Pifeltro 100 mg film-coated tablets
*Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 July 2023
File name
PIFELTRO-H-C-4747-R-027-SPC-IE-en-072023.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Removal of black inverted triangle. Editorial changes throughout the other sections of the SPC.
Updated on 21 July 2023
File name
QRD-IE-MT-UKNI-PIFELTRO-LFT-R-027.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 20 October 2022
File name
PIFELTRO-H-C-4747-IG-1535-024-SPC-IE-en-Sept2022-CHMP-HIV-Transmission-Update.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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
Section 4.4 – deletion of information regarding sexual transmission.
Section 4.6 – update to text regarding HIV transmission in breastfeeding.
Section 10 – The last revision date is updated.
Updated on 20 October 2022
File name
QRD-IE-MT-UKNI-PIFELTRO-LFT-IG-1535-024-CRT-FT-Sept-2022.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Deletion of “Passing HIV to others” section and update to text regarding HIV transmission in breastfeeding. Change in date of last revision.
Updated on 26 August 2022
File name
PIFELTRO-H-C-4747-WS2249-022-SPC-IE-en-Jul2022 (clean).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
Section 5.1 - changes related to resistance in cell culture
Section 5.2 – update the lay-out of the unit for AUC from μg.h/mL to μg•h/mL
Section 10 – The last revision date is updated
Updated on 26 August 2022
File name
QRD IE-MT-UKNI-PIFELTRO-LFT-WS-2249-CRT-FT Jul2022.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Change in formatting of marketing authorisation holder and manufacturer and change in date of last revision.
Updated on 25 August 2022
File name
QRD IE-MT-UKNI-PIFELTRO-LFT-WS-2249-CRT-FT Jul2022.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Change in formatting of marketing authorisation holder and manufacturer and change in date of last revision.
Updated on 28 July 2022
File name
QRD IE-MT-UKNI-PIFELTRO-LFT-BRX-NIP clean FT 16-May-2022.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Addition of United Kingdom (Northern Ireland) details to section 4 and section 6 of the PIL.
Updated on 27 April 2022
File name
PIFELTRO-H-C-4747-WS2605-019-SPC-IE-en-Apr2022.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
Section 4.1 & 4.2 – update relates to the addition of paediatric indication
Section 4.8 - update relates to the paediatric population
Section 5.1 & 5.2 – changes relate to the paediatric population
Section 10 – The last revision date is updated
Updated on 27 April 2022
File name
QRD-PIFELTRO-IE-MT-WS2065-019-LFT-Apr2022.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 6 - date of revision
Free text change information supplied by the pharmaceutical company
-
- Change to section 1 - what the product is used for - changes relate to addition of paediatric indication
- Change to section 2 - use in children and adolescents - changes relate to addition of paediatric indication
- Change to section 6 - date of revision - The last revision date is updated.
Updated on 27 July 2020
File name
QRD-PIFELTRO-IB008-LFT-IE-MT-EN (002).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 27 November 2019
File name
PIFELTRO-H-C-4747-IB-008-SPC-en-CRT (002).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Update to 96 weeks resistance data table + QRD version 10.1
Updated on 27 November 2019
File name
PIFELTRO-H-C-4747-IB-008-SPC-en-CRT (002).
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Update to 96 weeks resistance data table + QRD version 10.1
Updated on 27 September 2019
File name
PIFELTRO-H-C-4747-IB-007-SPC-en-CRT (002).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
PRAC Autoimmune Hepatitis
Updated on 27 September 2019
File name
QRD-PIFELTRO-H-C-04747-IB-007-PI-IE-MT (002).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to section 2 – What you need to know – warnings and precautions
Change to section 6 – Revision Date
Updated on 20 May 2019
File name
PIFELTRO-H-C-4747-II-003-PI-en-CRT.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Change to section 5.1 - Pharmacodynamic properties
Change to section 10 - Date of revision of the text
Addition of 96 weeks data P018 P021
Updated on 20 May 2019
File name
PIFELTRO-H-C-4747-II-003-PI-en-CRT.
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Change to section 5.1 - Pharmacodynamic properties
Change to section 10 - Date of revision of the text
Addition of 96 weeks data P018 P021
Updated on 10 May 2019
File name
QRD-PIFELTRO-H-C-04747-II-001-PI-IE-MT.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 10 May 2019
File name
PIFELTRO-H-C-04747-II-001-SPC.pdf
Reasons for updating
- 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
Change to section 10 - Date of revision of the text
Updated on 29 April 2019
File name
QRD-PIFELTRO-H-C-04747-II-001-PI-IE-MT.pdf
Reasons for updating
- New PIL for new product
Updated on 29 April 2019
File name
PIFELTRO-H-C-04747-II-001-SPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New SPC for new product