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Repaglinide 0.5 mg Tablets

Last Updated on eMC 11-Jul-2016 View document  | Actavis UK 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 11-Jul-2016 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: 20-Jun-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Pharmacovigilance Risk Assessment Committee (PRAC) recommendations contained in the PSUR Assessment report resulting from the EU PSUSA (EMEA/H/C/PSUSA/00002618/201412) for repaglinide dated 10th September 2015.

 

SmPC sections updated 4.5 and 10

Updated on 14-Jan-2014 and displayed until 11-Jul-2016

Reasons for adding or updating:

  • Improved presentation of SPC

Date of revision of text on the SPC: 12-Apr-2013

Legal Category:POM

Black Triangle (CHM): NO

Updated on 02-Feb-2012 and displayed until 14-Jan-2014

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: 12-Jan-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.3 has been updated to register a shelf life extension from 2 years to 3 years.

Updated on 06-Jul-2011 and displayed until 02-Feb-2012

Reasons for adding or updating:

  • 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: 09-Jun-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Add pack size of 180 tablets blister pack for finished product/UK SPC 6.5/PIL

 

 

Updated on 23-Jun-2011 and displayed until 06-Jul-2011

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Company image
Address

Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Fax

+44 (0)1271 346 106

Medical Information e-mail
Telephone

+44 (0)1271 311 200

Medical Information Direct Line

+44 (0)1271 385 257

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?

Active ingredients

repaglinide

Legal categories

POM - Prescription Only Medicine

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