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Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension

  • Name:

    Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension

  • Company:
    info
  • Active Ingredients:

    Losartan potassium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/04/18

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Summary of Product Characteristics last updated on medicines.ie: 25/6/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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Medicine Name Cozaar 12.5mg, 50mg & 100mg Film-coated Tablets Active Ingredients Losartan potassium
Medicine Name Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension Active Ingredients Losartan potassium
Medicine Name Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets Active Ingredients Hydrochlorothiazide, Losartan potassium
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1 - 0 of 84 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 25 June 2019 SmPC

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
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Safety label update

 

Updated on 26 April 2018 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 6.4 (update on the information about the storage conditions); Correction of spelling/typing errors

Updated on 20 April 2018 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 6.4 (update on the information about the storage conditions)

Updated on 16 April 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 7 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 September 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to name of medicinal product
  • Correction of spelling/typing errors

Updated on 10 June 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 30 April 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions

Updated on 30 April 2015 SmPC

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to Section 4.1 - Therapeutic indications

Addition of references

 

Change to Section 4.2 - Posology and method of administration

Addition of references

 

Change to Section 4.3 – Contraindications

Addition of information on the contraindication of concomitant use with aliskiren containing products

 

Change to Section 4.4 - Special warnings and precautions for use

Addition of information on Dual Blockade

 

Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction

Addition of information on Dual Blockade

 

Change to Section 5.1 - Pharmacodynamic properties

Addition of Clinical Trail data regarding Dual Blockade

Updated on 30 April 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 February 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration

Updated on 5 February 2014 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 - Interactions with other medicinal products and other forms of interaction, Change to Section 4.8 - Undesirable effects, Change to Section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • 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 - Interactions with other medicinal products and other forms of interaction, Change to Section 4.8 - Undesirable effects, Change to Section 5.1 - Pharmacodynamic properties

Updated on 4 November 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to marketing authorisation holder

Updated on 31 January 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to Section 4.8 - Undesirable effects

Updated on 17 August 2012 PIL

Reasons for updating

  • Change to date of revision

Updated on 2 July 2012 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 6 June 2012 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to Section 5.1 - The changes add data following the results from the extension phase of Paediatric Protocol 326: Efficacy and safety study in proteinuria with or without hypertension in children 1-17 years

Updated on 10 June 2011 PIL

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to dosage and administration

Updated on 14 February 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update section 4.1, 4.2, 4.8 & 5.1 of SPC following the HEAAL Study.

Updated on 17 May 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 18 November 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

To include compliance statement in Section 10. at end of the SPC.

Updated on 23 October 2009 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 October 2009 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided