Soolantra 10 mg/g Cream
*Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.Status:
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 28 November 2022
File name
20221103 Soolantra ie-mockup-pl-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
SmPC (and PIL) updated further to approval, issued 3Nov2022, for Type IAIN Supergroup variation to standardize the Irish MAH address.
Updated on 28 November 2022
File name
20221103 Soolantra ie-spc-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC (and PIL) updated further to approval, issued 3Nov2022, for Type IAIN Supergroup variation to standardize the Irish MAH address.
Updated on 22 June 2022
File name
202102 Soolantra Cream SmPC Ireland - corr 22Jun2022 - clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Correction to MAH address in order to state:
La Défense 4,
20 Avenue André Prothin,
Updated on 05 June 2022
File name
202102 Soolantra Cream SmPC Ireland.pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
SmPC section 9 updated to reflect the common MRP renewal date (22Mar2020). SmPC section 10 updated to reflect HPRA's approval (26Feb2021) for national phase of MRP renewal.
Updated on 17 August 2020
File name
Soolantra leaflet 30g UK & IRE (P26304-6) Nov 19.pdf
Reasons for updating
- Change to marketing authorisation holder
Updated on 06 August 2020
File name
Soolantra Cream SPC IE Jun 20.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 July 2019
File name
Licence_PA22743-015-0012919.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 April 2018
File name
Soolantra.docx
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 April 2018
File name
Soolantra leaflet 30g UK & IRE (P26304-4).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 11 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 May 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 09 May 2017
File name
PIL_16352_232.pdf
Reasons for updating
- New PIL for new product
Updated on 09 May 2017
Reasons for updating
- Change to section 4 - possible side effects
Updated on 19 December 2016
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 24 November 2016
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 18 January 2016
Reasons for updating
- Change of inactive ingredient
- Change to storage instructions
Updated on 09 December 2015
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Carbomer polymer changed to Carbomer
Increase of in-use shelf life from 8 weeks to 6 months
Updated on 08 June 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 June 2015
Reasons for updating
- New PIL for new product