Last Updated on eMC 12-01-2018 View medicine  | Pfizer Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:01-06-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows
Section 5.2 has been expanded and repetitions removed.

Reasons for adding or updating:

  • 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

Date of revision of text on the SPC:01-06-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

Sections 4.4 and 4.5 revised to include warnings concerning co-treatment with CYP3A inhibitors

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Date of revision of text on the SPC:01-03-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

CDS update to SPC sections 48, 46, 44, 52, 53 Type II variation

Reasons for adding or updating:

  • Change to section 5.3 - Preclinical safety data

Date of revision of text on the SPC:01-06-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

The SPC has been updated as follows: Section 5.3, adding preclinical information.

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 4.2 - 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 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Date of revision of text on the SPC:01-03-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SPC has been updated as follows:

As described above. Also, the following sections were updated to align with QRD:

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications

Date of revision of text on the SPC:01-08-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



All sections – Updated in line with QRD

Section 4.3 – Updated with the contraindicated use of administration of live, or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.

Reasons for adding or updating:

  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:01-09-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Update to Section 5.2 to add pharmacokinetic information, add headings and re-position text.

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:02-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 Change to MA holder

Section 8 Change to MA number

Section  Change to date of revision

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC:01-09-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.3 updated to reflect the 5 year shelf life.

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC:15-08-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SmPC  - update to section 5.1

Reasons for adding or updating:

  • Change to section 5.2 - Pharmacokinetic Properties

Date of revision of text on the SPC:11-08-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to section 5.2

Reasons for adding or updating:

  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose

Date of revision of text on the SPC:21-06-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Updated sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8 & 4.9

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form

Date of revision of text on the SPC:06-11-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 3
The new product description has been added to the SmPC along with information that the scoreline is not functional

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC:03-04-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.4 – Addition of warning of potential psychiatric side-effects occurring with systemic steroids.

4.8 – Addition of psychiatric side-effects that have been reported with corticosteroids.

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:01-04-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 

4.4 – Addition of warning of potential psychiatric side-effects occurring with systemic steroids.

4.8 – Addition of psychiatric side-effects that have been reported with corticosteroids.

Reasons for adding or updating:

  • Correction of spelling/typing errors

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC:01-07-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 - Change to MAH address

Reasons for adding or updating:

  • Improved Electronic Presentation

Reasons for adding or updating:

  • No reasons supplied