-parathyroid agents → H05BX Other anti-parathyroid agents |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 543715070000817 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 234-MEE-0414, 432-MEE-0914, 870-MEE-0315 |
| EE | Ravimiamet | 1299382, 1299393, 1299405, 1299416, 1299427, 1299438 |
| ES | Centro de información online de medicamentos de la AEMPS | 64974, 68022 |
| GB | Medicines & Healthcare Products Regulatory Agency | 134654, 134657, 311118, 369091 |
| HK | Department of Health Drug Office | 54111, 55258, 55259 |
| HR | Agencija za lijekove i medicinske proizvode | HR-H-316273011, HR-H-374239440, HR-H-799965648 |
| IE | Health Products Regulatory Authority | 88226, 88284 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 6014, 6302, 6649 |
| IT | Agenzia del Farmaco | 036374054, 036374080, 036374130 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1025675, 1025676, 1025677, 1025678, 1026088, 1026089 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 119M2007, 133M2006 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W63198001, W63198002, W63198003, W63198004, W63199001, W63199002, W63199003, W63200001, W63200002, W63200003 |
| SG | Health Sciences Authority | 12200P, 13370P, 13371P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8680656080223, 8680656080230, 8680656080247, 8680656080254, 8680656080261, 8680656080278 |
| US | FDA, National Drug Code | 0074-1658, 0074-4637, 0074-9036, 0074-9037 |
| ZA | Health Products Regulatory Authority | 36/22.1.4/0386, 36/22.1.4/0387 |
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