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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: 03/08/2010
SPC Stugeron 15

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 03/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   27-Jul-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To update section 4.8 (Undesirable effects) of the SPC in line with the Company Core Data Sheet
Updated on 21/07/2010 and displayed until 03/08/2010
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   15-Jul-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Pgrade to Section 5.3 Preclinical Safety Data with more detailed information.
Updated on 25/05/2010 and displayed until 21/07/2010
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-May-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update section 5.2 (Pharmacokinetic properties) of the SPC in line with the Company Core Data Sheet and with the reference product, Stugeron 15mg.

 
Updated on 13/05/2009 and displayed until 25/05/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   05-May-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
reason for change is a change to section 6.3 – shelf life
Updated on 05/02/2009 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:   22-Jan-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of MAH from McNeil Limited, Saunderton, to McNeil Products Limited, Maidenhead
Updated on 17/09/2007 and displayed until 05/02/2009
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

 
  cinnarizine