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Wyeth Pharmaceuticals
Huntercombe Lane South, Taplow, Maidenhead, Berks, SL6 0PH
Telephone: +44 (0)1628 604 377
Fax: +44 (0)1628 666 368
Medical Information e-mail: EUMEDINFO@Pfizer.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: 02/04/2012
SPC Prevenar 13 suspension for injection

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 02/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   01-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 – Posology and method of administration

Section 5.1 - Pharmacodynamic properties



Updated on 09/11/2011 and displayed until 02/04/2012
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 4.4 - 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 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.1 – Therapeutic indications

Section 4.2 – Posology and method of administration

Section 4.4 – Special warnings and precautions for use

Section 4.5 - Interaction with other medicinal products and other forms of interaction

Section 4.6 - Fertility, pregnancy and lactation

Section 4.8 - Undesirable effects

Section 5.1 - Pharmacodynamic properties

Section 5.3 - Preclinical safety data
Updated on 05/01/2011 and displayed until 09/11/2011
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 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4: addition of subcutaneous use in infants with coagulation disorders

Section 5.1: study results related to subcutaneous administration in infants and children

Section 7: Marketing Authorisation Holder address change


Updated on 21/09/2010 and displayed until 05/01/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8


Updated on 25/05/2010 and displayed until 21/09/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   18-May-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 6.3 Shelf Life
The Shelf Life has been increased from 2 years to 3 years.
Updated on 12/01/2010 and displayed until 25/05/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
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