Caprelsa 100mg and 300mg film coated tablets
*Company:
Sanofi GenzymeStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
File name
Caprelsa aRMM - Ireland HCP Guide - Sept 2024.pdf
Reasons for updating
- Replace File
File name
CAPRELSA aRMM - Ireland patient alert card - Sept 2024.pdf
Reasons for updating
- Replace File
File name
Caprelsa aRMM - Ireland - Dosing and Monitoring Guide for Patients - Sept 2024.pdf
Reasons for updating
- Replace File
Updated on 04 October 2023
File name
1.3.1 IE-SPC Caprelsa (1).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 04 October 2023
File name
1.3.2 Mock-up PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
File name
HCP Guide - Caprelsa IE (1).pdf
Reasons for updating
- Add New Doc
File name
Patient Alert Card - Caprelsa IE (1).pdf
Reasons for updating
- Replace File
File name
Dosing Guide - Caprelsa IE.pdf
Reasons for updating
- Replace File
File name
MAT-XU-2204902 CAPRELSA RMM - Patient-Caregiver UK and Ireland guide - Electronic Version (Nov 22).pdf
Reasons for updating
- Add New Doc
File name
CAPRELSA RMM - UK and Ireland patient alert card - Electronic Version (Nov 2022) (5).pdf
Reasons for updating
- Replace File
Updated on 07 March 2023
File name
1.3.1 IE-SPC Caprelsa (4).pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 March 2023
File name
1.3.1 IE-SPC Caprelsa (1).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 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 March 2023
File name
1.3.2 Mock-up PIL (6).pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- 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 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 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 06 December 2022
File name
1.3.1 IE-SPC Caprelsa (1).pdf
Reasons for 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 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 06 December 2022
File name
1.3.2 Mock-up PIL (4).pdf
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 - contraindications
- 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 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- 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 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
File name
MAT-XU-2204912 -Caprelsa RMM -UK and Ireland HCP Guide - Electronic Version (Nov 2022).pdf
Reasons for updating
- Add New Doc
File name
MAT-XU-2204902 CAPRELSA RMM - Patient-Caregiver UK and Ireland guide - Electronic Version (Nov 22).pdf
Reasons for updating
- Replace File
File name
CAPRELSA RMM - UK and Ireland patient alert card - Electronic Version (Nov 2022).pdf
Reasons for updating
- Replace File
Updated on 21 June 2022
File name
1.3.1 IE-SPC Caprelsa.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 June 2022
File name
1.3.2 Mock-up PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- 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
Updated on 24 January 2022
File name
1.3.1 IE-SPC Caprelsa- Wound healing complications + renewal.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 January 2022
File name
1.3.1 IE-PIL text-Caprelsa.pdf
Reasons for updating
- 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 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 January 2022
File name
1.3.2 Mock-up PIL-Waterford (2).pdf
Reasons for updating
- 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 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 03 December 2021
File name
1.3.2 Mock-up PIL-Waterford (1).pdf
Reasons for updating
- 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 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 February 2021
File name
1.3.2 Mock-up PIL-Waterford.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 07 January 2021
File name
1.3.1 SPC-UK (includes IE and MT).pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 January 2021
File name
1.3.1 PIL text-UKIEMT (1).pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 21 November 2019
File name
Caprelsa SPC.pdf
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)
Updated on 21 November 2019
File name
Caprelsa PIL IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
File name
PATIENT ALERT CARD ELECTRONIC CERTIFIED 29.11.2017.pdf
Reasons for updating
- Add New Doc
File name
RMP CAPRELSA PATIENT GUIDE ELECTRONIC CERTIFIED 29.11.17.pdf
Reasons for updating
- Add New Doc
Updated on 04 June 2019
File name
1.3.2 Mock-up PIL-Waterford.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 20 March 2019
File name
PIL Caprelsa IE-MT (UK removed).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 20 March 2019
File name
SPC Caprelsa IE and MT (UK removed).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
-
- Undesirable effects
Summary of the safety profileOverall summary of adverse reactions
The most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache.
Tabulated list of adverse reactionsAdverse reactions during clinical trials
The following adverse reactions have been identified in clinical studies with patients
- Undesirable effects
Description of selected adverse reactions
Events such as Torsades de pointes, Stevens‑Johnson syndrome, erythema multiforme, interstitial lung disease (sometimes fatal) and PRES (RPLS) have occurred in patients treated with vandetanib monotherapy. It is expected that these would be uncommon adverse reactions in patients receiving vandetanib for MTC.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17 February 2012
Date of latest renewal: 15 January 201909 February 2018
Updated on 14 March 2019
File name
PIL Caprelsa 100mg and 300mg SA181.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 14 March 2019
File name
SPC Caprelsa 100mg and 300mg SA181.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
-
- Undesirable effects
Summary of the safety profileOverall summary of adverse reactions
The most commonly reported adverse drug reactions have been diarrhoea, rash, nausea, hypertension, and headache.
Tabulated list of adverse reactionsAdverse reactions during clinical trials
- Undesirable effects
** including two deaths in patients with QTc > 550 ms (one due to sepsis and one due to heart failure)
Description of selected adverse reactions
Events such as Torsades de pointes, Stevens‑Johnson syndrome, erythema multiforme, interstitial lung disease (sometimes fatal) and PRES (RPLS) have occurred in patients treated with vandetanib monotherapy. It is expected that these would be uncommon adverse reactions in patients receiving vandetanib for MTC.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17 February 2012
Date of latest renewal: 15 January 201909 February 2018
10. DATE OF REVISION OF THE TEXT
Updated on 14 January 2019
File name
PIL Caprelsa 100mg and 300mg fc tablets.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 14 January 2019
File name
SPC Caprelsa 100 and 300mg .pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
7. MARKETING AUTHORISATION HOLDER
Genzyme Europe BV
Paasheuvelweg 25,
1105 BP Amsterdam,
The Netherlands,
Tel: +31 (0)35 699 12 00
Fax: +31 (0) 35 694 32 14
Updated on 02 August 2018
File name
SPC-clean.pdf
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.3 of the SmPC to reflect the results from pre-clinical study titled “ZD6474: A 104 Week Carcinogenicity Study by Oral Gavage in Rats
Updated on 06 June 2018
File name
Caprelsa 100mg & 300mg film-coated tablets SPC.docx
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- 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 5.3 Carcinogenicity
Removed:-
- Vandetanib has shown no carcinogenic potential in a transgenic mouse carcinogenicity study.
Added:-
- Vandetanib has shown no carcinogenic potential effect in a 6 month carcinogenicity study in rasH2 transgenic mice. A 2-year carcinogenicity study in rats was impaired by low survival in the high dose female group and limited exposure of the animals to vandetanib; however, no carcinogenic effects were observed in the remaining animals.
Updated on 05 April 2018
File name
PIL_16032_752.pdf
Reasons for updating
- New PIL for new product
Updated on 05 April 2018
Reasons for updating
- Improved presentation of PIL
Updated on 14 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 March 2018
File name
PIL_16032_115.pdf
Reasons for updating
- New PIL for new product
Updated on 14 March 2018
Reasons for updating
- 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 5.1 added:-
Information on overall survival based on the addendum to clinical study report from the study D4200C00058 (cut-off date 2015): An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 versus Placebo in Subjects with Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer. In addition, the Marketing authorisation holder took the opportunity to update the list of local representatives in the Package Leaflet
Updated on 14 March 2018
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 February 2018
Reasons for updating
- Improved presentation of PIL
Updated on 22 December 2016
Reasons for 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 4.6 - Pregnancy and lactation
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Extension of Indication to include paediatric patients aged 5 to 18 with unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC) for Caprelsa; as a consequence, sections 4.1, 4.2, 4.4, 4.6, 4.8, 5.1 and 5.2 of the SmPC are updated. Other minor changes to the SmPC also included aligning to the QRD template.
Updated on 22 December 2016
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - use in children/adolescents
- Change to section 6 - manufacturer
Updated on 22 September 2016
Reasons for updating
- 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 7: MAH has been transferred from AstraZeneca AB to Genzyme Europe B.V.
Updated on 22 September 2016
Reasons for updating
- Change to further information section
- Change to marketing authorisation holder
Updated on 03 February 2016
Reasons for updating
- 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 4.8 - Undesirable effects
- 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 9 - Date of renewal of authorisation
- 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
4.2 Minor editorial- correction of spelling
4.3 Minor editorial update
4.4 minor update to skin reactions text, editorial update and correction of spelling
4.5 minor editorial update and correction of spelling
4.8 minor editorial and correction of spelling
5.1 minor editorial
5.2 minor editorial
5.3 minor editorial
9 date of renewal added
10 revision date amended
Updated on 03 February 2016
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 22 December 2015
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 December 2015
Reasons for 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of renewal of authorisation
- 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 4.3 minor editorial change, correction of spelling
Section 4.4 update to skin reaction sections and minor editorial change (correction in spelling)
Section 4.5 minor editorial change, correction of spelling
Section 5.1 minor editorial change, correction of spelling
Section 5.2 minor editorial change, correction of spelling
Section 9 date of renewal added
Section 10 updated revision date
Updated on 12 May 2015
Reasons for updating
- 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
Section 4.8 – Amendment of MT ADR reporting address in line with latest QRD Appendix V.
Update to date of revision
Updated on 08 May 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 05 November 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.3 - Preclinical safety data
- 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 4.8 Update AE reporting details in line with QRD
Section 5.3 Update with details that Vandetanib has shown no carcinogenic potential in a transgenic mouse carcinogenicity study.
Section 10 Update to date of revision
Updated on 31 October 2014
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 01 July 2014
Reasons for updating
- New SPC for new product
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 July 2014
Reasons for updating
- New PIL for new product