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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

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Summary of Product Characteristics last updated on the eMC: 31/10/2011
SPC Rotarix

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 31/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   24-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.2 Instruction for preparation
4.3 Contra-indication:  small modification to Intussusception
4.4 Additional sentence about intussusception:  see Section 4.3 and addition of 'Asia'
5.1 Significant updates with additional Asia study data
10  Updated with new date of revision of text
Updated on 10/06/2011 and displayed until 31/10/2011
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 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.1   Update to where cllinical trial details move to other part of SPC
4.4   Update to clinical trial information
5.1   Update to cllinical trial information
10    Revision date changed
Updated on 17/05/2011 and displayed until 10/06/2011
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 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:   14-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.4 Special warning intussusception
4.8 Updated GI section with information on intussusception
6.6 clarification of instructions for use
9. Date of Renewal
10. Updated with new date of revision of text
Updated on 22/02/2011 and displayed until 17/05/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • 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:   24-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.1 Clarification of age 6 to 24 weeks
4.6 Administrative change in wording( note: the meaning is the same)
4.8 “ reported” replaced with “defined”
5.2 Administrative change in wording( note: the meaning is the same)
10. 24 January 2011
Updated on 19/01/2011 and displayed until 22/02/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.2 Restriction to 24 weeks
4.3 Contra-indication of SCID
4.5 Minor typo on word: concomitant
4.6 Change in title to add Fertility
4.8 Addition under post-marketing of SCID details
10  3 November 2010
Updated on 30/09/2010 and displayed until 19/01/2011
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 10 date of revision of the text
Date of revision of text on the SPC:   30-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.4 Information concerning intussusception
4.8 Revised based on review of safety data from clinical trials and Post Marketing Surveillance
10. Date of approval updated
Updated on 20/04/2010 and displayed until 30/09/2010
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 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Information concerning intussusception

Section 4.8 - Revised based on review of safety data from clinical trials and Post Marketing Surveillance

Section 6.5 - Formatting change

Section 10 - Date of approval updated
Updated on 17/09/2009 and displayed until 20/04/2010
Reasons for adding or updating:
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
section 4.2 - Reference to use in preterm infants

section 4.3 -Removal of previous wording on use in HIV infants

section 4.4 - Wording on use in HIV infants. Removal of previous wording on use in premature children.

section 4.8 -Safety data in preterm infants and infants with HIV

section 5.1 - Immune response in preterm infants

section 6.3 -Revised in-use storage information

section 6.4 - Revised storage information

section 10 - Date of approval updated
Updated on 25/09/2008 and displayed until 17/09/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • 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):   YES

Free-text change information supplied by the pharmaceutical company


Section 1 - Administrative changes

Section 2 - Amendment to excipient statement and administrative changes

Section 4.2 - Administrative changes

Section 4.4 - Amendment to excipient statement and administrative changes

Section 4.6 - Administrative changes

Section 4.8 - Reordering of adverse events and administrative changes

Section 5.1 - Revised pharmaco-therapeutic group

Section 6.1 - Administrative changes

Setion 6.3 - Administrative changes

Section 6.5 - Administrative change

Section 6.6 - Administrative change

Section 10 - date of Commission Decision

 

 
Updated on 21/08/2008 and displayed until 25/09/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   19-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.5 - update to wording regarding concomitant administration of OPV

Section 5.1 - update to include data from 2nd year of study 036

Section 10 - Approval date - 04/07/08
Updated on 05/02/2008 and displayed until 21/08/2008
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 10 date of revision of the text
Date of revision of text on the SPC:   12/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4:  To include a warning on Apnoea
Section 4.8:  To include Apnoea as an Undesirable Effect
Section 10: Approval date of variation
Updated on 22/12/2006 and displayed until 05/02/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Several sections have changed.
Updated on 22/05/2006 and displayed until 22/12/2006
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
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