Regulatory PathRegulatory requirements compared

Active substance

Paricalcitol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Calprime5 µ/mlSolution for injection · Intravenous use5 AmpouleSAR 213.10Generic · PrescriptionSPIMACOValid
Paricalcitol Spectro5 µ/mlSolution for injection · Intravenous use5 AmpouleSAR 461.05Generic · PrescriptionALTAIF PHARMACEUTICALS COMPANYValid
Paricalcitol Spectro5 µg/mlSolution for injection · Intravenous use5 AmpouleSAR 230.90Generic · PrescriptionSpectro PharmaValid
Thyritol5 µ/mlSolution for injection · Intravenous use5 AmpouleSAR 248.65Generic · PrescriptionGlenmark Pharmaceuticals LimitedValid
ZEMPLAR 1 mcg Capsule1 µgCapsule · Oral use30 BottleSAR 419.40NCE · PrescriptionAbbvie LimitedValid
ZEMPLAR 2 mcg Capsule2 µgCapsule · Oral use30 BottleSAR 852.45NCE · PrescriptionAbbvie LimitedValid
ZEMPLAR 5 mcg/ml solution for injection5 µ/mlSolution for injection · Intravenous use5 AmpouleSAR 266.40NCE · PrescriptionAbbvie LimitedValid
Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDERS; HYPERPARATHYRODISM

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
ZEMPLAR0.005MG/ML (0.005MG/ML); 0.002MG/ML (0.002MG/ML); 0.01MG/2ML (0.005MG/ML)solution · intravenousABBVIEPrescription17 Apr 1998
PARICALCITOL0.002MG/ML (0.002MG/ML); 0.005MG/ML (0.005MG/ML); 0.01MG/2ML (0.005MG/ML)solution · intravenousSANDOZPrescription27 Jul 2011
PARICALCITOL1MCG; 2MCG; 4MCGcapsule · oralTEVA PHARMS USAPrescription27 Sep 2013
PARICALCITOL1MCG; 2MCG; 4MCGcapsule · oralBIONPHARMAPrescription27 Mar 2014
PARICALCITOL1MCG; 2MCG; 4MCGcapsule · oralCHARTWELL RXPrescription24 Jun 2014
PARICALCITOL1MCG; 2MCG; 4MCGcapsule · oralRISINGPrescription24 Jun 2014
PARICALCITOL1MCG; 2MCG; 4MCGcapsule · oralAMNEAL PHARMSPrescription13 Jan 2016
PARICALCITOL1MCG; 2MCG; 4MCGcapsule · oralAUROBINDO PHARMA LTDPrescription14 Jan 2016
PARICALCITOL0.002MG/ML (0.002MG/ML); 0.005MG/ML (0.005MG/ML); 0.01MG/2ML (0.005MG/ML)solution · intravenousACCORD HLTHCAREPrescription4 Feb 2016
PARICALCITOL1MCG; 2MCG; 4MCGcapsule · oralPHARMAZONEPrescription7 Oct 2016
PARICALCITOL0.002MG/ML (0.002MG/ML); 0.005MG/ML (0.005MG/ML); 0.01MG/2ML (0.005MG/ML)solution · intravenousAMNEAL PHARMS COPrescription9 Mar 2017
PARICALCITOL0.005MG/ML (0.005MG/ML); 0.01MG/2ML (0.005MG/ML)solution · intravenousRISINGPrescription2 Nov 2017
ZEMPLAR1MCG; 2MCG; 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralABBVIEDiscontinued26 May 2005
PARICALCITOL0.002MG/ML (0.002MG/ML); 0.005MG/ML (0.005MG/ML); 0.01MG/2ML (0.005MG/ML)solution · intravenousHOSPIRADiscontinued21 Oct 2014
PARICALCITOL0.002MG/ML (0.002MG/ML); 0.005MG/ML (0.005MG/ML); 0.01MG/2ML (0.005MG/ML)solution · intravenousHIKMA PHARMSDiscontinued18 Nov 2014
PARICALCITOL1MCG; 2MCG; 4MCGcapsule · oralLOTUS PHARM CO LTDDiscontinued24 Feb 2016
PARICALCITOL0.002MG/ML (0.002MG/ML); 0.005MG/ML (0.005MG/ML); 0.01MG/2ML (0.005MG/ML)solution · intravenousCAPLINDiscontinued17 Aug 2016
PARICALCITOL0.01MG/2ML (0.005MG/ML)solution · intravenousEPIC PHARMA LLCDiscontinued16 Oct 2017
PARICALCITOL0.002MG/ML (0.002MG/ML)solution · intravenousRISINGDiscontinued2 Nov 2017
PARICALCITOL0.002MG/ML (0.002MG/ML); 0.005MG/ML (0.005MG/ML); 0.01MG/2ML (0.005MG/ML)solution · intravenousEUGIA PHARMADiscontinued9 Oct 2018

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPARICALCITOL 1 MCG CAPSULE$1.27717per EA23 Sep 2026
US NADACPARICALCITOL 2 MCG CAPSULE$2.58862per EA23 Sep 2026
NHS Drug TariffParicalcitol 1microgram capsules£69.4428 capsule1 Oct 2026
NHS Drug TariffParicalcitol 2microgram capsules£138.8828 capsule1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 17 Jun 2026 PARICALCITOL — safety-related labeling change
    Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Dec 2019 PARICALCITOL — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 17 Oct 2019 PARICALCITOL — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 18 Oct 2016 ZEMPLAR — safety-related labeling change
    Labeling sections changed: Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for paricalcitol →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.