Elfabrio 2 mg/mL concentrate for solution for infusion
*Company:
Chiesi LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)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 10 March 2026
File name
Elfabrio PIL EU-IE_CP0088-3.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to further information section
Updated on 10 March 2026
File name
Elfabrio SmPC EU-IE_CS0130-3.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
HUG7206 Elfabrio Risk Minim HCP Booklet IRE print v4.pdf
Reasons for updating
- Replace File
File name
HUG7206 Elfabrio Patient Carer Booklet IRE print v3.pdf
Reasons for updating
- Replace File
File name
HUG7206 Elfabrio Infusion Booklet IRE print v3.pdf
Reasons for updating
- Replace File
File name
HUG7206 Elfabrio Risk Minim HCP Booklet IRE print v4.pdf
Reasons for updating
- New EDM File
File name
HUG7206 Elfabrio Patient Carer Booklet IRE print v3.pdf
Reasons for updating
- New EDM File
File name
HUG7206 Elfabrio Infusion Booklet IRE print v3.pdf
Reasons for updating
- New EDM File
Updated on 07 June 2024
File name
Elfabrio PIL CP0088-2_IE-NI.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
Updated on 07 June 2024
File name
Elfabrio SmPC IE-NI_CS0130-2.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 May 2023
File name
Elfabrio SmPC EU_CS0130-1.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 May 2023
File name
Elfabrio PIL CP0080-1_EU+GB.pdf
Reasons for updating
- New PIL for new product
Updated on 17 May 2023
File name
Elfabrio SmPC EU_CS0130-1.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Chiesi Limited
Address:
Chiesi Limited, 333 Styal Road, Manchester, M22 5LGMedical Information E-mail:
Medinfo.uk@chiesi.comTelephone:
+44 (0) 161 488 5555 , 1800 817 459Website:
https://www.chiesi.uk.com https://www.chiesimedical.co.ukMedical Information Direct Line:
+44 (0)1748 827 271Stock Availability:
CustomerServices.UK@chiesi.com