Waxsol 0.5% w/v Ear Drops Solution
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 25 October 2022
File name
ie-pl-waxsol-pr2688312 reformulation-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 25 October 2022
File name
ie-spc-waxsol-pr2688312 reformulation-clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 23 August 2021
File name
ie-pl-waxsol-pr2238614-clean-rtq2.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 23 August 2021
File name
ie-spc-waxsol-pr2238614-clean-rtq2.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Updated on 29 September 2020
File name
ie-pl-waxsol-pr2257344-clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 20 August 2019
File name
ie-spc-waxsol-pr1754058-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Supply through pharmacy only
Updated on 13 February 2019
File name
ie-pl-waxsol-mahtransfer-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 12 February 2019
File name
ie-spc-waxsol-mahtransfer-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Supply through pharmacy only
Updated on 24 February 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 24 February 2016
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Changes to all sections only where the result of a correction of a typographical error in spelling of the product name
Updated on 24 February 2016
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Changes to all sections only where the result of a correction of a typographical error in spelling of the product name
Updated on 24 June 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In Section 4.8: ADR statement was added
In Section 10: Date of Revision was changed
In Section 10: Date of Revision was changed
Updated on 24 June 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In Section 4.8: ADR statement was added
In Section 10: Date of Revision was changed
In Section 10: Date of Revision was changed
Updated on 01 June 2011
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
None provided
Updated on 01 June 2011
Reasons for updating
- New SPC for medicines.ie
Free text change information supplied by the pharmaceutical company
None provided
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1