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Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 08/05/2012
SPC Xanax Tablets 250, 500 micrograms; Xanax Tablets 1 mg

When a pharmaceutical company changes an SPC or PIL, 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 08/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-Apr-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
SPC: PL number, revision date and MA holder name have been updated to reflect Change of ownership
Updated on 17/10/2011 and displayed until 08/05/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

SmPC change of the name of MA holder from Pharmacia Ireland Limited to Pharmacia Ireland
Updated on 19/11/2010 and displayed until 17/10/2011
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Mar-2008
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Section 6.3 shelf life (changed from 5 years to 3 years)
Updated on 26/02/2008 and displayed until 19/11/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 

2.2 – addition of word “Excipients”under qualitative and quantitative composition

3.0 – addition of scoreline statement under each strength of the tablet

6.4 – deletion of bottle pack

6.5 - deletion of glass bottle and metal screw cap   

 
Updated on 11/09/2006 and displayed until 26/02/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   04/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 4.2 - Posology and Method of Administration, Change to section 4.3 - Contra-indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.6 - Pregnancy and Lactation, Change to section 4.7 - Effects on Ability to Drive and Use Machines, Change to section 4.8 - Undesirable Effects, Change to section 4.9 - Overdose, Change to section 6. 6 - Instruction for Use/Handling
Updated on 01/09/2006 and displayed until 11/09/2006
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   04/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
  • Section 2 – to include the quantity of lactose monohydrate
  • Section 4.2 – a caution has been added
  • Section 4.3 – hypersensitivity updated to include any component of the formulation
  • Section 4.4 – additional symptoms of dependence added, the duration of treatment  updated to include discontinuation of the product and specific patient  groups  updated.
  • Section 4.5 – interactions updated based on data currently available.
  • Section 4.6 – updated to include Xanax
  • Section 4.7 – updated to include the effects of alcohol.
  • Section 4.8 – undesirable effects updated.
  • Section 4.9 – overdosage updated.
  • Section 6.6 – Sub heading updated to include precautions of use and disposal.
Updated on 02/08/2006 and displayed until 01/09/2006
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   04/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 
 
Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 4.2 - Posology and Method of Administration, Change to section 4.3 - Contra-indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.6 - Pregnancy and Lactation, Change to section 4.7 - Effects on Ability to Drive and Use Machines, Change to section 4.8 - Undesirable Effects, Change to section 4.9 - Overdose, Change to section 6. 6 - Instruction for Use/Handling
Updated on 07/04/2006 and displayed until 02/08/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 26/05/2005 and displayed until 07/04/2006
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
Updated on 06/08/2004 and displayed until 26/05/2005
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 07/07/2003 and displayed until 06/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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