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Dysport 500U

Last Updated on eMC 24-Jul-2017 View document  | Ipsen 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 24-Jul-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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: 11-Jul-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Addition of new indication: Axillary Hyperhidrosis

Updated on 13-Mar-2017 and displayed until 24-Jul-2017

Reasons for adding or updating:

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Date of revision of text on the SPC: 27-Feb-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Clinical and non-clinical updates for Paediatric indication; and QRD updates

Updated on 16-Jan-2017 and displayed until 13-Mar-2017

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 09-Jan-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to ADR section 4.8

Updated on 12-Dec-2016 and displayed until 16-Jan-2017

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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: 06-Dec-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 and 2: update to name in line with QRD template
Section 4.1 and 4.2: Inclusion of indication for adult lower limb in spasticity
Section 4.8: Inclusion of AEs related to adult lower limb
Section 5.1: Inclusion of summary of clinical data provided in order to register adult lower limb indication

Updated on 28-Jun-2016 and displayed until 12-Dec-2016

Reasons for adding or updating:

  • New individual SPC (was previously included in joint SPC)

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8: addition of nausea as a side effect for spasmodic torticollis indication.
Rewording of some side-effects under the general, Dynamic equinus foot deformity due to focal spasticity, spasmodic torticollis and Blepharospasm and hemifacial spasm indications sections.

 

Company contact details

Ipsen Ltd

Company image
Address

190 Bath Road, Slough, Berkshire, SL1 3XE

Fax

+44 (0)1753 627 778

Medical Information e-mail
Telephone

+44 (0)1753 627 777

Medical Information Direct Line

+44 (0)1753 627 777

Customer Care direct line

+44 (0)1753 627 627

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

clostridium botulinum type a toxin-haemagglutinin complex

Legal categories

POM - Prescription Only Medicine

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