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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

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?
Summary of Product Characteristics last updated on the eMC: 13/05/2011
SPC Sudafed Blocked Nose Spray

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 13/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-May-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Reason for change: Change to section 1: To register a new name as an alternative, Sudafed Mucus Relief 0.1% Nasal Spray

Updated on 02/12/2010 and displayed until 13/05/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   13-Jan-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Product name has changed from:

Non-Drowsy Sudafed Decongestant Nasal Spray

to:

Sudafed Blocked Nose Spray
Updated on 28/01/2010 and displayed until 02/12/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   13-Jan-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Additional name registered on licence
Updated on 13/05/2009 and displayed until 28/01/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   29-Apr-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To change the wad material composition for the snap-on metered dose spray used in the product from polyethylene to polyethylene/butadiene.

Updated on 27/02/2008 and displayed until 13/05/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   02/2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7: Change of MA holder
Updated on 22/04/2005 and displayed until 27/02/2008
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/09/2004 and displayed until 22/04/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/09/2002 and displayed until 29/09/2004
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  xylometazoline hydrochloride