Palexia Oral Solution 20 mg/ml
Last Updated on eMC 15-Oct-2014 View document | Grunenthal Ltd Contact details
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 15-Oct-2014 and displayed until Current
Reasons for adding or updating:
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 4.8 - Undesirable effects - how to report a side effect
Date of revision of text on the SPC: 31-Jul-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2:'elderly patients' replaced by 'older people'
Section 4.8:
added rare post-marketing adverse reactions of 'andioedema, anaphylaxis and anaphylactic shock'
added words on reporting of adverse reactions to MHRA
Section 5.2:
'elderly' replaced by 'older'
Updated on 10-Apr-2014 and displayed until 15-Oct-2014
Reasons for adding or updating:
- New SPC for new product
Legal Category:POM
Black Triangle (CHM): NO
Grunenthal Ltd
Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK
+44 (0)870 351 8960
+44 (0)1494 486298
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