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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

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: 30/03/2011
SPC Vermox 100 mg/5 ml oral suspension

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 30/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.9 - Overdose
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   24-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.8 - updated in line with latest CCDS.
Change to section 4.9 - Addition of alopecia and agranulocytosis.
Change to section 10 - 24th March 2011.
Updated on 16/08/2010 and displayed until 30/03/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


 Update SmPC sections 1 (Name of the medicinal product), 2 (Qualitative and quantitative composition), 3 (Pharmaceutical form), 4.1 (Therapeutic indications), 4.2 (Posology and method of administration), 4.4 (Special warnings and precautions for use), 4.6 (Pregnancy and lactation), 4.7 (Effects on ability to drive and use machines), 5.1 (Pharmacodynamic properties), 6.1 (List of excipients), 6.2 (Incompatibilities), 6.5 (Nature and contents of container), 6.6 (Special precautions for disposal) & 8 (Marketing authorisation numbers)  in line with the QRD template.
Updated on 14/05/2010 and displayed until 16/08/2010
Reasons for adding or updating:
  • 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:   11-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.8 - Undesirable Effects

Revised as per latest data; terminology harmonized using MedDRA.

 

Change to section 4.9 - Overdose

Addition of information regarding adverse reactions reported in patients treated at higher dosages for prolonged periods of time.

 

Change to section 10 - Date of revision of the text

11 May 2010
Updated on 03/12/2008 and displayed until 14/05/2010
Reasons for adding or updating:
  • 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:   01-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7 – Marketing Authorisation Holder

Change of address

Change to section 10 – Date of revision of the text

September 2008
Updated on 01/07/2005 and displayed until 03/12/2008
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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 27/05/2004 and displayed until 01/07/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5 - Pharmacological Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 25/05/2004 and displayed until 27/05/2004
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 19/04/2004 and displayed until 25/05/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 23/08/2001 and displayed until 19/04/2004
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 23/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  mebendazole