Levothyroxine 100 micrograms per 5 ml oral solution * Pharmacy Only: Prescription
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 30 December 2021
File name
ELTROXIN_Levothyroxine sodium Oral solution 100mcg5ml_SPC_IE_1640859236.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_1640859192.pdf
Reasons for updating
- New PIL for new product
Updated on 26 February 2020
File name
1-3-1-SPC-100-Eng-IE-clean_1582731869.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_1554983600.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)