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Bayer Limited
The Atrium, Blackthorn Road, Dublin 18,
Telephone: +353 1 2999 313
Fax: +353 1 2061 456
Summary of Product Characteristics last updated on medicines.ie: 12/01/2012
SPC Adalat LA 60

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 12/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   05-Jan-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


New printing ink containing Iron oxide black (E172), Shellac & Propylene Glycol (E1520)
Updated on 12/09/2011 and displayed until 12/01/2012
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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Apr-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Update to SPC sections following IMB approval of Company Core Data Sheet (CCDS) version 16.
Updated on 22/06/2009 and displayed until 12/09/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   27-May-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


  • In section 6.1 ( List of Excipients), Structure updated to include; Osmotic Blend, Organic Coating and Light Protective Coating, Macrogol 4000 is removed and replaced with Macrogol 3350, Iron Oxide, red (E172) is removed and replaced with Ferric oxide, red ( E172).
  • In section 10 (Date of revision of the text); November 2008 is removed and replaced with May 2009.
Updated on 19/12/2008 and displayed until 22/06/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Inclusion of "Excipients: Sodium"
Updated on 04/12/2008 and displayed until 19/12/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes made to section 4.3, 4.4 and 4.6.
Updated on 26/08/2008 and displayed until 04/12/2008
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   05/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 5.3 Preclinical safety data
The sentence: "All of the doses associated with the teratogenic, embryotoxic effects in animals were maternally toxic and several times the recommended maximum dose for humans" was changed to:
"All of the doses associated with the teratogenic, embryotoxic or fetotoxic effects in animals were maternally toxic and several times the recommended maximum dose for humans"
Updated on 26/08/2008 and displayed until 26/08/2008
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Nifedipine