Levothyroxine 50 micrograms per 5 ml oral solution
*Company:
ADVANZ PharmaStatus:
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 07 November 2024
File name
1.3.1 SPC-Generic-Delpharm-50-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
50mcg - 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 50 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
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 December 2021
File name
ELTROXIN_Levothyroxine sodium Oral solution 50mcg5ml_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 11 April 2019
File name
190405-spc-50.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)