Soolantra 10 mg/g Cream *
Pharmacy Only: Prescription

Updated on 22 June 2022

File name

62b3221801378.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

629c7b22ad0ba.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_1597664453.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 06 August 2020

File name

Soolantra Cream SPC IE Jun 20_1596714457.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_PA22743-015-001_10062019142919_1563979614.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

In Section 4.8 - addition of contact dermatitis

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

Erythema added as an adverse event with unknown frequency

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

None provided

Updated on 03 June 2015

Reasons for updating

  • New PIL for new product