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)
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
