HEPCLUDEX 2 mg powder for solution for injection
*Company:
Gilead Sciences LtdStatus:
No Recent UpdateLegal 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 17 December 2024
File name
Hepcludex IE& XI SmPC (November 2024).pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 December 2024
File name
Hepcludex IE& XI PIL (November 2024).pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
Updated on 07 November 2024
File name
Hepcludex IE& XI SmPC (October 2024).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004854/II/0034
Updated on 26 July 2023
File name
Hepcludex IE & XI SmPC (July 2023).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 July 2023
File name
Hepcludex IE & XI PIL (July 2023).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 06 April 2023
File name
Hepcludex IE& XI SmPC (March 2023).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2023
File name
Hepcludex IE& XI PIL (March 2023).pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 23 August 2022
File name
Hepcludex IE& XI SmPC (July 2022).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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4 - Clinical particulars
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 August 2022
File name
Hepcludex IE& XI PIL (July 2022).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 14 July 2022
File name
Hepcludex SmPC IE&XI (June 2022).pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 March 2022
File name
Hepcludex SmPC IE-XI (September 2021).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 March 2022
File name
Hepcludex PIL IE-XI (November 2021).pdf
Reasons for updating
- New PIL for new product
Gilead Sciences Ltd
Address:
280 High Holborn, London, WC1V 7EE, UKMedical Information E-mail:
ukmed.info@gilead.comTelephone:
+44 (0)203 681 4500Medical Information Direct Line:
+353 214 825 999 , 08000 113 700 (UK)Customer Care direct line:
+44 (0)203 681 4681