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McNeil Healthcare (Ireland) Ltd

McNeil Healthcare (Ireland) Ltd
Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316
Summary of Product Characteristics last updated on medicines.ie: 16/06/2010
SPC Anusol Ointment

When a pharmaceutical company changes an SPC or PIL, 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 16/06/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04-Jun-2010
Legal Category:   Supply through general sale

Free-text change information supplied by the pharmaceutical company

Section 2: Relevant excipient details added.
Section 10: Updated to June 2010
Updated on 28/10/2008 and displayed until 16/06/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2008
Legal Category:   general sale

Free-text change information supplied by the pharmaceutical company

Section 4.1:
Phrase "as diagnosed by a doctor" added.
Phrase "as advised by a doctor" added.
 
Section 4.4
"Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder.

 

If symptoms persist or worsen patients should consult their doctor." added.
 
Section 10:
Changed to October 2008
Updated on 01/05/2008 and displayed until 28/10/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Change from Pfizer Consumer Healthcare, Pottery Road ,Dun Laoghaire, Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland.

Updated on 21/12/2005 and displayed until 01/05/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Updated on 10/05/2004 and displayed until 21/12/2005
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 18/08/2003 and displayed until 10/05/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Zinc Oxide
   Bismuth Oxide
   Bismuth Subgallate
   Balsam Peru

Versions

 
16/06/2010 to Current
28/10/2008 to 16/06/2010
01/05/2008 to 28/10/2008
21/12/2005 to 01/05/2008
10/05/2004 to 21/12/2005
18/08/2003 to 10/05/2004
  • Terms & Conditions | 
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  • Contact Us

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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