Steglatro 5 mg and 15 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    MSD Ireland (Human Health) Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • 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 13 May 2022

File name

627e1b9b077bc.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 17 November 2021

File name

STEGLATRO-H-C-4315-WS-1953-SPC-IE-en-CRT_1637141861.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC based on results from the VERTIS CV study.

Update to section 6.6 Special precautions for disposal and editorial updates to sections 4.2, 4.4, 4.8, 5.1, 5.2 & 5.3 of the SmPC.

 

Updated on 17 November 2021

File name

QRD-IE-STEGLATRO-LFT-WS-1953-22102021_1637140961.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 August 2020

File name

STEGLATRO-H-C-4315-WS-1825-PIL-IE-en-CRT_1597663960.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to date of revision

Updated on 17 August 2020

File name

STEGLATRO-H-C-4315-WS-1825-SPC-IE-en-CRT_1597663900.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 4.4 of the SmPC regarding sodium.

Update to HPRA details in section 4.8 /  Reporting of suspected adverse reactions.

Updated on 20 November 2019

File name

STEGLATRO-H-C-4315-IG-1157-SPC-IE-en-CRT_1574260788.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 4.4 of the SmPC regarding Diabetic ketoacidosis

Updated on 13 June 2019

File name

STEGLATRO-H-C-4315-WS-1590-PIL-IE-en-CRT_1560429581.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 June 2019

File name

STEGLATRO-H-C-4315-WS-1590-SPC-IE-en-CRT_1560429685.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 4.4 (Special warnings and precautions for use) and section 4.8 (Undesirable effects) of the SmPC regarding Necrotising fasciitis of the perineum (Fournier’s gangrene)

 

Updated on 18 April 2019

File name

STEGLATRO-H-C-4315-PSUSA-00010682-201806-PIL-IE-en-CRT_1555581335.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 18 April 2019

File name

STEGLATRO-H-C-4315-PSUSA-00010682-201806-SPC-IE-en-CRT_1555581459.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 4.4 (Special warnings and precautions for use) of the SmPC to revise the warning on lower limb amputations

 

Updated on 11 September 2018

File name

STEGLATRO_H_C_4315_T_002_PIL_IE_en_CRT_1536657573.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 11 September 2018

File name

STEGLATRO_H_C_4315_T_002_SPC_IE_en_CRT_1536657924.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to Marketing Authorisation Holder name and address in section 7 of the SPC.

Updated on 26 June 2018

File name

STEGLATRO-H-C-4315-IB-001-SPC-IE-en-clean (2).docx

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

New SPC for new product

Updated on 26 June 2018

File name

STEGLATRO-H-C-4315-IB-001-PIL-IE-en-clean (2).pdf

Reasons for updating

  • New PIL for new product