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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.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: 20/04/2012
SPC Betnovate 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 20/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2 

New sections added  on Recalcitrant dermatoses /Patients who frequently relapse; elderly; renal & hepatic impairment.  Contraindication added for children under one year of age.

10.  17 April 2012
Updated on 10/04/2012 and displayed until 20/04/2012
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   30-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.5     New interactions added (none previously)
4.6     Updated with new information on fertility, lactation and pregnancy
4.9     Whole section reworded
10.0   Updated with new date of revision of text
Updated on 15/02/2012 and displayed until 10/04/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 - re-instate the “hypersensitivity” statement in this section
Section 10 - updated date of revision
Updated on 16/11/2011 and displayed until 15/02/2012
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
5.3 - Reproductive toxicity details added

Subcutaneous administration of betamethasone valerate to mice or rats at doses ≥0.1 mg/kg/day or rabbits at doses ≥12 micrograms/kg/day during pregnancy produced foetal abnormalities including cleft palate and intrauterine growth retardation. 

 

The effect on fertility of betamethasone valerate has not been evaluated in animals.



10 - Date of information updated
Updated on 11/07/2011 and displayed until 16/11/2011
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
5.2.  This section has been re-formatted with no additional new information.

10.  Amended with approval date.
Updated on 06/07/2011 and displayed until 11/07/2011
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.7

Section 4.7 of SmPC: updated in line with SmPC guideline for this section.

10.0

 Date of revision
Updated on 18/02/2005 and displayed until 06/07/2011
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
Updated on 10/03/2003 and displayed until 18/02/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 14/08/2001 and displayed until 10/03/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 14/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  betamethasone valerate