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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 11/05/2011
SPC Celebrex 100mg & 200mg Capsules

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 11/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • 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:   03-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


7 - MAH changed from Pharmacia Limited to Pfizer Limited

8 - PL numbers revised to PL 00057/1275 (100mg) and PL 00057/1276 (200mg)

9 - date revised to grant date of new licence

10 - date revised

Updated on 02/12/2010 and displayed until 11/05/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   29-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of data to section 5.1 of the SmPC from the CONDOR (Celecoxib versus Omeprazole and Diclofenac for at risk Osteoarthritis and Rheumatoid Arthritis patients) study
Updated on 13/08/2010 and displayed until 02/12/2010
Reasons for adding or updating:
  • 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-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.8 - addition of adverse reactions pulmonary embolism, chest pain
10 - update to date last revised
Updated on 26/04/2010 and displayed until 13/08/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • 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:   24-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.8 - administrative update to ordering of adverse events in line with system order class database

6.1 - addition of non-volatile ink components: shellac & propylene glycol

6.5 - addition of text Not all pack sizes may be marketed

9 - date of last renewal updated to 3rd December 2009

10 - date of revision updated to 24/02/2010
Updated on 25/06/2009 and displayed until 26/04/2010
Reasons for adding or updating:
  • 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:   09-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.4 - addition of bulk pack 5x(10x10)

Section 10 - date of last revision updated
Updated on 21/01/2009 and displayed until 25/06/2009
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:   09-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.4: addition of information about reported cases of severe hepatic reactions

4.8 addition of post-marketing adverse drug reactions: fulminant hepatitis, liver necrosis, acute generalised exanthematous pustulosis and expansion of hepatic failure text to include sometimes fatal or requiring liver transplant
Updated on 11/07/2008 and displayed until 21/01/2009
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
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • Change from BAN to rINN
Date of revision of text on the SPC:   14-Nov-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 27/04/2007 and displayed until 11/07/2008
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 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Section 4.1 addition of ankylosing spondylitis

Section 4.2 addition of posology for ankylosing spondylitis

Section 5.1 addition of ankylosing spondylitis clinical trials summary
Updated on 04/01/2006 and displayed until 27/04/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • 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
Updated on 31/08/2005 and displayed until 04/01/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/02/2005 and displayed until 31/08/2005
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 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 22/10/2004 and displayed until 18/02/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 15/06/2004 and displayed until 22/10/2004
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations

Active Ingredients/Generics

 
  celecoxib