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Benylin Chesty Coughs (Original)

Last Updated on eMC 08-Aug-2014 View document  | 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.

Updated on 08-Aug-2014 and displayed until Current

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-Jul-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

Updated on 17-Mar-2010 and displayed until 08-Aug-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-Mar-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.

Updated on 12-May-2009 and displayed until 17-Mar-2010

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-Apr-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

Updated on 21-Aug-2008 and displayed until 12-May-2009

Reasons for adding or updating:

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

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

Legal Category:P

Black Triangle (CHM): NO

Updated on 03-Apr-2008 and displayed until 21-Aug-2008

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

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

Updated on 12-Jun-2007 and displayed until 03-Apr-2008

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

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

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10: change to revision of text

Updated on 29-Sep-2004 and displayed until 12-Jun-2007

Reasons for adding or updating:

  • Improved Electronic Presentation

Updated on 16-Jan-2004 and displayed until 29-Sep-2004

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Updated on 26-Sep-2002 and displayed until 16-Jan-2004

Reasons for adding or updating:

  • Correction of spelling/typing errors

Updated on 16-Sep-2002 and displayed until 26-Sep-2002

Reasons for adding or updating:

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

Updated on 24-Aug-2001 and displayed until 16-Sep-2002

Reasons for adding or updating:

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

Company contact details

McNeil Products Ltd

Company image
Address

Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG

Medical Information e-mail
Medical Information Direct Line

01344 864042

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

diphenhydramine hydrochloride, levomenthol

Legal categories

P - Pharmacy

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