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Alliance Pharmaceuticals Ireland
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Telephone: + 44 (0)1249 466966
Fax: +44 (0)1249 466 977
Medical Information e-mail: medinfo@alliancepharma.co.uk
Summary of Product Characteristics last updated on medicines.ie: 16/08/2010
SPC Aquadrate 10% w/w Cream

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 16/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company


2.                  QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Now includes the following red text:

 

Aquadrate cream contains Urea 10% w/w

 

For a full list of excipients, see section 6.1.

 

6.5              Nature and contents of container

 

Now includes the following red text:

 

Aquadrate is available in tubes of 30g and 100g.

 

Not all pack sizes may be marketed.

 

 

7.                  MARKETING AUTHORISATION HOLDER

 

Now reads:

 

            Alliance Pharmaceuticals Limited

Avonbridge House

2 Bath Road

Chippenham

Wiltshire SN15 2BB

United Kingdom

 

 
Updated on 17/01/2008 and displayed until 16/08/2010
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
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
Section 5.2: now reads
Urea is primarily excreted in the urine. A small amount is also eliminated in sweat.
 
Section 5.3: now reads

In man, doses of up to 80g/day iv or 100g/day p.o urea are considered safe.

 

Whilst only very limited preclinical data is available, there is no evidence to suggest that urea would have teratogenic, carcinogenic or mutagenic potential in therapeutic use.

Updated on 26/05/2006 and displayed until 17/01/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • 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
Updated on 23/06/2003 and displayed until 26/05/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Urea