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

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