Last Updated on eMC 08-08-2014 View medicine  | McNeil Products 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.

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:30-07-2014

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

section 6.3 to change the shelf life from 36 months to 24 months.

Section 10. Date of revision text . 30 July 2014

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:04-03-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change to section 6.5

 

(1) To register an alternative cap 2-piece HDPE plastic child resistant cap fitted with a polyterephthalate ethylene faced aluminium/expanded for the medicinal product as requested by the MHRA.

(2) To register the deletion of obsolete presentations (involving non-CRC caps that are no longer allowable) and pack sizes that are no more appropriate are to be removed.

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:02-04-2009

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update to Childrens Cough and Cold medicinal products as requested by the MHRA:

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON038908

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC:13-08-2008

Legal Category:P

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:01-03-2008

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to MA as a result of integration

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-04-2007

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10: change to revision of text

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text

Reasons for adding or updating:

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