Regulatory PathRegulatory requirements compared

Active substance

Cabergoline

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Bergo0.5 mgTablet · Oral use8 BottleSAR 87.60Generic · PrescriptionJORDAN RIVER PHARMACEUTICAL INDUSTRIESValid
Bergo0.5 mgTablet · Oral use2 BottleSAR 32.15Generic · PrescriptionJORDAN RIVER PHARMACEUTICAL INDUSTRIESValid
DOSTINEX 0.5MG TABLET0.5 mgTablet · Oral use8 BottleSAR 132.80NCE · PrescriptionPFIZERValid
DOSTINEX 0.5MG TABLET0.5 mgTablet · Oral use2 BottleSAR 41.40NCE · PrescriptionPFIZERValid
Dexorolin0.5 mgTablet · Oral use2 BottleSAR 35.20Generic · PrescriptionMed City PharmaValid
Dexorolin0.5 mgTablet · Oral use8 BottleSAR 112.90Generic · PrescriptionMed City PharmaValid
Lovista0.5 mgTablet · Oral use2 JarSAR 36.15Generic · PrescriptionDAR ALDAWAValid
Lovista0.5 mgTablet · Oral use8 JarSAR 117.05Generic · PrescriptionDAR ALDAWAValid
NOSTIFIX 0.5 mg TABLET0.5 mgTablet · Oral use8 BlisterSAR 119.50Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
NOSTIFIX 0.5 mg TABLET0.5 mgTablet · Oral use2 BlisterSAR 37.25Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Stronyx0.5 mgTablet · Oral use8 BlisterSAR 111.20Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Stronyx0.5 mgTablet · Oral use2 BlisterSAR 34.35Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
Indications — CHI Daman Drug Formulary

ACROMEGALY; CUSHING SYNDROME; HYPERPROLACTINEMIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
CABERGOLINE0.5MGtablet · oralSTRIDES PHARMA INTLPrescription29 Dec 2005
CABERGOLINE0.5MGtablet · oralIVAX SUB TEVA PHARMSPrescription7 Mar 2007
CABERGOLINE0.5MGtablet · oralINGENUS PHARMS LLCPrescription1 Aug 2018
CABERGOLINE0.5MGtablet · oralAMNEALPrescription25 Jun 2024
CABERGOLINE0.5MGtablet · oralSOMERSET THERAPS LLCPrescription9 Sep 2024
CABERGOLINE0.5MGtablet · oralRENATAPrescription15 Jun 2026
DOSTINEX0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralPFIZERDiscontinued23 Dec 1996
CABERGOLINE0.5MGtablet · oralIMPAX LABS INCDiscontinued3 Jul 2007
CABERGOLINE0.5MGtablet · oralACTAVIS LABS FL INCDiscontinued21 Apr 2008
CABERGOLINE0.5MGtablet · oralAPOTEX CORPDiscontinued8 Mar 2013
CABERGOLINE0.5MGtablet · oralPHARMOBEDIENTDiscontinued2 Dec 2013

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-CABERGOLINE024558970.5 MGTABLET · ORALAPOTEX INC
DOSTINEX022424710.5 MGTABLET · ORALPFIZER CANADA ULC
JAMP CABERGOLINE025496110.5 MGTABLET · ORALJAMP PHARMA CORPORATION

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCABERGOLINE 0.5 MG TABLET$1.29524per EA23 Sep 2026
NHS Drug TariffCabergoline 1mg tablets£60.7520 tablet1 Oct 2026
NHS Drug TariffCabergoline 2mg tablets£112.1320 tablet1 Oct 2026
NHS Drug TariffCabergoline 500microgram tablets£9.878 tablet1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 18.8. Medicines for disorders of the pituitary hormone system · core
    Other specified benign neoplasm of endocrine glands
    Oral > Solid > tablet: 0.5 mg; 1 mg

Safety signals and safety-related labeling changes

  • US FDA 21 Apr 2025 DOSTINEX — 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

All safety entries for cabergoline →

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.