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MSD Ireland (Human Health) Limited
Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 04/04/2012
SPC Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets

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 04/04/2012 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:   30-Mar-2012
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 7 - The Marketing Authorisation Holder has been transferred.
Section 8 - The Marketing Authorisation Numbers have been changed.
Updated on 10/02/2012 and displayed until 04/04/2012
Reasons for adding or updating:
  • 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 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   22-Dec-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



4.5 - data on Dual blockade (e.g. by adding an ACE-inhibitor to an angiotensin II receptor antagonist)

4.6 - additional information on Cozaar-Comp and breast-feeding

6.4 - update to storage conditions for HDPE

6.5 - description of HDPE bottle 
Updated on 25/10/2011 and displayed until 10/02/2012
Reasons for adding or updating:
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   28-Sep-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Update to Sections: 4.5, 4.8, 5.2 & 6.4.
Updated on 16/11/2010 and displayed until 25/10/2011
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Oct-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Renewal - Changes to Section 9 and 10 (Date of revision/approval of text on SPC)
Updated on 15/04/2010 and displayed until 16/11/2010
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to joint SPC covering all presentations
Date of revision of text on the SPC:   15-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
 Change to joint SPC covering all presentations
Sections have changed: 4.6, 5.1, 6.4 & 6.5
Change to Pregnancy and lactation, ATC code, storage conditions and pack size

 

 

 

 
Updated on 09/06/2009 and displayed until 15/04/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   19-May-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


To include information relative to losartan and updates following recommendations from the Pharmacovigilance Working Party. Also change in excipient.
Updated on 21/05/2008 and displayed until 09/06/2009
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Hydrochlorothiazide
  Losartan potassium