Last Updated on eMC 22-09-2015 View medicine  | Teva UK Limited 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.

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:24-08-2015

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.

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:20-11-2012

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

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:08-05-2012

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).

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:23-12-2010

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.

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product

Date of revision of text on the SPC:04-05-2010

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

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-01-0001

Legal Category:GSL

Black Triangle (CHM): NO