Eltroxin 50 microgram Tablets

*
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 22 December 2023

File name

50mcg SPC IE.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 10 - Date of revision of the text

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

Updated on 22 December 2023

File name

50mcg PIL IE.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - marketing authorisation holder

Updated on 05 August 2022

File name

Levothyroxine sodium Tablet 50 mcg Eltroxin_PA1142028001-IE_SmPC.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

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

Updated on 05 August 2022

File name

Levothyroxine sodium Tablet 50 mcg Eltroxin_PA1142028001-IE_PIL.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 - 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 28 February 2022

File name

ELTROXIN_Levothyroxine sodium Tablet 50mcg _SPC_IE.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Approved test procedure for related substances and reduction in shelf life of finished product

Updated on 14 March 2021

File name

ie-spc.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

Safety and Efficacy information update as per HPRA instruction.

Updated on 14 March 2021

File name

ie-pil.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)