Cubicin 350mg Powder for Solution for injection or infusion *

  • Company:

    MSD Ireland (Human Health) Limited
  • Status:

    Updated
  • Legal 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

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 14 October 2021

File name

CUBICIN-H-C-0637-IAIN-078-SPC-IE-en-CRT_1634214862.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 5.2 - Pharmacokinetic 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

  • Information added to section 5.2 regarding the impact of race on pharmacokinetics.
  • Linguistic corrections undertaken in sections 4.2 and 4.4.
  • Date of revision updated in section 10.

 

Updated on 12 March 2021

File name

CUBICIN-H-C-0637-IAIN-076-G-350mg-PIL-IE-en-CRT (002)_1615544874.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 September 2020

File name

CUBICIN-H-C-0637-II-075-SPC-IE-en-CRT (002).pdf_1600332836.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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Updated inline with QRD template and/or excipient guideline

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

Free text change information supplied by the pharmaceutical company

  • Section 4.4: Sections added regarding “Severe cutaneous adverse reactions”, “Tubulointerstitial nephritis” and “Sodium”
  • Section 4.8:
    • Addition of the adverse reaction “Tubulointerstitial nephritis (TIN)” to the System Organ Class Renal and urinary disorders under frequency Not known in Table 1 in section 4.8
    • Removal of “drug rash with eosinophilia and systemic symptoms (DRESS)” & “vesicobullous rash with mucous membrane involvement” from the System organ class Immune system disorders in Table 1 in section 4.8 and addition of “drug reaction with eosinophilia and systemic symptoms (DRESS)” and “vesiculobullous rash with or without mucous membrane involvement (SJS or TEN)” to the System Organ Class Skin and subcutaneous tissue disorders in Table 1 in section 4.8.
    • Update to HPRA details in section 4.8 / Reporting of suspected adverse reactions.
  • Section 4.2: Addition of the following text: “For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.”
  • Clostridium difficile-associated diarrhoea” changed to “Clostridioides difficile-associated diarrhoea” in sections 4.4 and 4.8.
  • Editorial updates and updates in line with QRD template.

Updated on 17 September 2020

File name

CUBICIN-H-C-0637-II-075-350mg-PIL-IE-en-CRT (002).pdf_1600332431.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • 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 18 January 2019

File name

CUBICIN-H-C-0637-IA-071-SPC-IE-en-CRT_1547827149.pdf

Reasons for updating

  • 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

Editorial update to correct date of latest renewal in section 9 of the SPC

 

Updated on 30 August 2018

File name

CUBICIN-H-C-0637-T-069-350mg-PIL-IE-en-CRT (2)_1535624121.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
  • Change to other sources of information section

Updated on 30 August 2018

File name

CUBICIN-H-C-0637-T-069-SPC-IE-en-CRT (2)_1535624445.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)

Free text change information supplied by the pharmaceutical company

Update to Marketing Authorisation Holder name and address in section 7 of the SPC

Updated on 16 July 2018

File name

CUBICIN_H_C_0637_PSUSA_017_SPC_IE_en_CRT (2).docx

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Update to section 4.8 of the SPC to add the adverse reaction: Thrombocytopaenia

Updated on 16 July 2018

File name

CUBICIN_H_C_0637_PSUSA_017_350mg_PIL_IE_en_CRT (2).pdf

Reasons for updating

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

Updated on 12 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 12 March 2018

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Update to section 4.8 of the SPC to add the adverse events: leukocytosis, muscle cramps and eye irritation. Editorial updates to section 5.1 of the SPC

Updated on 08 March 2018

File name

PIL_10853_632.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 March 2018

Reasons for updating

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

Updated on 11 December 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.5 - 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 10 - Date of revision of the text
  • Change from individual to joint SPC

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 to extend the Staphylococcus aureus bacteraemia indication to include paediatric patients 1 to 17 years of age.  

In addition, the SPCs for the 350mg and 500mg strength have been combined together into one document and the SPC has been updated in line with the latest QRD template version 10.

Updated on 07 December 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Correction of spelling/typing errors

Updated on 06 December 2017

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency
  • 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 6 - date of revision
  • Change to information for healthcare professionals
  • Correction of spelling/typing errors

Updated on 16 August 2017

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 5.2 - Pharmacokinetic 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

Addition of text regarding organising pneumonia to sections 4.4 and 4.8.

A number of editorial amendments were made to sections 5.1 and 5.2.

Updated on 18 July 2016

Reasons for updating

  • Change of manufacturer

Updated on 08 July 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 06 July 2016

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Updates to Section 4.8 -Undesirable effects and Section 10 – Date of revision of the the text following the approval of PSUR (PSUSA 931-201509)

Updated on 09 June 2016

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)

Free text change information supplied by the pharmaceutical company

The changes are:

Transfer of Marketing Authorisation from

 

Novartis Europharm Limited                       to:                          Merck Sharp & Dohme Ltd

Frimley Business Park                                                                    Hertford Road, Hoddesdon        

Camberley GU16 7SR                                                                     Hertfordshire EN11 9BU

United Kingdom                                                                               United Kingdom

Updated on 09 June 2016

Reasons for updating

  • Change of manufacturer
  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 20 January 2016

Reasons for updating

  • Change to dosage and administration

Updated on 01 December 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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

Updated to extend the cSSSI indication of Cubicin to paediatric patients (1 to 17 years of age).

Updated on 23 July 2015

Reasons for updating

  • Change to dosage and administration
  • Change to MA holder contact details

Updated on 25 June 2015

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data
  • 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

·         Update Sections 4.4 and 5.3 of the EU SmPC with additional preclinical information from a neonatal dog study

·         Update Section 6.6 to include more detail to describe the technique to reconstitute lyophilised Cubicin

·         Update Section 7 to reflect the change in the address of the MAH from “Novartis Europharm Limited, Horsham, UK” to “Novartis Europharm Limited, Frimley Business Park, UK”

Updated on 11 June 2014

Reasons for updating

  • Change to appearance of the medicine
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 27 May 2014

Reasons for updating

  • 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

Correct date of revision from May 2014 to April 2014

Updated on 21 May 2014

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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

·         Removal of cautionary statement about use in elderly patients from SPC Section 4.2

·         Update the drug product appearance from “lyophilised powder” to “lyophilised cake or powder” to in SPC Section 3

·         Addition of the reporting requirements for adverse events to SPC Section 4.8

Updated on 04 July 2013

Reasons for updating

  • Change to name of manufacturer

Updated on 17 September 2012

Reasons for updating

  • Change to side-effects
  • Change to improve clarity and readability

Updated on 29 February 2012

Reasons for updating

  • 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

Following new adverse reactions in Section 4.8 (frequency “not known” as based on post marketing reports):

·         Angioedema

·         Drug rash with eosinophilia and systemic symptoms (DRESS)

·         Cough

Updated on 23 March 2011

Reasons for updating

  • Change to side-effects

Updated on 02 March 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)

Free text change information supplied by the pharmaceutical company

Inclusion of warning on eosinophilic pneumonia

Updated on 05 October 2009

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 09 December 2008

Reasons for updating

  • Correction of spelling/typing errors
  • Change to date of revision

Updated on 17 April 2007

Reasons for updating

  • Change to marketing authorisation holder

Updated on 04 May 2006

Reasons for updating

  • New PIL for new product