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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

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: 18/04/2011
SPC Ovex/Ovex Family Pack/Boots Threadworm Treatment.

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 18/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12-Apr-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update section 4.8 (Undesirable effects) of the SPC, specifically, to add

dizziness and to change several ADR frequencies in order to bring it line with the

current Company Core Data Sheet.

Updated on 10/01/2011 and displayed until 18/04/2011
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   23-Dec-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to Sections 5.3 Preclinical and 6.6 Special Precautions for Disposal   in line with the Company Core Data Sheet
Updated on 13/12/2010 and displayed until 10/01/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   24-Nov-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Correction to previous version
Updated on 29/11/2010 and displayed until 13/12/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Nov-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 1.

 

Addition of name ‘Threadworm Tablets 2 Years Plus’.
Updated on 18/10/2010 and displayed until 29/11/2010
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 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Sep-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To update Section 4.8 (Undesirable effects) and consequentially Section 4.9

(Overdose) of the SPC in line with the Company Core Data Sheet. Additional

information of results from clinical trials is mentioned and the frequency of ADRs

have been arranged according to MedDRA system organ class. This has been

cross referenced in Section 4.9.

Updated on 22/07/2009 and displayed until 18/10/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   26-Jun-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change in shelf life of the finished product from 60 months to 36 months.
Updated on 17/02/2009 and displayed until 22/07/2009
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-Aug-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Transfer of licence from Janssen-Cilag Ltd to McNeil Products Ltd
Updated on 01/07/2005 and displayed until 17/02/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.9 - Overdose
Updated on 08/11/2004 and displayed until 01/07/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 10 (date of (partial) revision of the text
Updated on 08/03/2004 and displayed until 08/11/2004
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/09/2002 and displayed until 08/03/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 22/08/2001 and displayed until 20/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 27/04/2001 and displayed until 22/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  mebendazole