SUTENT 12.5mg, 25mg, 37.5mg and 50mg Hard Capsules
*Company:
Pfizer Healthcare IrelandStatus:
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 27 March 2024
File name
Adv SPC ST 410 IE clean.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 27 March 2024
File name
Adv PIL ST 400 IE NI clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 February 2023
File name
DEC202154142_Adv SPC ST 40_0 IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 November 2021
File name
Adv PIL ST 39_0 IE NI clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
- Individual PILs superseded by joint PIL
Updated on 17 November 2021
File name
Adv PIL ST 39_0 IE NI clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 09 August 2021
File name
DEC202154142_Adv SPC ST 40_0 IE clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 November 2020
File name
DEC202075202_Adv SPC ST 39_0 IE clean.pdf
Reasons for updating
- 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 10 November 2020
File name
DEC202075202_Adv PIL ST 38_0 IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 30 October 2020
File name
Adv SPC ST 38_0 IE clean.pdf
Reasons for updating
- 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 30 October 2020
File name
Adv PIL ST 37_0 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Updated on 19 November 2019
File name
DEC201964439_Adv PIL ST 36_0 UK IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change of distributor details
Updated on 08 October 2019
File name
DEC201955167_Adv SPC ST 37_0 UK IE clean.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 08 October 2019
File name
DEC201955167_Adv PIL ST 35_0 UK IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 February 2019
File name
Adv PIL ST 34_0 UK IE_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 February 2019
File name
Adv SPC ST 36_0 UK IE_clean.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)
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The SPC has been updated as follows:
Inclusion of the ADR colitis (colitis ischaemic and colitis ulcerative) to the Undesirable Effects Table.
Addition of aortic aneurysms and dissections to Warnings and Precautions section and Undesirable Effects Table.
Updated on 15 January 2019
File name
Adv PIL ST 33_0 UK IE_clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 15 January 2019
File name
Adv SPC ST 35_0 UK IE_clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- 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)
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The SPC has been updated as follows:
Inclusion of pediatric data as a result of the Pediatric Implementation Plan (PIP) in sections 4.2, 4.8, 5.1 and 5.2.
Updated on 23 October 2018
File name
Adv PIL ST 32_0 UK IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 18 October 2018
File name
Adv SPC ST 34_0 UK IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
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SPC section 7: Marketing authorisation holder change to Pfizer EEIG.
Updated on 26 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 26 March 2018
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.5 - 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 4.9 - 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 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 1, 3, 4.1, 4.2, 4.5,4.6, 4.7, 4.9, 5.1, 5.2 and 5.3 , 8 – editorial updates.
Section 4.4 editorial and AE update
Setion 4.8 editorial, AE update, and new information on long term safety.
Updated on 23 March 2018
File name
PIL_11188_639.pdf
Reasons for updating
- New PIL for new product
Updated on 23 March 2018
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
- Correction of spelling/typing errors
Updated on 22 January 2018
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
- 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)
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|
The SPC has been updated as follows: SPC sections 4.5 and 5.2 |
Updated on 22 January 2018
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 25 May 2017
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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The SPC has been updated as follows:
Section 4.1 and 5.1 based on the final CSR of study A6181202.Updated on 24 May 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 18 November 2016
Reasons for updating
- 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 4.4 - 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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
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The SPC has been updated as follows:
Formatting and editorial changes to align with QRD affects Sections: 2, 3, 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 6.1 and 6.6Updated on 11 November 2016
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 29 March 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
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The SPC has been updated as follows:
4.2 Posology and method of administration – subsection on paediatric population updated in line with data.
4.8 Undesirable effects - new section added on paediatric population.
5.1 Pharmacodynamic properties – new section added on paediatric population from Study ADVL0612.
5.2 Pharmacokinetic properties - new section added on paediatric population from Study ADVL0612.
8. MARKETING AUTHORISATION NUMBER(S) – Section updated with the current QRD template.
Updated on 24 March 2016
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 28 July 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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The SPC has been updated as follows:
4.4 Special warnings and precautions for use – new subsection added for Thrombotic Microaniopathy (TMA) and associated data.
4.8 Undesirable effects - updated to include only frequencies in line with CDS and updated to include TMA.
5.1 Pharmacodynamic properties - Minor formatting changes were made throughout document for format consistency i.e. the numbering of tables was corrected
Updated on 23 July 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 20 April 2015
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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The SPC has been updated as follows:
Section 5.1 Pharmacodynamic Properties
Subsection Pancreatic neuroendocrine tumours (pNET) has been updated with new data.Updated on 30 March 2015
Reasons for updating
- Change to MA holder contact details
- Change to improve clarity and readability
Updated on 20 February 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 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.4 Special warnings and precautions for use – cardiac section updated to Replace “myocardial disorders” in the list of cardiovascular events in Section 4.4 with “myocardial ischemia and myocardial infarction”.
QT interval prolongation section updated with safety change.
Section 4.8 Undesirable effects – Updated with new side effects under cardiac disorders section.
Section 4.9 Overdose - Updated to delete ‘A few’ from ‘A few case of overdose have been reported’.Updated on 17 February 2015
Reasons for updating
- Change to date of revision
- Change to side-effects
Updated on 05 September 2014
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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)
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3. PHARMACEUTICAL form
Section corrected to remove “and” from the sentences.
4.2 Posology and method of administration
Information on elderly patients updated in line with CDS.
4.4 Special warnings and precautions for use
Section updated to include statement on hypertension and new information on hypoglycaemia. Also section updated to correct typographic errors.
4.8 Undesirable effects
Section updated with data and changes made to frequency grouping. List of side effect terms have been updated in line with CDS. Statements on endocrine disorders, cardiac disorders, respiratory disorders, gastrointestinal disorders and renal disorders have been deleted. Statement on metabolism and nutrition disorders has been updated to include hypoglycaemic events. Statement on cholecystitis has been deleted under the heptobiliary disorders section.
4.9 Overdose
Section updated to improve clarity and readability.
5.1 Pharmacodynamic properties
Section updated to improve clarity and readability. Also to correct typographic errors.
Updated on 28 August 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 07 August 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updates to Sections 4.8 & 5.3
Updated on 01 August 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 28 February 2014
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)
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Update to sections 4.4 and 4.8 of SPC and PIL regarding necrotizing fasciitis mouth pain, ADR frequency revision and removal of inverted black triangle symbol ▼ next to the pNET indication.
Updated on 25 February 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 18 July 2013
Reasons for updating
- Change to date of revision
- Addition of marketing authorisation holder
Updated on 22 April 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 22 April 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 26 February 2013
Reasons for 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
Legal category:Product subject to medical prescription which may not be renewed (A)
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o Submission of a cumulative review of Nervous System Disorders SOC
o Addition of the ADR “Blood uric acid increase” .
o Revision of existing sections for “Infections”.
o Revision of existing sections for “Skin and tissues disorders,” “Cardiac disorders,” and “Tumour Lysis Syndrome”
o Revision of information for “Heamorrhages” and “Venous Thromboembolic Events”
o Corrections of typos, editorial changes, improvement in the language
Updated on 26 February 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 23 January 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 28 November 2012
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)
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Updated on 02 April 2012
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)
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Updated on 29 March 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 27 January 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 January 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 13 January 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to further information section
- Change to date of revision
- Change to improve clarity and readability
Updated on 01 September 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)
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Section 4.8 – Side effects section table 4 has been updated, the term “not known” has been replaced with “uncommon” and the following heading was added with an additional side effect “Respiratory, thoracic and mediastinal disorders – Uncommon – Haemoptysis”
Updated on 25 August 2011
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to MA holder contact details
Updated on 14 January 2011
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.4 – The following sections were updated; Haematological disorders, Cardiac disorders, QT interval prolongation, thyroid dysfunction, hepatotoxicity and renal function. The following new sections have been added to 4.4; Arterial thromboembolic events, Impaired wound healing and Osteonecrosis of the Jaw (ONJ).
Section 4.5 – Following sentence added “Interaction studies have only been performed in adults.”
Section 4.6 – heading changes only in this section.
Section 4.8
Section 4.9 – The following additional sentence has been added “A few cases of overdose have been reported; these cases were associated with adverse reactions consistent with the known safety profile of sunitinib, or without adverse reactions.”
Section 5.1 – Heading update.
Section 5.3 – The Carcinogenicity section was updated.
Updated on 12 January 2011
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to date of revision
- Change to MA holder contact details
Updated on 07 December 2010
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 07 December 2010
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 03 December 2010
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 13 August 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.2:
Renal Insufficiency section has been updated
Section 5.2:
Special population- Renal impairment section has been updated
Updated on 13 August 2010
Reasons for updating
- Change to further information section
Updated on 04 May 2010
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 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.4: Special warnings and precautions for use
Section 4.8: Undesirable effects
Section 5.1: Pharmacodynamic properties
Section 6.3: Shelf life - change the shelf life of the Sutent capsules from 24 to 36 months.
Updated on 27 April 2010
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 16 November 2009
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 15 September 2009
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)
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Revision of the SmPC,
Section 4.4 to include Hypersensitivity/angioedema and Fistula
Section 4.8, post marketing experience section, to include Hypersensitivity/angioedema and Fistula
Updated on 15 September 2009
Reasons for updating
- Correction of spelling/typing errors
Updated on 07 September 2009
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 16 June 2009
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 6 - Pharmaceutical particulars
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 1: Name of Product with new strength
Section 2: Qualitative and quantitative composition with new strength
Section 3: Pharmaceutical Form with new strength
Section 6: Pharmaceutical Particulars with new strength
Updated on 15 June 2009
Reasons for updating
- Change to further information section
- Introduction of new strength
- Improved electronic presentation
Updated on 20 February 2009
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)
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Pulmonary Events: update to section 4.4
Haematological: update to section 4.4
Venous Thromboembolic Events: update to section 4.4 - adding the fatal events.
Infection and infestations: To update SmPC section 4.8 by adding pneumonia events
Updated on 20 February 2009
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 03 September 2008
Reasons for updating
- Change to side-effects
Updated on 02 September 2008
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)
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4.4 – addition of text under sub-headings, haemorrhage, cardiovascular, QT interval prolongation, hypothyroidism, pancreatic and hepatic function
4.8 – addition of text and reformatting of tables and addition of text to adverse reactions from post-marketing experience
Updated on 05 February 2008
Reasons for updating
- Addition of marketing authorisation holder
- Change due to harmonisation of patient information leaflet
- Change to warnings or special precautions for use
Updated on 04 February 2008
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 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
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4.1 – reformatting
4.2 – Dose adjustments and reformatting
4.4 – addition of text under sub-headings, haemorrhage, gastrointestinal events, hypertension, cardiovascular, QT interval prolongation, hypothyroidism, pancreatic and hepatic function
4.8 – addition of text and reformatting of tables and addition of text to adverse reactions from post-marketing experience
6.5 – description for blister pack added
Updated on 30 August 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 05 July 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 February 2007
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 February 2007
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 February 2007
Reasons for updating
- Change to date of revision
- Addition of joint PIL covering all presentations
- Addition of marketing authorisation holder
Updated on 12 February 2007
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 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
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4.2 Posology and method of administration – Hepatic insufficiency subheading
4.4 Special warnings and precautions for use - QT prolongation and Pancreatic function
4.8 Undesirable effects – last sentence in first paragraph added
5.2 Pharmacokinetic properties organ function impairment
Updated on 07 August 2006
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 August 2006
Reasons for updating
- New PIL for new product