Zavicefta 2g/0.5g powder for concentrate for solution for infusion

  • Name:

    Zavicefta 2g/0.5g powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Ceftazidime Pentahydrate, Avibactam sodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/04/19

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Summary of Product Characteristics last updated on medicines.ie: 12/4/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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226 - 231 of 231 items.Total: 10 pages

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 15 April 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 April 2019 SmPC

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)

Updated on 31 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 31 October 2018 SmPC

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

The SPC has been updated as follows:

Section 10: DATE OF REVISION OF THE TEXT has been updated – (10/2018)

Updated on 25 July 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Improved presentation of PIL

Updated on 25 July 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Sections 4.2 (Posology and method of administration) and 4.8 (Undesirable effects) updated following completion of the paediatric study C3591004.

Section 4.4 sodium statement updated to align with the Annex to the EU Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’.

Updated on 6 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 February 2018 SmPC

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 - MA Holder address "Operations Services Group" corrected to "Operations Support Group".

Updated on 5 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 February 2018 PIL

Reasons for updating

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

Updated on 8 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 January 2018 SmPC

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

None provided