Adalat retard 20 mg modified-release tablets
Last Updated on eMC 30-Sep-2016 View document | Bayer plc Contact details
Versions
- 30-Sep-2016 to Current
- 23-Aug-2016 to 30-Sep-2016
- 20-Aug-2015 to 23-Aug-2016
- 03-Feb-2014 to 20-Aug-2015
- 21-Dec-2012 to 03-Feb-2014
- 16-Apr-2012 to 21-Dec-2012
- 07-Mar-2012 to 16-Apr-2012
- 15-Feb-2012 to 07-Mar-2012
- 23-Jul-2010 to 15-Feb-2012
- 01-Jul-2010 to 23-Jul-2010
- 17-Sep-2009 to 01-Jul-2010
- 03-Jun-2008 to 17-Sep-2009
- 29-Jun-2005 to 03-Jun-2008
- 19-Dec-2003 to 29-Jun-2005
- 04-Sep-2003 to 19-Dec-2003
- 03-Sep-2003 to 04-Sep-2003
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 30-Sep-2016 and displayed until Current
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Fertility, pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 19-Sep-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:To implement nifedipine CCDS changes and therefore update information related to patients with hepatic impairment in the SmPC; add changes resulting from a new pharmacokinetic study.
Updated on 23-Aug-2016 and displayed until 30-Sep-2016
Reasons for adding or updating:
- Change to section 4.6 - Fertility, pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 10-Aug-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
Implementation of Adalat PSUSA EMA/394060/2016 outcome, inclusion of information on tocolytic use in pregnant women, SmPC sections 4.6 and 4.8 updated and PIL section 4.
Updated on 20-Aug-2015 and displayed until 23-Aug-2016
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 4.6 - Fertility, pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 05-Aug-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
· To update sections 2., 4.2, 4.3, 4.4, 4.6, 4.8, 5.1 and 6.3 of the SmPC in line with QRD template.
Updated on 03-Feb-2014 and displayed until 20-Aug-2015
Reasons for adding or 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 4.6 - Fertility, pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 22-Jan-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Changes to sections 4.2 (Posology and method of administration), 4.3 (Contraindications), 4.4 (Special warnings and precautions for use), 4.6 (Pregnancy and Lactation) and 4.8 (Undesirable effects), in line with the agreed CSP resulting from the Nifedipine PSUR Workshare.
Updated on 21-Dec-2012 and displayed until 03-Feb-2014
Reasons for adding or updating:
- Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC: 12-Apr-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Delete the "Bayer Schering Pharma" Logo.Updated on 16-Apr-2012 and displayed until 21-Dec-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: 12-Apr-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes to the SmPCs are:
· The statement 'Trading as Bayer plc, Bayer Schering Pharma' has been removed from Section 7 of the SmPC.
Updated on 07-Mar-2012 and displayed until 16-Apr-2012
Reasons for adding or updating:
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 16-Jan-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:- Update to section 10 " Date of revision of the text".
Updated on 15-Feb-2012 and displayed until 07-Mar-2012
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable Effects
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 24-Nov-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:- to update sections 4.2 (Posology and method of administration) and 5.1 (Pharmacodynamic properties) of the SmPC in line the overall conclusion and recommendation from an Art 45 EU worksharing procedure; with consequential changes to the PIL.
- a separate update to section 4.8 (Undesirable effects) in line with the CCDS; with consequential changes to the PIL.
Updated on 23-Jul-2010 and displayed until 15-Feb-2012
Reasons for adding or updating:
- Change to section 6. 3 - Shelf Life
- Change to section 6. 5 - Nature and Contents of Container
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 02-Jul-2010
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
- change to section 6.3 to remove the information on the shelf-life of product packaged in PVC blister strips;
-
change to section 6.5 to remove the description of the PVC blister strip.
Updated on 01-Jul-2010 and displayed until 23-Jul-2010
Reasons for adding or updating:
- Change to section 1 -Name of the Medicinal product
- 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: 04-Jun-2010
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 1 ( Product Name) : This has been amended to add the strength and pharmaceutical form to the product name, in line with the current SPC guideline.Section 6.1 ( List of excipients): this section has been updated to bring the names of excipients in line the European Pharmacopoeia
Section 10 (Revision date) this is now 4 June 2010
Updated on 17-Sep-2009 and displayed until 01-Jul-2010
Reasons for adding or updating:
- Change to section 6. 3 - Shelf Life
- Change to section 10 date of revision of the text
Date of revision of text on the SPC: 09-Sep-2009
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 6.3 - shelf life has been extended from 30 months to 48 months.Section 10 - Revision date is now 09.09.2009
Updated on 03-Jun-2008 and displayed until 17-Sep-2009
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 5.3 - Preclinical Safety Data
- Change to section 10 date of revision of the text
- Change to section 4.4 - Special warnings and precautions for Use
- Change to section 4.6 - Pregnancy and Lactation
- Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC: 22-May-2008
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 have been updated following global labelling harmonisation in line with the Company Core Data Sheet.Updated on 29-Jun-2005 and displayed until 03-Jun-2008
Reasons for adding or updating:
- Individual SPC superseded by joint SPC covering several presentations
- Change to section 6. 5 - Nature and Contents of Container
- Change to section 10 (date of (partial) revision of the text
Updated on 19-Dec-2003 and displayed until 29-Jun-2005
Reasons for adding or updating:
- Change to section 4.2 - Posology and Method of Administration
- Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
- Change to section 4.8 - Undesirable Effects
Updated on 04-Sep-2003 and displayed until 19-Dec-2003
Reasons for adding or updating:
- Improved Electronic Presentation
Updated on 03-Sep-2003 and displayed until 04-Sep-2003
Reasons for adding or updating:
- New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
+44 (0)1635 563 393
+44 (0)1635 563 000
Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
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