Elocon Scalp Lotion

  • Name:

    Elocon Scalp Lotion

  • Company:
    info
  • Active Ingredients:

    Mometasone Furoate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/10/17

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Summary of Product Characteristics last updated on medicines.ie: 27/6/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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1 - 0 of 84 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 27 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Converted the SPC from word document to pdf file format

Updated on 27 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Converted the SPC from word document to pdf file format

 

Updated on 25 June 2019 SmPC

Reasons for updating

  • Improved presentation of SmPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Converted the SPC from word format to pdf file format 

 

Updated on 2 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 October 2017 PIL

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 27 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 27 September 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

The changes include: updates to the SPC in sections 4.4 Special warnings and precautions for use, 4.8 Undesirable effects, 5.1 Pharmacodynamic properties and 10 Date of revision of the text following HPRA approval for a PRAC recommendation for a visual disturbance.

Updated on 19 May 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 19 May 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 17 April 2015 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 – addition of the warning related to the systemic side effects following topical application of corticosteroids
Section 4.8 – addition of the ‘Reporting side effects’ paragraph at the end of the section
Section 10 – last revision date change to March 2015  

Updated on 14 November 2013 SmPC

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

Change to Section 7 - Marketing authorisation holder address

Updated on 11 March 2013 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections updated:  6.5 Container closure

Updated on 21 June 2012 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use

Updated on 20 February 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

amending sections 4.3; 4.4; 4.8

Updated on 17 February 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

To amend  Sections 4.3; 4.4; 4.8

Updated on 15 February 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

To amend sections 4.3; 4.4; 4.8

Updated on 27 April 2011 PIL

Reasons for updating

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

Updated on 19 April 2011 SmPC

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
  • Change to MA holder contact details

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes have been made to sections 7,8 and 10 of theSPC due to a change of ownership  following the merger of Merck Sharp and Dohme with Schering-Plough.

In section 7 the MA Holder address has changed to:

Merck Sharp & Dohme Ireland (Human Health) Limited

Pelham House

South County Business Park

Leopardstown

Dublin 18
Ireland

In section 8 the MA Number has changed to:
PA 1286/35/3

In section 10 the date of revision has changed to:
25 March 2011

Updated on 26 January 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 November 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2 – Addition of the following:

 

            Propylene glycol 30.0% w/v (equivalent to 300mg/g)

 

Section 4.4 – the following sentences have been added at end of section:

 

            ELOCON Scalp Lotion contains propylene glycol which may cause skin irritation.

 

Section 4.8 – The first sentence has been changed

 

From:

Local side effects include burning, pruritis, tingling, stinging and signs of skin atrophy.

 

To:

Local side effects include pruritis, tingling, stinging, application site reactions, bacterial infections, folliculitis, furunculosis, acneiform eruptions and signs of skin atrophy.  

 

Additional local side effects reported infrequently when topical dermatological corticosteroids have been used as recommended include: burning, irritation, dryness, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, miliaria.

 

Section 10 – date of revision of text updated from February 2007 to August 2007

 

Updated on 7 June 2007 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.2
 
From: None known
to: Not applicable
 
Section 6.6
 
From: Not applicable
to: No special requirements
 
Section 9 - updated renewal date
Section 10 - updated date of revision of text

Updated on 28 May 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)