Diprosalic Scalp Application

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Pharmacy Only: Prescription

Updated on 26 January 2023

File name

IE-Diprosalic Scalp-EN-SPC-20210730-CRT.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 December 2022

File name

QRD-ie-Diprosalic Lotion 100mL-PIL-IAIN Heist Name Change-CRT.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 26 August 2021

File name

IE-Diprosalic Scalp-EN-SPC-20210730-CRT.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 August 2021

File name

QRD-ie- Diprosalic Lotion- PIL-100ml CRT_.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 27 June 2019

File name

Diprosalic SA PRAC 4.4 4.8 Sep 17.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Converted the SPC from word document to pdf file format

 

Updated on 25 June 2019

File name

Diprosalic SA PRAC 4.4 4.8 Sep 17.

Reasons for updating

  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Converted the SPC from word format to pdf file format 

 

Updated on 10 October 2017

File name

PIL_14527_266.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 October 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 10 October 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC change details:  4.4: Visual disturbances and corticosteroid use 4.8: Blurred vision added to list of possible side effects.

Updated on 10 October 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 February 2017

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 March 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • Change to Section 4.8 - Undesirable effects

Updated on 19 March 2015

Reasons for updating

  • Change to side-effects

Updated on 22 April 2014

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • Change to Section 7 - Marketing authorisation holder. IE MAH address changed from Pelham House to Red Oak North  
  • Updated on 22 April 2014

    Reasons for updating

    • Change to MA holder contact details

    Updated on 29 August 2012

    Reasons for updating

    • Change to side-effects

    Updated on 07 August 2012

    Reasons for updating

    • Change to section 4.4 - Special warnings and precautions for use
    • Change to section 4.6 - Pregnancy and lactation
    • Change to section 4.8 - Undesirable effects
    • Change to section 4.9 - Overdose
    • Change to section 10 - Date of revision of the text

    Legal category:Product subject to medical prescription which may not be renewed (A)

    Free text change information supplied by the pharmaceutical company

    4.4 -  addition of warnings and precautions in line with CDS  
    4.6 - update to text in line with CDS
    4.8 -  addition of side effects in line with CDS
    4.9 -  update to text in line with CDS

    Updated on 05 May 2011

    Reasons for updating

    • Change to section 6.3 - Shelf life

    Legal category:Product subject to medical prescription which may not be renewed (A)

    Free text change information supplied by the pharmaceutical company

    Section 6.3 - Reduction in shelf-life from 2 years to 18 months

     

    Updated on 11 April 2011

    Reasons for updating

    • Change to section 7 - Marketing authorisation holder
    • Change to section 8 - MA number
    • Change to section 10 - Date of revision of the text

    Legal category:Product subject to medical prescription which may not be renewed (A)

    Free text change information supplied by the pharmaceutical company

    Update of SmPC as a result of legal entity change to MSD.

    Updated on 08 April 2011

    Reasons for updating

    • Change to date of revision
    • Change to marketing authorisation holder

    Updated on 08 September 2010

    Reasons for updating

    • Change to storage instructions
    • Change to further information section
    • Change to date of revision
    • Correction of spelling/typing errors

    Updated on 19 January 2010

    Reasons for updating

    • New PIL for medicines.ie

    Updated on 14 September 2009

    Reasons for updating

    • Change to section 1 - Name of medicinal product
    • Change to section 6.2 - Incompatibilities
    • Change to section 6.6 - Special precautions for disposal and other handling
    • Change to section 9 - Date of renewal of authorisation
    • Change to section 10 - Date of revision of the text

    Legal category:Product subject to medical prescription which may not be renewed (A)

    Free text change information supplied by the pharmaceutical company

    Section 1


    From: Diprosalic Ointment

    To: Diprosalic 0.05 % w/w + 3 % w/w Ointment

     

    Section 6.2


    From: None stated

    To: Not applicable

     

    Section 6.6

     

    From: Not applicable

    To: No special requirements

     

    Section 9

     

    Date of renewal updated to 16 March 2007

     

    Section 10

     

    Date of revision of text updated to November 2007

     

    Updated on 28 May 2003

    Reasons for updating

    • New SPC for medicines.ie

    Legal category:Product subject to medical prescription which may not be renewed (A)