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Cymex Cream

Last Updated on eMC 22-Sep-2015 View document  | Actavis UK Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 22-Sep-2015 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 24-Aug-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to Section 4.8 to implement the ADR reporting statement into the Summary of Product Characteristics.

Updated on 11-Dec-2012 and displayed until 22-Sep-2015

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: 20-Nov-2012

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To register a change in the specification for the active substance, Urea, from BP to PhEur. Type IA, B.III.2.c)

 

To register a change in the specification for the active substance, Cetrimide, from BP to PhEur. Type IA, B.III.2.c)

 

To register a change in the specification for the active substance, Dimeticone 350, from BP to PhEur. Type IA, B.III.2.c)

 

To register a change in the specification for the active substance, Chlorocresol, from BP to PhEur. Type IA, B.III.2.c)

 Update to SPC sections 2 and 10

Updated on 22-May-2012 and displayed until 11-Dec-2012

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • 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: 08-May-2012

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To update sections 4.3 (Contraindications) and 4.4 (Special warnings and precautions for use) as requested  and recommended by MHRA in a previous submission (Article 61 submission 0028).

Updated on 17-Jan-2011 and displayed until 22-May-2012

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications

Date of revision of text on the SPC: 23-Dec-2010

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 2, 4.1, 4.2, 4.4, 4.6, 4.9 and 5.1 have been updated in line with the CCSI.

Updated on 26-May-2010 and displayed until 17-Jan-2011

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC: 04-May-2010

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To change the name of the product for Boots Own Label Supplier from Boots Lip and Cold Sore Cream to Lip and Cold Sore Relief Cream

Updated on 19-Sep-2008 and displayed until 26-May-2010

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:GSL

Black Triangle (CHM): NO

Company contact details

Company image
Address

Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Fax

+44 (0)1271 346 106

Medical Information e-mail
Telephone

+44 (0)1271 311 200

Medical Information Direct Line

+44 (0)1271 385 257

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

cetrimide, chlorocresol, dimeticone, urea

Legal categories

GSL - General Sales List

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