Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Last Updated on eMC 31-May-2017 View document | GlaxoSmithKline UK 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 31-May-2017 and displayed until Current
Reasons for adding or updating:
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 18-May-2017
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
SPC Section 4.5. Interaction with other medicinal products and other forms of interactionUpdate to align to PRAC recommendation on drug interaction with corticosteroids
Updated on 04-May-2017 and displayed until 31-May-2017
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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 21-Apr-2017
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Section 4.2 - Additional information regarding desiccant sachet
The SUMMIT submission:
-Addition of safety data to Section 4.4 and Section 4.8
-Addition of study design, mortality and CV composite endpoint data to Section 5.1.
-In addition, ‘bronchospasm’ was added to Section 4.8 List of Adverse Reactions, and there is a minor correction to the pharmacodynamics section of Section 5.1.
Updated on 16-Nov-2016 and displayed until 04-May-2017
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 13-Oct-2016
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Section 4.4 Special warnings and precautions for usePneumonia in patients with COPD
Rewording text in line with Article 31 referral
Updated on 23-Dec-2015 and displayed until 16-Nov-2016
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
- Correction of spelling/typing errors
Date of revision of text on the SPC: 17-Dec-2015
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Update to SPC
Update section 4.8 of the SPC in order to add muscle spasms as a new adverse reaction with the frequency Common.
Minor typographical amendment to COPD paediatric population text in section 4.2 of the SPC.
Updated on 30-Sep-2015 and displayed until 23-Dec-2015
Reasons for adding or updating:
- 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-Sep-2015
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Update section 4.8 of the SPC in order to add anxiety and tremor as new adverse reactions with the frequency rare
Updated on 02-Jul-2015 and displayed until 30-Sep-2015
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for use
- 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: 25-Jun-2015
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Update section 4.4 - in order to amend warning regarding Cardiovascular effects
Update section 4.8 - addition of Palpitations and Tachycardia as new adverse reactions with the frequency rare
Updated on 07-Jan-2015 and displayed until 02-Jul-2015
Reasons for adding or updating:
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 18-Dec-2014
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
Section 4.8 – Addition of hypersensitivity adverse event
Section 5.1 – Typo updates
Updated on 08-Jan-2014 and displayed until 07-Jan-2015
Reasons for adding or updating:
- New SPC for new product
Legal Category:POM
Black Triangle (CHM): YES
GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
+44 (0)208 990 4328
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