Migsun 85 mg/500 mg film-coated tablets
*Company:
Orion Pharma (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 10 September 2025
File name
IE Migsun 85 mg_500 mg tabl PIL 010925.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL Section 4
- Addition of adverse reaction ‘Breast pain’ with frequency ‘Rare’
Updated on 10 September 2025
File name
IE Migsun 85 mg_500 mg tabl SPC 010925.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC Section 4.6 Fertility, pregnancy and lactation:
- Addition of following statement to information regarding breastfeeding: ‘Sumatriptan is excreted into breast milk with average relative infant doses of < 4% following administration of a single dose of sumatriptan.’
SPC Section 4.8 Undesirable effects:
- Addition of adverse reaction ‘Breast pain’ with frequency ‘Rare’ to the table of adverse reactions
Updated on 28 May 2025
File name
IE Migsun 85 mg_500 mg tabl SPC 070425.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 May 2025
File name
IE Migsun 85 mg_500 mg tabl SPC 070425.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 February 2025
File name
IE Migsun 85 mg_500 mg tabl SPC 111024.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 February 2025
File name
IE Migsun 85 mg_500 mg tabl PIL 111024.pdf
Reasons for updating
- New PIL for new product
Orion Pharma (Ireland) Ltd
 Ltd.webp)
Address:
c/o Allphar Services Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin D24V06KMedical Information E-mail:
ie.medicalinformation@orionpharma.comWebsite:
https://www.orionpharma.ieMedical Information Direct Line:
+353 1 468 8482Customer Care direct line:
+353 1 428 7777