A
A
A
Home
Organisation
About Us
Mission and Objectives
Directorates and Units
Committees and Working Groups
Annual Reports
Heads of Medicines Agencies
Working at the Malta Medicines Authority
Career Opportunities
Bank and Payment Details
Data and Information
Freedom of Information
Data Protection
Presentations and Publications
Links
Medical Devices and Pharmaceutical Collaboration
Pharmacy Roster
eHealth
Government of Malta
Heads of Medicines Agency
Innovative Medicines Initiative
European Medicines Agency
Legislation
Introduction
Better Regulation
Legislation Documentation
Medicines Act
Medical Device Legislation
EU Legislation
Consultation
Collaboration
Request for Collaborative Agreements
EU & Medicines Authority Consultations
EU & Medicines Authority Consultations
News & Events
News
Press Releases
Circulars
Other News
Past News
Events
Latest Events
Past Events
Online Services
Online Services
Eudrapharm
EU Common Submission Portal
Medicines Authority Notifications
Servizz.gov.mt
Online Applications (E-Forms)
Newsletters
Contact and Connect
On Line Forms
Enquiries and Feedback
Complaints
Complaints related to Advertising of Medicinal Products
Report Product Defect
Report a Side Effect - Adverse Drug Reaction (ADR)
Connect and Share
Engage with us on Facebook
Follow us on LinkedIn
Follow us on Twitter
Connect with us on Google
Watch our videos on YouTube
Find Us
Contact Details
Previous
Next
Patient / Consumer
Know more about Medicines Regulation
Know more about access to medicines which do not have a Marketing Authorisation
Report a Side Effect
Biological and Biosimilar Medicinal Products
How we monitor the safety of medicines
Know more about the Medicines Supply Chain
Know more about Use of Medicines
Information Leaflets on Medicines
Search for your Medicines
Industry
Pharmaceutical Activities and Inspections
Product Quality Defects Reporting
Scientific Advice
Advertising
Registering a product
Pharmacovigilance
Fees
Health Care Professionals
Search Authorised Medicines in Malta
Adverse Drug Reaction Reporting
How we monitor the safety of medicinal products
Safety Information
Clinical Trials
Product Quality Defects Reporting
Medicines supply chain and regulation
Advertising
Home
/ Medicine details
Medicine details
Useful Links
Medical Devices and Pharmaceutical Collaboration
Pharmacy Roster
eHealth
Government of Malta
Heads of Medicines Agency
Innovative Medicines Initiative
European Medicines Agency
Activities
Pharmaceutical Activities and Inspections
Scientific Advice
Recalls and Rapid Alerts
Registration of Medicinal Products
Advertising
Borderline Products
Changes to prescription status
Safety Recalls
BREXIT - Regulatory considerations
Advanced Scientific Initiatives
Cannabis for Medicinal and Research Purposes
Linguistic Checks
Safety
Clinical Trials
Enforcement and Market Surveillance
Cabergoline Aurobindo 0.5 mg tablets
Authorisation details
Product details
Product Name
Cabergoline Aurobindo 0.5 mg tablets
ATC Code
G02CB03
Active Ingredients
CABERGOLINE
0.5 mg
Pharmaceutical Form
TABLET
Therapeutic Class
OTHER GYNECOLOGICALS
Classification
POM
Status
Authorised
Licence number in the source country:
NOT APPLICABLE
Authorization Number:
MA807/11101
Authorization Date:
25/09/2023
Authorization Holder Name:
Aurobindo Pharma (Malta) Limited
Authorization Holder Addresses
Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
Product Information
Patient Information Leaflets:
PIL_MA807 11101
Download
Summary Products Characteristics
SPC_MA807 11101
Download
Public Assessment Report
PAR_MTH0612 001
Download