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Anthisan Cream

  • Name:

    Anthisan Cream

  • Company:
    info
  • Active Ingredients:

    Mepyramine Maleate

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 4/12/2017
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1 - 0 of 167 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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 4 December 2017 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Updated on 4 December 2017 SPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 - 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

Section 4.3 added:-

bacterial, parasitic

Section 4.4 added:-

Before prescribing the product any potential malignancies should be excluded.

Section 4.6 added:-

In pregnant animals, administration of corticosteroids can cause abnormalities of foetal development.  The relevance of this finding to human beings has not been established.

Hydrocortisone may pass into human breast milk..

Section 4.6 removed:-

Animal studies have shown teratogenic effects.  To date similar effects have not been shown to occur in man. 

Section 4.8 added:-

contact dermatitis, rash.

adrenal suppression.

Updated on 30 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 November 2017 PIL

Reasons for updating

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

Updated on 21 May 2013 PIL

Reasons for updating

  • Change of manufacturer
  • Change to marketing authorisation holder

Updated on 17 September 2012 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Section 7 updated to include Sanofi as a trading style

Updated on 13 September 2012 PIL

Reasons for updating

  • Change to storage instructions

Updated on 31 August 2009 SPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change storage conditions to Store below 30*C.

Updated on 26 August 2009 PIL

Reasons for updating

  • Change to storage instructions

Updated on 11 August 2009 SPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 2 - Qualitative and quantitative composition

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2 - Addition of 'For a full list of excipients'.
Section 5.1 - Addition of ATC code

Updated on 11 December 2008 SPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 9 December 2008 PIL

Reasons for updating

  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change due to user-testing of patient information
  • Change to side-effects

Updated on 9 December 2008 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to section 4.1, 4.3, 4.6, 4.7, 4.8, 4.9 of SPC.

Updated on 28 July 2008 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

Update Section 7 and Section 10.

Updated on 13 May 2008 SPC

Reasons for updating

  • 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

Update
section 10 Date of revision.

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 13 November 2006 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Update Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Update Section 10 - Change in date of revision

Updated on 13 November 2006 PIL

Reasons for updating

  • Change of licence holder

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 March 2004 SPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 18 July 2003 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Supply through pharmacy only

Updated on 20 June 2003 SPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 13 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only