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Sandoz Limited

200 Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Telephone: +44 (0) 1276 698020
Fax: +44 (0) 1276 698324
WWW: http://www.sandoz.com
Medical Information e-mail: sandoz@professionalinformation.co.uk
Medical Information Fax: +44 (0) 1276 698468

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: 05/09/2011
SPC Budesonide 64 micrograms/actuation, Aqueous Nasal 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 05/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Additional text added (in red).

1        NAME OF THE MEDICINAL PRODUCT

 

Budesonide 64 micrograms/actuation, Aqueous Nasal Spray

 

4.4       Special warnings and precautions for use

These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

Updated on 21/02/2011 and displayed until 05/09/2011
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 - MA holder address change from Sandoz ltd, 37 Woolmer way, bordon, Hampshire, GU35 9QE to  Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.United Kingdom.
Updated on 21/12/2009 and displayed until 21/02/2011
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