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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: 09/03/2010
SPC Acnisal

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 09/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   16-Feb-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.1
The following text has been removed :
Acusol OP301 
It has been replaced with:
Acrylic styrene copolymer
Updated on 25/07/2008 and displayed until 09/03/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   07/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.1 - changed from Lauramide DEA (monoamide 716) to Lauramide DEA
Updated on 03/06/2008 and displayed until 25/07/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   05/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.1 -  Macrogol 7 Glycerol Cocoate has been converted back to PEG-7 Glyceryl Cocoate
Updated on 17/01/2008 and displayed until 03/06/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
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 1: now reads
Acnisal 2%w/w Cutaneous Solution
 
Section 2: now reads

Salicylic Acid 2.0% w/w.

 

For a full list of excipients, see Section 6.1.

 
Section 6.1: now reads

Purified water

Benzyl alcohol

Sodium chloride

Sodium C14-C16 olefin sulphonate

Lauramide DEA (monoamide 716)

Macrogol 7 Glycerol Cocoate

Acusol OP301 (styrene/acrylate copolymer)
 
Section 6.4: now reads
Store below 25oC.  Store in the original bottle.
 
Section 6.5: now reads

Acnisal is supplied in a white HDPE bottle with a white polypropylene screw cap.  Each bottle contains either 30ml or 177ml of Acnisal.

 

Not all pack sizes may be marketed.

 

 
Updated on 31/07/2007 and displayed until 17/01/2008
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 10- change to date of revision
Updated on 05/02/2007 and displayed until 31/07/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01/2007
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company
Section 6.1 
Lytron 614 (styrene/acrylate copolymer, octoxynol-9 and sodium dodecylbenzene sulphonate).
Has been removed from the list of excipients, and Acusol OP301 has been added.

 
Updated on 12/09/2006 and displayed until 05/02/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2005
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

7.  MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire, SN15 2BB

UK England
 
 

9.     DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 Date of first authorisation: 22 December 1992

 Date of last renewal: 22 Dec 2002
 
Updated on 09/08/2004 and displayed until 12/09/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Salicylic Acid