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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: 26/11/2010
SPC Stugeron 15mg Tablets

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 26/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   23-Nov-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 4.8:

Side effects listed in table along with frequency

Section 5.1:

ATC code added

Section 5.2

More detiled information added for Distribution, Metabolism and Elimination

Section 5.3
Information added where previously no information was available.
Updated on 25/03/2010 and displayed until 26/11/2010
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12-Mar-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 6.3: Shelf life chnaged from 5 to 3 years
Updated on 31/08/2009 and displayed until 25/03/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Cinnarizine

Versions

 
26/11/2010 to Current
25/03/2010 to 26/11/2010
31/08/2009 to 25/03/2010
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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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