Inrebic 100 mg hard capsules
*Company:
Bristol-Myers Squibb Pharma EEIGStatus:
UpdatedLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 06 March 2025
File name
ie-spc-clean (26Feb2025).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Inclusion of Low Thiamine Signal
Updated on 06 March 2025
File name
ie-pl-clean (26Feb2025).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Inclusion of Low Thiamine signal
Updated on 17 July 2024
File name
ie-spc-clean (05Jul2024).pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 06 June 2024
File name
ie-spc-clean (30May2024).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Updated on 07 December 2023
File name
ie-spc-clean (30Nov2023).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
To update the Summary of Product Characteristics (SmPC) with data from the clinical pharmacology study, FEDR-CP-004.
Updated on 13 March 2023
File name
ie-PIL-clean (23Feb2023).pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL
Updated on 13 March 2023
File name
ie-SmPC-clean (23Feb2023).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
New SmPC
Bristol-Myers Squibb Pharma EEIG
Address:
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, IrelandMedical Information E-mail:
medical.information@bms.comTelephone:
+353 1 483 3625Medical Information Direct Line:
Freephone 1 800 749 749Stock Availability:
bmscustomer-service.chester@bms.com