Celsentri film-coated tablets
*Company:
ViiV Healthcare BVStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 November 2024
File name
ie-pl-celsentritabs-issue12draft1.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Type IAin -Celsentri tabs- Manufacture Address (Postcode Change)
Update of Country Rep for Northern Ireland.
Updated on 09 October 2024
File name
ie-pl-combined-celsentritabs-issue11draft1.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update of tablet count for non marketed bottle pack
Updated on 09 October 2024
File name
ie-spc-celsentritabscombined-issue12draft1.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update tablet number for non marketed bottle pack.
Updated on 01 November 2022
File name
ieukni-pl-combined-celsentritabs-issue10draft3-clean-no header.pdf
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update of the revision date.
Updated on 24 August 2022
File name
ieukni-spc-celsentritabscombined-issue11draft2-Clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 August 2022
File name
ieukni-pl-combined-celsentritabs-issue10draft2-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 14 July 2022
File name
ieukni-spc-celsentritabscombined-issue11draft1.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 July 2022
File name
ieukni-pl-combined-celsentritabs-issue10draft1.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 17 September 2021
File name
ieukni-pl-combined-celsentri-issue9draft1.pdf
Reasons for updating
- Change to other sources of information section
Updated on 10 September 2020
File name
ie-spc-celsentritabscombined-issue10draft1.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Section 4.4: to update in line with the revised EMA guideline
- All Sections: Minor editorial amendments in compliance with EMA QRD (10.1)
Updated on 10 September 2020
File name
ie-pl-celsentritabscombined-issue8draft1.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- Section 2: to update excipients labelling in alignment with revised EMA guideline
- All Sections: Minor editorial amendments in compliance with EMA QRD (10.1)
Updated on 13 May 2020
File name
ie-spc-celsentritabscombined-issue9draft1.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 May 2020
File name
ie-pl-celsentritabscombined-issue7draft1.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 12 October 2018
File name
ie-pl-celsentritabscombined-issue6draft1-MED.IE.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 12 October 2018
File name
ie-spc-celsentritabscombined-issue8draft1-MED.IE.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7: MAH transfer
Section 4.8: removal of the UK reporting information as now an IE only SPC.
Updated on 27 September 2018
File name
ukie-spc-celsentritabscombined-issue7draft1 for meds.ie.pdf
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- SmPC Section 4.4 Warnings “Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.”
- SmPC Section 4.8 Undesirable events “Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. (see section 4.4)”
- SmPC section 6.5 Nature and contents of container updated to include the information reflecting the CRSF 'Polyvinyl chloride (PVC) blisters with child-resistant (CR) aluminium/polyethylene terephthalate (PET) lidding foil backing in a carton containing 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets. '
Updated on 01 June 2018
File name
ukie-spc-celsentri.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2018
File name
ukie-spc-celsentritabscombined-issue6draft1.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 April 2018
File name
ukie-spc-celsentritabscombined-issue6draft1.docx
Reasons for 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of sections 4.5 and 5.2 in order to update the data regarding drug metabolising enzymes and drug transporters from several completed in vitro studies and to support the addition of pharmacogenomic information based on final results from study (A4001110), respectively.
4.2, 4.4 and 5.1 Minor changes.
Section 5.1 Updated with information on genotypic resistance.
Section 4.8 (Reporting details) updated to bring in line with EMA Appendix V for UK.
Updated on 19 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 July 2017
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- Change from individual to joint SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Tablets - 150 mg and 300 mg SmPCs have been combined (used to be single SmPCs). Paediatric strengths (75 mg and 25 mg) and data have been incorporated into this combined SmPC as a result of the line extension application. Sections updated:
Section 1, 2, 3, 4.1, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 (Administrative), 5.1, 5.2, 5.3, 6.1, 6.5 and 8.
Updated on 18 July 2017
File name
PIL_14994_652.pdf
Reasons for updating
- New PIL for new product
Updated on 18 July 2017
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Improved presentation of PIL
- Introduction of new strength
Updated on 21 September 2016
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 December 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 06 May 2015
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 01 May 2015
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 07 April 2015
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 – warning in relation to use in Hep B and C patients updated and included a cross reference made to Section 5.1
Section 4.8 – IMB details updated to HPRA
Section 5.1 – Antiviral activity in vitro updated to refer to EMA website for public assessment report; inclusion of data from clinical studies on patients co-infected with Hep B/C
Updated on 01 April 2015
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
- Correction of spelling/typing errors
Updated on 20 May 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update section 4.4 of the SPC in order to include warnings regarding HIV transmission risk in patients
Update section 4.8 regarding reporting of suspected adverse reactions – addition of separate details for UK and Ireland
Updated on 20 May 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 08 November 2013
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - Undesirable effects,
Section 4.9 - Overdose,
Section 5.1 - Pharmacodynamic properties
Updated on 31 October 2013
Reasons for updating
- Improved electronic presentation
Updated on 21 October 2013
Reasons for 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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 4.8 - Undesirable effects
Updated on 18 October 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
Updated on 31 May 2013
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to: Section 4.5 - Interaction with other medicinal products and other forms of interaction
Updated on 30 May 2013
Reasons for updating
- Change to side-effects
Updated on 29 May 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Celsentri 150mg Film-Coated Tablets SPC
· The following text was added to section 4.4 of the SPC with regards to the addition of an IRIS (Immune Reaction Syndrome) Warning
Autoimmune disorders (such as Graves’ disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
· The following text was added to section 4.8, sub-section “Description of selected adverse reactions” of the SPC with regards to the addition of an IRIS (Immune Reaction Syndrome) Warning
Autoimmune disorders (such as Graves’ disease) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
· The approval date was updated in section 10.
Updated on 28 May 2013
Reasons for updating
- Change to side-effects
Updated on 21 August 2012
Reasons for updating
- Change due to harmonisation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change due to harmonisation or user testing of the patient leaflet
Updated on 16 August 2012
Reasons for updating
- Change due to harmonisation of PIL
- Change due to user-testing of patient information
Updated on 31 May 2012
Reasons for updating
- Change to side-effects
Updated on 16 December 2011
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 13 December 2011
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to Section 3 – removal of Pfizer in debossing on tablets
Updated on 15 November 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 19 May 2011
Reasons for updating
- New PIL for new product
Updated on 27 January 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Included the following two new sub-headings:
2.1 General description
2.2 Qualitative and quantitative composition
4.1 Therapeutic indications
4.2 Posology and method of administration
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
5.1 Pharmacodynamic properties
Minor editorial changes; addition of hyphenation of terms such as treatment-experienced, treatment-naïve, co-administration.
4.8 Undesirable effects
· Minor editorial changes; addition of hyphenation of terms such as treatment-experienced, treatment-naïve, co-administration.
· ‘NB’ replaced the asterix * as emphasis on the note at the end of Table 3, to read:
N.B. Adverse reactions captured in table 3 were assessed as possibly related to study drug by investigators
· Added the full term for OBT at the end of Table 4, ro read:
OBT: Optimised Background Therapy
Updated on 13 August 2010
Reasons for 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use
Updated the warning regarding Cardiovascular safety to add the following statements:
In the pivotal studies of treatment experienced patients (MOTIVATE) coronary heart disease events was more common in patients treated with CELSENTRI than with placebo (11 during 609 PY vs 0 during 111 PY of follow-up). In treatment naïve patients (MERIT) such events occurred at a similarly low rate with CELSENTRI and control (efavirenz).
When CELSENTRI was administered to healthy volunteers at doses higher than the recommended dose, cases of symptomatic postural hypotension were seen at a greater frequency than with placebo. However, when CELSENTRI was given at the recommended dose in HIV infected patients in Phase 3 studies, postural hypotension was seen at a similar rate compared to placebo/comparator. Caution should be used when administering CELSENTRI in patients with a history of postural hypotension or on concomitant medicinal products known to lower blood pressure.
Updated the warning regarding Hepatic safety with the following statement:
Hepatobiliary disorders reported in treatment naïve patients were uncommon and balanced between treatment groups (see section 4.8).
Section4.5 Interaction with other medicinal products and other forms of interaction
In Table 2 Interactions and dose recommendations with other medical products, regarding Etravirine and darunavir/ritonavir (maraviroc 150 mg BID), a minor editorial change to include the word ‘with’ in the recommendation, i.e.:
CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with etravirine and PI (except fosamprenavir/ritonavir where the dose should be 300 mg twice daily)
Section 4.6 Fertility, pregnancy and lactation
Updated the heading to include Fertility.
Section 4.8 Undesirable effects
Updated following the review of data from Phase 2b/3 clinical trials (MOTIVATE 1 and MOTIVATE 2) and one study in treatment naïve adult patients (MERIT) infected with CCR5-tropic HIV-1.
Section 5.1 Pharmacodynamic properties
Updated link to EMA website to:
http://www.ema.europa.eu/htms/human/epar/eparintro
Section 7 MARKETING AUTHORISATION HOLDER
Changed from Pfizer to:
ViiV Healthcare UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
Updated on 23 June 2010
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use
Section 5.2 Pharmacokinetic properties
(updates with renal impairment study results)
Section 6.3 Shelf Life (extension to four years)
Updated on 01 February 2010
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 18 November 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
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 25 August 2009
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
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 23 July 2009
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
update section 5.1 of the SPC regarding failure with CXCR4- using virus as requested by the CHMP following the assessment of FU2 012.1
Updated on 12 November 2008
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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 01 April 2008
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 9 Date of First Authorisation/Renewal of the Authorisation
18 September 2007
Updated on 13 December 2007
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)