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Bayer Limited

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: 03/10/2011
SPC Adalat Retard 20 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 03/10/2011 and displayed until Current
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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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:   26-Aug-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Following approval of Company Core Data Sheet ( CCDS) version #22, the following SPC sections have been updated.

Section 2.0, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.1 and section 10.0.
Updated on 19/12/2008 and displayed until 03/10/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 09/12/2008 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
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Changes to Scetion 4.3, 4.4 and 4.6.
Updated on 17/11/2008 and displayed until 09/12/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 14/11/2008 and displayed until 17/11/2008
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)

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Active Ingredients

 
   Nifedipine

Versions

 
03/10/2011 to Current
19/12/2008 to 03/10/2011
09/12/2008 to 19/12/2008
17/11/2008 to 09/12/2008
14/11/2008 to 17/11/2008
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  • Contact Us

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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