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Novartis Consumer Health
Wimblehurst Road, Horsham, West Sussex, RH12 5AB
Telephone: +44 (0)1403 210 211
Fax: +44 (0)1403 323 919
Medical Information Direct Line: +44 (0)1403 323 046
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1403 218 111
Medical Information Fax: +44 (0)1403 324 024

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: 19/09/2011
SPC Otrivine Adult Measured Dose Sinusitis 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 19/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Aug-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 10

Date change from 4 March 2010 to 31 August 2011
Updated on 01/06/2010 and displayed until 19/09/2011
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:   04-Mar-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1

Addition of:  Otrivine  Adult Metered Dose 0.1% Nasal Spray

 

 

Section 10

Date change from 22 December 2009 to 4 March 2010
Updated on 09/02/2010 and displayed until 01/06/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Dec-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 5.1

‘Xylometazoline has been replaced with ‘Otrivine Adult Measured Dose Sinusitis Spray’.

 

New Paragraph:

In a double-blind, saline solution (Otrisal) controlled study in patients with common cold, the

decongestant effect of Otrivine was significantly superior (p<0.0001) to Otrisal saline solution based on rhinomanometry measurement at 1 hour after administration of the study drugs.

 

 

Section 10

Date change from 6 May 2005 to 22 December 2009
Updated on 07/08/2008 and displayed until 09/02/2010
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  xylometazoline hydrochloride