Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml Nasal Spray, Solution
*Company:
Haleon Ireland LimitedStatus:
UpdatedLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 December 2024
File name
spc_ie_otrivineextra_Khone-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 02 December 2024
File name
working-ie-pil-text-Khone-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 26 July 2024
File name
spc_ie_otrivineextra_Khone_Non-CR-Cap_12Oct2023.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 26 July 2024
File name
working-ie_uk_pil-text-Khone_Non-CR-Cap_otrivineextra_12Oct2023.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 September 2022
File name
Otrivine Extra IE PIL June 2022.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 September 2022
File name
MASTER-ukie-pil-otrivineextra-redesign-211124EM approved 08Jul2022.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 June 2022
File name
ukie-mockup-leaflet-rfi1-otrivineextra-redesign-211124EM.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
change to MAH details of UK licence (no impact to IE licence)
Update of logo layout
Updated on 02 November 2021
File name
ukie-mockup-leaflet-otrivineextra-brsUKadd-210920EM.pdf
Reasons for updating
- Change to name of manufacturer
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
change impacting only UK licence only. Irish MAH and manuf information not impacted
Updated on 25 June 2021
File name
ie-spc-otrivin-extra-dual-relief-gds+prac-jun2021-nationalsteps-200226CT-approved23Jun21.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Updated on 25 June 2021
File name
ie-spc-otrivin-extra-dual-relief-gds+prac-jun2021-nationalsteps-200226CT-approved23Jun21.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.3 - Preclinical safety data
Legal category:Supply through pharmacy only
Updated on 25 June 2021
File name
ukie-mockup-pil-otrivineextra-gds-CT.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 4 - possible side effects
Updated on 01 May 2020
File name
ie-spc-otrivin-extra-dual-relief-clean-CRN009F5Q.pdf
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 01 May 2020
File name
ie-pil-otrivine-extra-dual-relief.pdf
Reasons for updating
- New PIL for new product