Geodon 40 mg capsules

  • Name:

    Geodon 40 mg capsules

  • Company:
    info
  • Active Ingredients:

    ziprasidone hydrochloride monohydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/11/18

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Summary of Product Characteristics last updated on medicines.ie: 20/11/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 227 items.Total: Infinity 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 20 November 2019 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

The following changes to the labelling have been approved. Please refer to attached copy/copies of labelling documentation for full details.

The SPC has been updated as follows: Section 6.5 – details of bottle presentation deleted

Updated on 26 November 2018 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 August 2018 PIL

Reasons for updating

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

Updated on 10 August 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 11 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 February 2017 SmPC

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

The SPC has been updated as follows:

s4.8  CDS update to add adverse drug reaction frequencies.

Updated on 24 February 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 24 February 2017 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

s4.8  CDS update to add adverse drug reaction frequencies.

Updated on 26 January 2016 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

1) Section 4.4 updated for all formulations to include a warning relating to the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and other Severe Cutaneous Adverse Reactions (SCAR) with ziprasidone.

2) Section 4.8 updated to add Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) as an adverse drug reaction and include an update in line with the latest QRD template

Updated on 26 January 2016 SmPC

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:

1) Section 4.4 updated for all formulations to include a warning relating to the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and other Severe Cutaneous Adverse Reactions (SCAR) with ziprasidone.

2) Section 4.8 updated to add Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) as an adverse drug reaction and include an update in line with the latest QRD template

Updated on 20 March 2014 SmPC

Reasons for updating

  • 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

Update to sections 5.2 & 10

Updated on 20 March 2014 PIL

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Update to sections 5.2 & 10

Updated on 29 July 2013 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

To update section 4.8 that describe the adverse effects of Geodon in paediatric patients aged 10-17 years and 13-17 years, from Phase 3 placebo –controlled studies in bipolar mania and schizophrenia, respectively

Updated on 29 July 2013 SmPC

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

To update section 4.8 that describe the adverse effects of Geodon in paediatric patients aged 10-17 years and 13-17 years, from Phase 3 placebo –controlled studies in bipolar mania and schizophrenia, respectively

Updated on 20 December 2012 SmPC

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 20 December 2012 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

None provided