Delstrigo 100 mg/300 mg/245 mg film-coated tablets *
Pharmacy Only: Prescription

Updated on 20 October 2022

File name

635110383973c.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 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 4.4 - deletion of information regarding sexual transmission.

Section 4.6 - update to text regarding HIV transmission in breastfeeding.

Section 5.2 update in unit ng·h/mL to ng•h/mL.

Section 10 – The last date of revision is updated.


Updated on 20 October 2022

File name

63510f14278c7.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 25 August 2022

File name

6307385034e38.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 date of revision is updated

Updated on 25 August 2022

File name

6307375f55b31.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 details, change in date of revision and addition of sentence “Other sources of information”. 

Updated on 26 July 2022

File name

62dfef8c06352.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 26 April 2022

File name

DELSTRIGO-H-C-4746-WS2065-026_SPC-IE-en-Mar2022_1650982923.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

Note:  A number of editorial changes throughout the SPC have been made such as extra space deletions etc.

Updated on 26 April 2022

File name

QRD-IE-MT-DELSTRIGO-WS2065-026-LFT-Mar2022_1650979400.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 October 2021

File name

QRD-IE-MT-DELSTRIGO-IB-019-LFT-Jun2020_1635331520.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 13 July 2020

File name

DELSTRIGO-H-C-4746-IB-019-SPC-en-IE-CRT June 2020 (002)_1594638484.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 4.8 of the SmPC to implement the wording concerning “lactic acidosis” agreed by the PRAC following to the outcome of the PSUR Procedure

 

Updated on 03 January 2020

File name

DELSTRIGO-H-C-4746-IB-010-SPC-en-CRT (002)_1578049013.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

SPC - Update to 96 weeks resistance data table + QRD version 10.1

Updated on 27 September 2019

File name

DELSTRIGO-H-C-4746-IB-008-SPC-en-CRT (002)_1569582262.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

Type IB PRAC Autoimmune Hepatitis

Updated on 27 September 2019

File name

QRD-DELSTRIGO-H-C-04746-IB-008-PIL-IE-MT (002)_1569581963.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

DELSTRIGO-H-C-4746-II-003-PI-en-CRT_1558359604.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 10 May 2019

File name

QRD-DELSTRIGO-H-C-04746-II-001-PIL-IE-MT_1557499846.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 10 May 2019

File name

DELSTRIGO-H-C-04746-II-001-SPC_1557499932.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-DELSTRIGO-H-C-04746-II-001-PIL-IE-MT_1556532163.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 April 2019

File name

DELSTRIGO-H-C-04746-II-001-SPC_1556532041.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