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sanofi-aventis

1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.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: 06/01/2011
SPC Anthisan Bite & Sting Cream

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 06/01/2011 and displayed until Current
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 4.3 - Contraindications
  • 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. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   18-Nov-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 1: ammended so that now it states anthisan bite and sting 2% w/w cream

 

Section 2: amended to also state other excipients, now reads:

 

Mepyramine Maleate  2% w/w

 

Also contains:

Castor oil                                              23,60% w/w

Ceto-stearyl alcohol                               13,80% w/w

Propylene glycol 600 monostearate         4,90% w/w

Methyl hydroxybenzoate                        0,20% w/w

 

For a full list of excipients, see section 6.1

 

Section 3: changed to be more specific, now states ‘A smooth off-white cream’

 

Section 4.3- following text added: Hypersensitivity to the active substance or to any of the excipients.

 

Section 4.7: following text added: Anthisan Bite and Sting Cream has minor or moderate influence on the ability to drive and use machines.

 

Section 5.1- ATC code deleted

 

Section 6.1- re-formatted

 

Section 6.3- shelf life has not changed- just amended to read 3 years rather than 36 months

 

Section 6.4- wording changed so that it now reads store below 30 degrees rather than do not store above 30 degrees- advise remains the same

 

Section 6.5- slight change to make it clear that the tube has a screw cap

 

Updated on 03/08/2007 and displayed until 06/01/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   11/2006
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Use of sanofi aventis as a trading style
Updated on 19/09/2005 and displayed until 03/08/2007
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/05/2002 and displayed until 19/09/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
   mepyramine maleate