Vidaza

  • Name:

    Vidaza

  • Company:
    info
  • Active Ingredients:

    azacitidine

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/04/19

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Summary of Product Characteristics last updated on medicines.ie: 24/11/2020

Click on this link to Download PDF directly

Celgene Ltd

Celgene Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Abraxane Active Ingredients Paclitaxel Albumin
Medicine Name Imnovid Active Ingredients Pomalidomide
Medicine Name Revlimid 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules Active Ingredients Lenalidomide
Medicine Name Thalidomide Active Ingredients Thalidomide
Medicine Name Vidaza Active Ingredients azacitidine
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 24 November 2020

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

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 15 April 2019

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Updated on 20 March 2019 PIL

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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 14 August 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Reasons for updating

  • File format updated to PDF

Updated on 1 June 2018

Reasons for updating

  • New SmPC 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 PIL

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 SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 18 July 2016 SPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 July 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 11 April 2016 SPC

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

Update to section 4.4, 4.8 and 10.

Updated on 7 April 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 17 November 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects

Updated on 11 November 2015 SPC

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 PIL

Reasons for updating

  • Change to side-effects
  • Changes to therapeutic indications

Updated on 6 March 2015 SPC

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 3 March 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 17 November 2014 SPC

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 7 November 2014 PIL

Reasons for updating

  • Change due to harmonisation of PIL
  • Correction of spelling/typing errors

Updated on 11 August 2014 SPC

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

HPRA details added

Updated on 23 July 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 31 January 2014 SPC

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 1 - mL instead of ml
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 PIL

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 SPC

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 9 April 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 6 June 2012 PIL

Reasons for updating

  • Change of manufacturer

Updated on 2 May 2012 SPC

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 4.2 (posology and method of administration) - Mathematical symbols substituted for text in the section titled dose adjustment due to haematological toxicity.  In the paragraph concerning Patients without reduced baseline blood counts: greater than or equal to signs are used instead of greater than only.  Symbols have replace text in the section Patients with reduced baseline blood counts.

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 16 February 2012 SPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 5 August 2011 SPC

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 SPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 May 2011 SPC

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 4.2 - removal of the the words "or equal to" in seventh paragraph, so now reads "less than 50 %, or greater than 50 %"

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 SPC

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 4.2 - Dose adjustment due to haematological toxicity, now reads: "Following Vidaza treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is less than or equal to 50 %, or greater than 50 %"


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 5 August 2010 SPC

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 SPC

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

Additon of hyphens to RAEB-T (previously RAEB T)

Updated on 28 January 2009 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to restricted prescription (C)