Steglatro 5 mg and 15 mg film-coated tablets * Pharmacy Only: Prescription
Company:
MSD Ireland (Human Health) LimitedStatus:
No Recent UpdateLegal 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