Last Updated on eMC 12-01-2018 View medicine  | 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.

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:29-12-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Topiramate Accord Healthcare 25mg, 50mg, 100mg, 200mg Film-coated Tablets – PL 20075/0718, 0719, 0716, 0717 - UK National

 

Approval date – 25mg - 20/12/2017 (Approval received date 05/01/2018)

                                50mg - 29/12/2017 (Approval received date 05/01/2018)

                                100mg - 02/01/2018

                                200mg - 02/01/2018

 

Expiry date –     25mg - 20/06/2018 (renewal submitted 29/08/2012)

                                50mg - 28/06/2018 (renewal submitted 29/08/2012)

                                100mg - 01/07/2018 (renewal submitted 29/08/2012)

                                200mg - 01/07/2018 (renewal submitted 29/08/2012)

 

From – Actavis Group PTC ehf, Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland, Topiramate Accord Healthcare 25mg, 50mg, 100mg, 200mg Film-coated Tablets, PL 30306/0185, 0186, 0187, 0188

 

To – Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom, Topiramate Accord Healthcare 25mg, 50mg, 100mg, 200mg Film-coated Tablets – PL 20075/0718, 0719, 0716, 0717

 

 

Variation approval #2– 12/12/2017

 

Single Variation

Variation type: IB A.2.b

 

Variation Description: To register a change in the name of the finished product from Topiramate Actavis Film-Coated Tablets to Topiramate Accord Healthcare Film-coated Tablets.

 

SmPC sections updated– 1, 3, 4.4, 6.5  and 10

PIL section updated (title and introduction sections affected)

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 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:06-10-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Topiramate Actavis 25mg, 50mg, 100mg, 200mg Film-Coated Tablets, PL 30306/0185-8

 

Variation approval date: 06.10.2017

 

Single Variation

Variation Type: IB C.I.z

 

Variation Description: To update section 2, 4.2, 4.3, 4.6, 4.8, 9 of the SmPC and PIL and Labelling for Topiramate Actavis 25mg, 50mg, 100mg, 200mg Film-Coated Tablets, in line with the latest QRD-template (version 10, 02/2016).

 

SmPC sections updated: 2, 4.2, 4.3, 4.6, 4.8, 9 and 10.

PIL sections updated: PIL introduction, 2, 3, 4, 5 and 6.

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:14-10-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.5 of the SPC has been updated to to register a new type of tablet container - Polyethylene container closed with a threaded neck and twist-off cap with integrated dessicant.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:15-07-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to SPC sections 4.8 and 10.

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product

Date of revision of text on the SPC:14-02-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To change the invented name of the medicinal product in the UK from

’Topiramate 25/50/100/200mg Film-Coated Tablets’

to ’Topiramate Actavis 25/50/100/200mg Film-Coated Tablets’.

As a consequence, section 1 (name) of the SPC has been updated.

The PIL and label have been updated accordingly.

 

 

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, 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 10 - Date of revision of the text

Date of revision of text on the SPC:24-04-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

CCSI version 6 reference - EU PSUR worksharing procedure finalised for topiramate on 04/12/12 - final assessment report issued and core safety profile (CSP)

Reasons for adding or updating:

  • Change to section 4.6 - Pregnancy and Lactation

Date of revision of text on the SPC:10-07-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



To update section 4.6 (pregnancy and fertility) of the SPC in line with a PhVWP concerning Topiramate and the risk of congenital malformations

 

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:25-10-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To change the storage conditions to “Do not store above 25 deg C” and to extend the shelf life from 24 months to 3 years

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 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:26-04-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Sections 4.4, 4.8, 5.1 & 10 updated following the publication of a paediatric assessment report for a European work-sharing procedure for Topiramate.

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO