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Benylin Infant's Cough Syrup

Last Updated on eMC 22-Apr-2016 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 22-Apr-2016 and displayed until Current

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 19-Apr-2016

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 added text “Excipient with known effect: Maltitol liquid (E965)” “the full list” and “section”

Section 4.2 removed “Oral use” and added “Posology”, “Method of administration”, and “For oral use”

Section 4.3 added text “the active substance or to” and “listed in section 6.1”

Section 4.6 added text “Fertility” and replaced the “P” in “Pregnancy” with “p”

Section 4.7 removed “to”, replaced the “N” in “No” with “n”, and added “This medicinal product has” and “on the ability to drive and use machines”

Section 5.1 added text “Pharmacotherapeutic group: Other cough suppressants and expectorants” and removed “The” and “is”

Section 6.6 removed text “Not applicable” and added text “No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Section 10 replaced date with “19 April 2016”

Updated on 01-Jul-2015 and displayed until 22-Apr-2016

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: 25-Jun-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8 - To update Possible Side Effects with ADR reporting statement

Section 10 - Revision text date 25th June 2015

Updated on 06-Aug-2014 and displayed until 01-Jul-2015

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

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

glycerol

Legal categories

GSL - General Sales List

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