Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen
*Company:
Novo Nordisk LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)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 28 July 2026
File name
Wegovy SmPC_IE_v9_Jul2026_cl.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- 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
Section 1: Addition of Wegovy 7.2mg SDD
Section 2: Addition of Wegovy 7.2mg SDD
Section 4.1: Minor text changes
Section 4.2: Addition of information on switching from oral to subcutaneous and information for patients with diabetes, along with other minor text changes.
Section 4.4: Minor text changes
Section 4.6: Minor text changes
Section 4.8: Changes to wording of adverse events section
Section 5.1: Minor text changes
Section 5.2: Minor text changes
Section 6.5: Minor text changes and addition of 7.2mg
Section 6.6: Minor text changes
Section 8: Addition of MA number for 7.2mg SDD
Section 10: Update to date of revision of the text
Updated on 28 July 2026
File name
Wegovy PIL_FxT_IE_v5_Jul2026_cl.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2: Minor text changes to children & adolescents section
Section 3: Minor text changes
Section 6: Minor text changes, update to date of revision.
Updated on 19 June 2026
File name
Wegovy SmPC_IE_v8_Jun2026_cl.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- 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
Section 1: Addition of pre-filled syringe presentations
Section 2: Addition of pre-filled syringe details
Section 6.1: Addition of pre-filled syringe details
Section 6.3: Addition of pre-filled syringe shelf life
Section 6.4: Addition of pre-filled syringe storage
Section 6.5: Addition of pre-filled syringe container & pack size
Section 6.6: Addition of pre-filled syringe details
Section 8: Addition of pre-filled syringe MA numbers
Section 10: Date of revision of the text
Updated on 02 April 2026
File name
Wegovy SmPC_IE_v7_Mar2026_cl.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 6.3: Addition of sentence relating to ambient transport.
Updated on 24 March 2026
File name
Wegovy SmPC_IE_v6_Mar2026_cl.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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 6.3: Increase of shelf life for 0.25 mg strength from 2 to 3 years
Section 10: Update to date of revision of the text.
Updated on 18 February 2026
File name
Wegovy SmPC_IE_v5_Feb2026_cl.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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
Section 4.2: Addition of information relating to 7.2 mg dose
Section 4.5: Addition of information relating to 7.2 mg dose & gastric emptying
Section 4.8: Addition of information relating to 7.2 mg dose including sections on hair loss, immunogenicity, dysaesthesia
Section 5.1: Addition of clinical efficacy and safety data relating to 7.2 mg dose. Update to table numbers.
Section 5.2: Addition of absorption data relating to 7.2 mg dose
Section 10: Update to date of revision of the text
Updated on 18 February 2026
File name
Wegovy PIL_IE_v4_Feb2026_cl.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 28 January 2026
File name
Wegovy SmPC_IE_v4_Jan2026_cl.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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to Section 6.3: Increase of shelf-life for single dose device from 1 to 2 years.
Updated on 15 December 2025
File name
Wegovy PIL_IE_v3_Oct2025_cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product looks like and pack contents
Updated on 15 December 2025
File name
Wegovy SmPC_IE_v3_Oct2025_cl.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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 October 2025
File name
Wegovy SmPC_IE_v2_Sep2025_cl.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)
Updated on 02 October 2025
File name
Wegovy PIL_IE_v2_Sep2025_cl.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 05 February 2025
File name
Wegovy SmPC_IE_v1_Oct2024_cl.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 February 2025
File name
Wegovy PIL_IE_v1_Oct2024_cl.pdf
Reasons for updating
- New PIL for new product
Novo Nordisk Limited
Address:
1st Floor, Block A, The Crescent Building, Northwood Business Park, Santry, Dublin 9, IrelandMedical Information E-mail:
infoireland@novonordisk.comTelephone:
+353 1 8629700 ,Fax:
+353 1 8629725Website:
https://www.novonordisk.ie