Levothyroxine 25 micrograms per 5 ml oral solution

*
Pharmacy Only: Prescription
  • Company:

    ADVANZ Pharma
  • Status:

    Updated
  • Legal 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 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

25mcg 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.” 

EDM Updated on 13 March 2024

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 25micrograms per 5ml 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 30 December 2021

File name

ELTROXIN_Levothyroxine sodium Oral solution 25mcg5ml_SPC_IE.pdf

Reasons for updating

  • Other

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-25.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)