Meda Pharmaceuticals

Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
Telephone: 0845 460 0000
Fax: 0845 460 0002
Medical Information Direct Line: +44 (0)1748 828 810
Medical Information e-mail: meda@professionalinformation.co.uk
Medical Information Fax: +44 (0)1748 828 801
Out of Hours contact: +44 (0)1748 828 810

Summary of Product Characteristics last updated on the eMC: 11/07/2011
SPC Budelin Novolizer 200 mcg

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 11/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   30-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes 4.4 & 4.8 of the SPC with the risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drug reactions to intranasal corticosteroids
Updated on 20/11/2009 and displayed until 11/07/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes to sections 7., 8., 9., and 10 following change of ownership approval.
Updated on 21/07/2009 and displayed until 20/11/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   01-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change of product name
Updated on 02/09/2008 and displayed until 21/07/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   budesonide