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ViiV Healthcare UK Ltd
Stockley Park West, Uxbridge, Middlesex,, UB11 1BT, UK
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328

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: 15/12/2011
SPC Celsentri 150mg film-coated 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 15/12/2011 and displayed until Current
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:   22-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 - hepatotoxicity warning
Section 4.8 - hepatic failure added - very rare undesirable effect
Section 10 - date of revision updated
Updated on 12/05/2011 and displayed until 15/12/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   25-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 3 - Reference to Pfizer debossing now removed
Section 10 - Date of revision updated
Updated on 11/03/2011 and displayed until 12/05/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   20-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Minor typographical errors corrected which do not affect the prescribing information.
Date of revision updated.
Updated on 30/07/2010 and displayed until 11/03/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   02-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
4.4 Update to information regarding hepatic/cardiovascular safety
4.6 Update to heading
4.8 Update to whole section
5.1 Table numbers updated
10 Update to date
Updated on 28/06/2010 and displayed until 30/07/2010
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:   05-May-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 7 - MA transfer of address from Pfizer to ViiV

Section 10 - Date update
Updated on 22/06/2010 and displayed until 28/06/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Include Section 4.2: Posoloy and method of adminstration
Section 4.4: Special warnings and precautions for use
Section 5.2: Pharmacokinetic properties
Section 6.3 Shelf life
Updated on 26/01/2010 and displayed until 22/06/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   05-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 5.1 - Amended to omit statement on resistance profile in treatment naive patients.
Updated on 19/11/2009 and displayed until 26/01/2010
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 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   05-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


 4.4 Special Warnings and Precautions

CELSENTRI is not recommended to be used in treatment naïve patients based on the results of a clinical study in this population (see section 5.1).

 Section 5.1 (i.e. end of clinical result-section)

Studies in CCR5-tropic Treatment Naïve Patients

An ongoing randomised, double-blinded study (MERIT), is exploring CELSENTRI versus efavirenz, both in combination with zidovudine/lamivudine (n=721, 1:1). After 48 weeks of treatment, CELSENTRI did not reach non-inferiority to efavirenz for the endpoint of HIV-1 RNA < 50 copies/mL (65.3 vs. 69.3 % respectively, lower confidence bound -10.9%).  More patients treated with CELSENTRI discontinued due to lack of efficacy (43 vs.15) and among patients with lack of efficacy, the proportion acquiring NRTI resistance (mainly lamivudine) was higher in the CELSENTRI arm. Fewer patients discontinued CELSENTRI due to adverse events (15 vs.49).

 6.6 Special precautions for disposal

Any unused product  or waste material should be disposed of in accordance with local requirements.
Updated on 26/08/2009 and displayed until 19/11/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   07-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 4.5 of the SPC has been updated to reflect data obtained from two interactions studies where maraviroc was administered with raltegravir, etravirine or etravirine+darunavir/ritonavir.
Updated on 22/07/2009 and displayed until 26/08/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   08-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Update section 5.1 of the Summary of Product Characteristics (SPC) regarding failure with CXCR4- using virus in patients with CCR5 virus at baseline further to the assessment of follow up data on all patients who failed with CXCR4- or dual-mixed tropism.
Updated on 14/11/2008 and displayed until 22/07/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   31-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Update to SPC section 5.1: revise wording in 'Failure with CCR5-tropic virus' and 'Genotypic resistance' sections.

Update to SPC section 6.3: change shelflife from 2 to 3 years.

Update to SPC section 4.5: revise information on P-glycoprotein.

 
Updated on 31/03/2008 and displayed until 14/11/2008
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 

Section 9         Date of First Authorisation/Renewal of the Authorisation

                         18 September 2007
Updated on 21/11/2007 and displayed until 31/03/2008
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  maraviroc