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Cresemba 200mg powder for concentrate for solution for infusion.

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Pharmacy Only: Prescription

Updated on 30 August 2024

File name

Adv SPC CM 15_2 IE (clean).pdf

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 4.8 - 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 6.1 - List of excipients
  • 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 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Introduction of new pack/pack size

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 30 August 2024

File name

Adv SPC CM 15_2 IE (clean).pdf

Reasons for updating

  • Addition of joint SPC covering all presentations
  • 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 4.8 - 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 6.1 - List of excipients
  • 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 8 - Marketing authorisation number(s)
  • 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

·   Addition of information on Cresemba 40 mg capsules, to be used in paediatric patients 6 years and older

·   Extension of the indication to include treatment of paediatric patients aged 1 year and older for Cresemba 200 mg powder


Administrative updates

Updated on 30 August 2024

File name

Adv PIL CM 15_2 vial IE & NI (clean).pdf

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 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 23 May 2024

File name

clean Adv SPC CM 14_0 IE.pdf

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)

Updated on 22 December 2022

File name

AdvSPCCM131IEclean.pdf

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC NI and SPC IE have been updated as follows: 

• Section 4.5, Table 1 – typos (superscript of footnotes)

• Section 5.1 – update of pharmacotherapeutic group

• Section 6.1 (capsules only) – deletion of “purified water”

• Section 6.3 (capsules only) – addition of full stop


Updated on 22 December 2022

File name

AdvPILCM142vialIENIclean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 23 June 2022

File name

Adv PIL CM 13_1 vial IE NI 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 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 23 June 2022

File name

Adv SPC CM 12_1 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 04 November 2021

File name

Adv SPC CM 11_1 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 04 November 2021

File name

Adv PIL CM 12_2 vial IE & NI (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
  • Individual PILs superseded by joint PIL

Updated on 14 July 2021

File name

DEC202135279_Adv SPC CM 10_2 IE (clean).pdf

Reasons for updating

  • Removal of Black Inverted Triangle
  • Other

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Cresemba 200mg or ‘vials’ SPC was not updated at the same time as the Cresemba 100mg hard capsules SPC and both SPC were still displaying the inverted black triangle. This was removed from the SPC in August 2020.

Updated on 28 May 2021

File name

DEC202135279_Adv PIL CM 11_0 vial IE (clean).pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 25 February 2021

File name

DEC202112651_Adv SPC CM 9_0 IE (clean).pdf

Reasons for updating

  • 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 25 February 2021

File name

DEC202112651_Adv PIL CM 10_0 vial IE (clean).pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 28 August 2020

File name

DEC202053490_Adv SPC CM 8_0 IE Clean.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
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 August 2020

File name

DEC202053490_Adv SPC CM 8_0 IE Clean.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
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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)

Updated on 27 August 2020

File name

DEC202053490_Adv PIL CM 9_0 vial IE Clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 10 January 2020

File name

DEC202001397_Adv PIL CM 7_0 vial UK & IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 30 September 2019

File name

DEC201953839_Adv SPC CM 6_0 UK & IE Clean.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 30 September 2019

File name

DEC201953839_Adv PIL CM 6_0 vial UK & IE Clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 08 April 2019

File name

DEC201914643_Adv PIL CM 5_0 vial UK & IE CLEAN.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 14 March 2019

File name

Adv PIL CM 4_0 vial UK & IE clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 March 2019

File name

Adv SPC CM 5_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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

 Section 7 - MARKETING AUTHORISATION HOLDER

Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8

79539 Lörrach

Germany

Updated on 17 December 2018

File name

Adv PIL CM 3_0 Vial UK & IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change of distributor details

Updated on 17 December 2018

File name

Adv SPC CM 4_0 UK & IE clean.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.5: typos in Table 1

Updated on 26 November 2018

File name

Adv PIL CM 2_0 Capsules UK & IE clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 26 November 2018

File name

Adv SPC CM 3_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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

 

4.4  Special warnings and precautions for use

Subheading; Elevated liver transaminases or hepatitis updated to include reports of hepatitis.

 

4.8 Side-effects

Hepatitis added as Uncommon side effect

Updated on 31 August 2018

File name

Adv SPC CM 2_0 UK & IE clean.pdf

Reasons for updating

  • 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

The SPC has been updated as follows:

6.3  Shelf life

 

Update to shelf life from 24 months to 48 months for vial presentation only

Updated on 28 August 2018

File name

Adv_SPC_CM_1_0_UK_&_IE_clean.pdf

Reasons for updating

  • Change to improve clarity and readability

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The MAH, Basilea do not have an account with medicines.ie, however they have agreed for Pfizer to update the website under Pfizer banner and Pfizer med info contact details. Basilea will be added as the MA Holder of Cresemba.

Updated on 18 May 2018

File name

Adv PIL CM 1_0 Vial UK & IE clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 May 2018

File name

Adv_SPC_CM_1_0_UK_&_IE_clean.docx

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

Update Revision Date