Vidaza
*Company:
Bristol-Myers Squibb Pharma EEIGStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 11 December 2023
File name
ie-spc-clean (30Nov2023).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Updated on 11 December 2023
File name
ie-pl-clean (30Nov2023).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 03 May 2022
File name
20220428 IE_XI VIDAZA - PIL - clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- Section 2 (Pregnancy, breast-feeding and fertility) is updated accordingly.
- Date f revision is updated from March 2022 to April 2022
Updated on 03 May 2022
File name
20220428 IE_XI VIDAZA - SmPC - clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- 4.2 Posology and method of administration (Non-interchangeability to oral azacitidine)
- 4.6 Fertility, pregnancy and lactation (Prolonged contraception period for WOCBP)
- 5.3 cross ref to section 4.4 updated to section 4.6
- Date of revision updated to Apr 2022
Updated on 01 April 2022
File name
20220328 IE_XI VIDAZA - PIL - 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
- Individual PILs superseded by joint PIL
Free text change information supplied by the pharmaceutical company
PSUR 18 (19-May-2018 to 18-May-2021) - to update the VIDAZA Product Information (PI) with ”differentiation syndrome” frequency “not known” to section 2 and 4 of the PIL
Updated on 01 April 2022
File name
20220328 IE_XI VIDAZA - SmPC - clean.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 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
PSUR 18 (19-May-2018 to 18-May-2021) - to update the VIDAZA Product Information (PI) with ”differentiation syndrome” frequency “not known” to SmPC section 4.8 and to add an additional warning statement to SmPC section 4.4
Updated on 01 April 2022
File name
IE_XI VIDAZA - PIL - 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
- Individual PILs superseded by joint PIL
Updated on 22 November 2021
File name
20211118 IE PIL - clean.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
Change to section 6 of the PIL to update the EU QP batch release site and revision date
Updated on 07 July 2021
File name
20210628 IE PIL - clean.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
Free text change information supplied by the pharmaceutical company
Change to section 4 HPRA ADR reporting info
Change to section 6 - Marketing Authorisation Transfer (MAT) from Celgene Europe B.V. to Bristol-Myers Squibb Pharma EEIG
Updated on 05 July 2021
File name
20210628 IE SPC- clean.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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Change to section 7 - Marketing Authorisation Transfer (MAT) from Celgene Europe B.V. to Bristol-Myers Squibb Pharma EEIG
Updated on 03 March 2021
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
As a result of this variation, the following sections of the SmPC have been updated in addition to minor typographical corrections:
- SmPC Section 4.8 (Undesirable effects) – Addition of ADRs from study AZA-AML-004 (overall consistent with adult population)
- SmPC Section 5.1 (Pharmacodynamic properties) Addition of study description for AZA-AML-004
- SmPC Section 5.2 (Pharmacokinetic properties) Addition of paediatric pharmacokinetic data
Updated on 24 November 2020
File name
ie-spc-clean.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 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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
In section 4.1 (Contraindications), format changes.
In Section 4.2 (Posology and method of administration) format changes and addition of new information on paediatric population data
In section 4.4 (Special warnings and precautions for use) addition of the new wording clinical study instead of clinical trials in subsection “cardiac and pulmonary disease”
In section 4.8 (Undesirable effects), format changes and addition of new information on paediatric population data.
In section 4.9 (Overdose) addition of the new wording clinical study instead of clinical trials
In Section 5.1 (Pharmacodynamic properties), format changes and addition of the new wording clinical study instead of clinical trials in subsection “clinical efficacy and safety”. Addition of new information on paediatric population data
In Section 5.2 (Pharmacokinetic properties), format changes and addition of new information on paediatric population data
In section 5.3 (Preclinical safety data), format changes
In section 6.6 (Special precautions for disposal and other handling), format changes in subsection “calculation of an individual dose”
Updated on 16 April 2019
File name
Vidaza PIL IRE v24 2April2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 April 2019
File name
Vidaza SPC IRE v24 2April2019.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Updated on 20 March 2019
File name
IE Clean PIL.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 15 August 2018
File name
IE PIL Clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 August 2018
File name
IE SPC Clean.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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Change the MAH name and address from Celgene Europe Limited, 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom to Celgene Europe BV, Winthontlaan 6 N, 3526 KV Utrecht, Netherlands.
Updated on 18 July 2018
File name
Vidaza SmPC IE v20.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to restricted prescription (C)
Updated on 01 June 2018
File name
170518_v20.0_Vidaza_EU_PI_IE - Clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 14 May 2018
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to restricted prescription (C)
Updated on 26 April 2018
File name
Vidaza PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
Updated on 18 July 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 18 July 2016
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of SmPC Section 4.1. - removal of age limit in elderly AML indication.
Updated on 14 July 2016
File name
PIL_15091_204.pdf
Reasons for updating
- New PIL for new product
Updated on 14 July 2016
Reasons for updating
- Change to date of revision
Updated on 11 April 2016
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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 07 April 2016
Reasons for updating
- Change to side-effects
Updated on 17 November 2015
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
Updated on 11 November 2015
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 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of 4.1, 4.2, 4.4, 4.8 and 5.1 to add new indication for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.
Updated on 10 November 2015
Reasons for updating
- Change to side-effects
- Changes to therapeutic indications
Updated on 06 March 2015
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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of sections 4.4 and 4.8 to add ADR Necrotising Fasciitis
Updated on 03 March 2015
Reasons for updating
- Change to side-effects
Updated on 17 November 2014
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 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Sections 4.2, 4.4, 4.6, 5.2, and 5.3of the SmPC have been changed to reflect the information on renal impairment and clinical pharmacology data (minor editorial updates were also implemented).
Updated on 07 November 2014
Reasons for updating
- Change due to harmonisation of PIL
- Correction of spelling/typing errors
Updated on 11 August 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 23 July 2014
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 31 January 2014
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - 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 4.8 – 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 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 2 - wording change
Section 4.2
- Paragraph on lab tests changed position
- formatting changes, ie terms now in lower case rathert than capials, such as nadir
- Paragraph on elderly under special populations changed position
Section 4.3 - Formatting changes
Section 4.4 - Formatting changes and azacitidine used rathert than Vidaza
Section 4.6 - Formatting changes
Section 4.7 - Caution recommended when driving or operating machines due to potential fatigue
Section 4.8 - Paragraph regarding most common side effects changes position
Section 4.8 (how to report AEs) - Paragraph added regarding reporting suspected AEs
Section 5.1 - Formatting changes
Section 5.2 - Formatting changes
Section 6.2 - Formatting changes
Section 6.4 - Formatting changes
Section 6.5 - Formatting changes
Section 6.6 - Formatting changes
Section 9 - Altered to 17/12/2013
Section 10 - Altered to 13/11/2013
Updated on 12 December 2013
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to information about driving or using machinery
- Change to how the medicine works
- Change to date of revision
- Change to improve clarity and readability
Updated on 12 April 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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
· Additional data has been added to the final paragraph entitled ‘Cardiac and pulmonary disease’ regarding a significantly increased incidence of cardiac events with Vidaza.
4.8 Undesirable effects
· Three indications have been added to Table 1 under the column heading ‘Uncommon’, for the class ‘Skin and subcutaneous tissue disorders’
· Final paragraph added regarding cardiac events.
Updated on 09 April 2013
Reasons for updating
- Change to side-effects
Updated on 06 June 2012
Reasons for updating
- Change of manufacturer
Updated on 02 May 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 4.8 (undesirable effects) - Cellulitis has been added to the common side effects, see Table.
Section 5.3 (preclinical safety data) - Microphthalmia has been added to the list of foetal abnormalities.
Updated on 30 April 2012
Reasons for updating
- Change to side-effects
Updated on 16 February 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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Addition of laboratory tests regarding liver function tests and complete blood counts.
4.8 Undesirable effects
Addition of tomour lysis syndrome and injection site necrosis.
Updated on 24 January 2012
Reasons for updating
- Change to side-effects
Updated on 05 August 2011
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 5.2 - An additional line has been added to the excretion section regarding accumulation after subcutaneous administration of azacitidine
Updated on 27 July 2011
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 4.2 - Additional function test added to the Laboratory tests.
Additional sentence added to the Method of administration.
Section 4.3 - Replacement of a term (breastfeeding rather than lactation)
Section 4.4 - Additional warning to patients has been added and removal of the term 'rarely' regarding hepatic and renal impairments.
Section 4.6 - Sentences regarding contraception for women of child bearing potential and men moved from the end of the first paragraph to a separate initial paragraph.
Replacement of a term (breastfeeding rather than lactation)
Section 4.8 - Modifications to the third and fourth paragraphs regarding frequency of adverse events.
- Additional adverse event added to the table and alterations made to another adverse event already listed. Rare fatalities have been indicated where appropriate.
- Minor alterations to the infections sub-heading.
- Two paragraphs added regarding renal and hepatic adverse reactions.
Section 5.2 - Minor amendments to the excretion section.
Section 6.6 - Two additional sentences added to point 4 of the reconstitution procedure.
Section 7 - Address of the MA holder has been updated.
Updated on 26 July 2011
Reasons for updating
- New PIL for medicines.ie
Updated on 27 May 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 6.6 - Removal of the words "until use" in second paragraph under heading "For later use" so now reads "and kept in the refrigerator for a maximum of 22 hours".
Updated on 24 May 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 6.6 - Addition of paragraph under heading "Storage of reconsituted product" regarding extended fridge life of up to 22 hours when azacitidine is reconsituted with refrigerator temperature water.
Section 10 - Date of revision of text is now 5th May 2011.
Updated on 05 August 2010
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 5.2: In the second paragraph of the Metabolism section, the sentence beginning "In vitro studies" has been altered to "An in vitro study".
Also in the same paragraph, the sentence beginning "In a study to assess inhibition of a series of P450 isoenzymes" has been altered to state "In studies to assess..."
In this same sentence "CYP 2B6 and 2C8" have been added into the brackets after the word isoenzymes and the sentence that stated "The potential to inhibit CYP2B6 or 2C8 has not been studied" has been removed from the end of the metabolism section.
Updated on 30 April 2010
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 28 January 2009
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)