Levothyroxine 100 micrograms per 5 ml oral solution

*
Pharmacy Only: Prescription
  • Company:

    ADVANZ Pharma
  • Status:

    No Recent Update
  • 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 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)