Epanutin Infatabs - Summary of Product Characteristics (SPC) - History

Home | About the eMC | Help | Mobile

eMC - trusted, up to date and comprehensive information about medicines

Search medicine/company name only

Search full document

Advanced search

Medicine name A-Z | Active ingredient A-Z | Pharmaceutical company A-Z | Latest medicine updates | Yellow card report

Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ Telephone: +44 (0)1304 616 161 Fax: +44 (0)1304 656 221 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?

Summary of Product Characteristics last updated on the eMC: 09/03/2012

SPC	Epanutin Infatabs

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 09/03/2012 and displayed until Current

Reasons for adding or updating:
Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC: 29-Feb-2012
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.8 of the SPC has been updated.

Updated on 19/07/2010 and displayed until 09/03/2012

Reasons for adding or updating:
Change to section 4.3 - Contraindications 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 4.7 - Effects on Ability to Drive and Use Machines Change to section 4.8 - Undesirable Effects Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC: 01-Jul-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
SmPC: Sections 4.3 (Contra-Indications), 4.4 (Special Warnings), 4.5 (Interactions) & 5.2 (Pharmacokinetic Properties), 4.7 (Ability to drive and use machines) and 4.8 (Undesirable Effects).

Updated on 01/06/2010 and displayed until 19/07/2010

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: 25-May-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
SmPC: Section 4.4 (Special Warnings): *Wording update for phenytoin-related Stevens Johnson Syndrome (SJS) and association with HLA-B1502.** :

Updated on 01/12/2008 and displayed until 01/06/2010

Reasons for adding or updating:
Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC: 18-Nov-2008
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 4.4 - Addition of class warning for anti-epileptics regarding suicidal ideation and behaviour.