Anthisan Cream
- Name:
Anthisan Cream
- Company:
SANOFI
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20


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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
SANOFI

Company Products
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
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
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 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
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
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
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
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