GEODON 20mg Capsules
*Company:
Upjohn EESVStatus:
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 16 May 2023
File name
Patient Information Leaflet - 002895787.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 19 January 2023
File name
Patient Information Leaflet - Geodon caps IE GE 184.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 19 January 2023
File name
SmPC - IE - Geodon 20mg caps - IE GE 184.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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)
Updated on 16 December 2022
File name
Patient Information Leaflet - Geodon caps IE GE 189.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 November 2021
File name
DEC202115256-V_Reg SPC GE 24_1 20mg Capsules IE - clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- 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
The SPC has been updated as follows:
Section 4.2 Posology and method of adminstration: Addition of method of adminstration
Section 4.6 Update to breast-feeding wording from 'taking' to 'receiving'
Section 4.8 Undersirable effects: updates to reporting of suspected adverse reactions (HPRA details)
Updated on 25 November 2021
File name
DEC202115256-V_Reg PIL GE 27_1 capsules IE_clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 25 November 2021
File name
DEC202115256-V_Reg SPC GE 24_1 20mg Capsules IE - clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- 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:
Section 4.2 Posology and method of adminstration: Addition of method of adminstration
Section 4.6 Update to breast-feeding wording from 'taking' to 'receiving'
Section 4.8 Undersirable effects: updates to reporting of suspected adverse reactions (HPRA details)
Updated on 27 July 2021
File name
DEC202110037-V_Reg SPC GE 23_0 20mg Capsules IE - clean.pdf
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 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address
Section 8 - updated with new PA number for Upjohn EESV
Updated on 27 July 2021
File name
DEC202110037-V_Reg PIL GE 26 capsules IE - clean.pdf
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 17 February 2021
File name
DEC202102600-V_Reg SPC GE 22_2 20mg Capsules IE-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- 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 17 February 2021
File name
DEC202102600-V_Reg PIL GE 24_3 capsules IE-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 19 December 2019
File name
DEC201971688_Reg SPC GE 21_1 20mg Capsules 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 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 December 2019
File name
DEC201971688_Reg PIL GE 23_1 capsules IE-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 20 November 2019
File name
DEC201964557_Reg SPC GE 20_0 20mg Capsules IE-clean.pdf
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
File name
Reg PIL GE 20_0 capsules IE_clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 10 August 2018
File name
Reg PIL GE 19_0 capsules IE _clean.pdf
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
File name
Reg SPC GE 18_1 20mg Capsules IE_clean_.pdf
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
File name
PIL_8722_689.pdf
Reasons for updating
- New PIL for new product
Updated on 11 July 2017
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 February 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 February 2017
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 23 February 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 25 January 2016
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 templateUpdated on 22 January 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to further information section
- Change to date of revision
- Change to dosage and administration
- Change to improve clarity and readability
Updated on 02 October 2014
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 20 March 2014
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
Updated on 17 March 2014
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 29 July 2013
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
Updated on 20 December 2012
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- 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 13 December 2012
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 06 June 2012
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of 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
Updated on 31 May 2012
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to how the medicine works
- Change to dosage and administration
Updated on 31 May 2012
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to how the medicine works
- Change to appearance of the medicine
Updated on 06 November 2009
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 - updated to include details referring to the new indication for the treatment of manic or mixed episodes of moderate severity in bipolar disorder in children and adolescents aged 10-17 years
Updated on 04 November 2009
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
- Changes to therapeutic indications
Updated on 03 March 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- 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
Sections 4.4 and 5.1 updated with outcomes of the ZODIAC study and section 4.8 updated with additional post-marketing adverse events
Updated on 03 March 2009
Reasons for updating
- Change to side-effects
Updated on 10 September 2008
Reasons for updating
- Change to name of manufacturer
Updated on 11 July 2007
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
Section 4.8 Update Section 4.8 (Undesirable effects)
Updated on 11 July 2007
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 21 August 2006
Reasons for updating
- 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 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- 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 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of 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
Updated on 21 August 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 13 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)