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McNeil Healthcare (Ireland) Ltd

McNeil Healthcare (Ireland) Ltd
Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316
Summary of Product Characteristics last updated on medicines.ie: 14/09/2009
SPC Benylin Dry Coughs

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 14/09/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Jun-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



Section 4.2:

Indication for use in children under 12 removed.

Section 4.3:

Contraindication not to use in children under 12 added.

Section 10:

Changed to June 2009

Updated on 13/11/2008 and displayed until 14/09/2009
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   10/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Addition of HDPE plastic cap with PE-Alu-PET wad material.
Updated on 25/08/2008 and displayed until 13/11/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   05/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Change in MAh from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire, Co.Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24.
Updated on 16/06/2003 and displayed until 25/08/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Diphenhydramine Hydrochloride
   Dextromethorphan Hydrobromide
   Levomenthol

Versions

 
14/09/2009 to Current
13/11/2008 to 14/09/2009
25/08/2008 to 13/11/2008
16/06/2003 to 25/08/2008
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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