Levothyroxine 100 micrograms per 5 ml oral solution
*Company:
ADVANZ PharmaStatus:
No Recent UpdateLegal 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 24 April 2025
File name
1.3.1 PIL-Generic-Delpharm-IE-English-0052.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - how to report a side effect
Updated on 07 November 2024
File name
1.3.1 SPC-Generic-Delpharm-100-IE-English.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 April 2024
File name
1.3.1 PIL-Generic-Delpharm-Common-English-0049.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Change in the address of the Marketing authorization holder Mercury Pharmaceuticals Limited from “Capital House, 85 King William Street London EC4N 7BL UK” to “Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom.”
Updated on 16 April 2024
File name
100 mcg SmPC - 09-04-2024 - CG.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change in the address of the Marketing authorization holder Mercury Pharmaceuticals Limited from “Capital House, 85 King William Street London EC4N 7BL UK” to “Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom.”
File name
Levothyroxine containing products_ Biotin interference with laboratory tests..pdf
Reasons for updating
- Add New Doc
Updated on 08 August 2023
File name
Levothyroxine Oral Solution_PIL_IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 08 August 2023
File name
Levothyroxine 100 micrograms per 5 ml oral solution_IE_SPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 August 2023
File name
Levothyroxine 100 micrograms per 5 ml oral solution_IE_SPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 December 2021
File name
ELTROXIN_Levothyroxine sodium Oral solution 100mcg5ml_SPC_IE.pdf
Reasons for updating
- Change to section 4 - Clinical particulars
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Type IB, Category C.I.z. variation application to update SmPC and PIL in line with letter received from MHRA for outcome of spontaneous ADR data review (SA 19107531- Levothyroxine and Seizures)
Updated on 30 December 2021
File name
ELTROXIN_Levothyroxine sodium Oral solution_PIL_IE.pdf
Reasons for updating
- New PIL for new product
Updated on 26 February 2020
File name
1-3-1-SPC-100-Eng-IE-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
A National Type IAIN, Category C.I.z to update SmPC section 4.4 and corresponding sections of PIL to include wording as per PRAC recommendation letter dated 03-Oct-2019
Updated on 11 April 2019
File name
190405-spc-100.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
ADVANZ Pharma
Address:
Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United KingdomMedical Information E-mail:
medicalinformation@advanzpharma.comTelephone:
+44 (0)208 588 9131Website:
https://www.advanzpharma.comMedical Information Direct Line:
+353 1800 851 119Customer Care direct line:
+353 1 5294 230