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Wockhardt UK Ltd
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone: +44 (0)1978 661 261
Fax: +44 (0)1978 660 130

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: 01/10/2010
SPC Ondansetron 4mg, 8mg 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 01/10/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   03-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 & 4.2 – indication & information regarding Paediatric populations added.
Section 4.4, 4.5, 4.6, 4.8 & 4.9 – update in line with PSUR work-sharing procedure
Section 4.8 also updated in line with PSUR - addition of a statement regarding rare, transient, cases of ECG changes including QT interval prolongation.  Also the addition of a statement regarding transient cases of blindness.
Updated on 15/09/2008 and displayed until 01/10/2010
Reasons for adding or updating:
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   11-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 - 'CP Pharmaceuticals Ltd' amended to 'Wockhardt UK Ltd'

Section 8 -
4mg - PL 04543/0509 amended to PL 29831/0155
8mg - PL 04543/0510 amended to PL 29831/0156

Section 9 & 10 amended
Updated on 18/09/2007 and displayed until 15/09/2008
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - shelf-life amended from 2yrs to 36 months
Updated on 25/09/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  ondansetron hydrochloride dihydrate