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Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
Telephone: +44 (0)208 8631 427
Fax: +44 (0)208 863 1426
WWW: http://www.accord-healthcare.eu
Medical Information Direct Line: +44 (0)208 901 3370
Medical Information e-mail: uk@accord-healthcare.com
Customer Care direct line: +44 (0)208 863 1427
Medical Information Fax: +44 (0)208 863 1426

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: 06/03/2014
SPC Pramipexole Accord 0.35mg tablets

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 06/03/2014 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
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   17-Jan-2013
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Updated section 4.4 with the implementation of class labelling for the risk of impulse control disorders. Section 4.8 was updated accordingly. Section 4.8 was also updated include inappropriate antidiuretic hormone secretion as an adverse drug reaction based on post-marketing data and safety information related to cardiac failure. Updated were also made to bring the SPC in line with the most current QRD template. In section 7 the address of the MAH was updated.  
Updated on 11/12/2012 and displayed until 06/03/2014
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:   06-Nov-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 18 months to 24 months.
Updated on 22/02/2012 and displayed until 11/12/2012
Reasons for adding or updating:
  • New SPC for new product
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