Cubicin 350mg Powder for Solution for injection or infusion
*Company:
MSD Ireland (Human Health) LimitedStatus:
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 11 July 2024
File name
QRD-IE-MT-UKNI-CUBICIN350MG-LFT-N-088-CRT-20062024.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to further information section
Free text change information supplied by the pharmaceutical company
Section 6: update to email address for Ireland in the List of Local Representatives. Editorial updates also made to section 6.
Updated on 30 January 2023
File name
CUBICIN-H-C-0637-IAIN-078-SPC-IE-en-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC document format updated to html
Updated on 21 September 2022
File name
QRD-IE-MT-UKNI-CUBICIN350MG-LFT-BRX-NIP clean FT 16-May-2022.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
Free text change information supplied by the pharmaceutical company
Addition of United Kingdom (Northern Ireland) details to section 4 and section 6 of the PIL.
Updated on 14 October 2021
File name
CUBICIN-H-C-0637-IAIN-078-SPC-IE-en-CRT.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).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.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.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.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).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).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
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
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 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
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
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
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