Meda Pharmaceuticals

Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
Telephone: 0845 460 0000
Fax: 0845 460 0002
Medical Information Direct Line: +44 (0)1748 828 810
Medical Information e-mail: meda@professionalinformation.co.uk
Medical Information Fax: +44 (0)1748 828 801
Out of Hours contact: +44 (0)1748 828 810

Summary of Product Characteristics last updated on the eMC: 26/11/2009
SPC Tasmar 100 mg Tablets

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 26/11/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   02-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Following EMEA approval of a Renewal application SPC and PIL were amended ton 2 October 2009 and changes made to sections:

2QUALITATIVE AND QUANTITATIVE COMPOSITION
4.2 Posology and method administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.8 Undesirable effects
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Updated on 29/05/2009 and displayed until 26/11/2009
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:   22-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Change to section 7. Marketing Authorisation Holder
Change to section 10. Date of the Revision of the Text
Updated on 01/12/2006 and displayed until 29/05/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

section 4.4 of the Summary of Product Characteristics (SPC) to include a statement concerning late onset hepatitis
 
revision of section 4.8 of the SPC in accordance to the SPC guideline (ADRs presented by MedDRA system organ class and inclusion of frequency categories)
Updated on 11/01/2006 and displayed until 01/12/2006
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 23/03/2005 and displayed until 11/01/2006
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
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