Delstrigo 100 mg/300 mg/245 mg film-coated tablets

Product Information *

  • Company:

    MSD Ireland (Human Health) Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    This medicinal product is subject to additional monitoring.

    *Additional information is available upon request

  • Legal Category:

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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

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