Steglatro 5 mg and 15 mg film-coated tablets
- Name:
Steglatro 5 mg and 15 mg film-coated tablets
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/06/19
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MSD Ireland (Human Health) Limited
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Company Products
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 June 2019 PIL
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 SmPC
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 PIL
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 SmPC
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 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 11 September 2018 SmPC
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 SmPC
Reasons for updating
- New SmPC 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 PIL
Reasons for updating
- New PIL for new product