Orion Pharma (UK) Limited

Oaklea Court, 22 Park Street, Newbury, Berkshire, RG14 1EA
Telephone: +44 (0)1635 520 300
Fax: +44 (0)1635 580 180
Medical Information e-mail: medicalinformation@orionpharma.com
Out of Hours Telephone: +44 (0)1635 520 300

Summary of Product Characteristics last updated on the eMC: 01/09/2011
SPC Easyhaler Beclometasone 200 micrograms/dose inhalation powder

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 01/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   30-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

The SmPC and PL have been updated to include“Risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drugs reactions to intranasal corticosteroids”
Updated on 29/07/2009 and displayed until 01/09/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 10. Date of (partial) revision of the text

Correction of spelling/typographical errors.                   
Updated on 11/02/2009 and displayed until 29/07/2009
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • SPC Retired pending re-submission
Date of revision of text on the SPC:   16-Feb-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

The MA numbers have been updated
Updated on 14/11/2006 and displayed until 11/02/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 11/09/2006 and displayed until 14/11/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
  • Pending awaiting re-submission
  • Pending awaiting re-submission
Updated on 08/09/2006 and displayed until 11/09/2006
Reasons for adding or updating:
  • New SPC for new product
  • Pending awaiting re-submission

Active Ingredients/Generics

 
   beclometasone dipropionate