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A.Menarini Pharma U.K. S.R.L.
Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
Telephone: +44 (0) 1628 856400
Fax: +44 (0) 1628 856402
Medical Information Direct Line: 0800 085 8678
Medical Information e-mail: menarini@medinformation.co.uk
Out of Hours contact: menarini@medinformation.co.uk

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: 23/10/2008
SPC Migard

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 23/10/2008 and displayed until Current
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:   15-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to section 4.8 Undesirable effects

 

  • Adverse reactions table is updated due to migration to MedDRA system organ classification
  • Statement added regarding post-marketing reports of hypersensitivity reactions.

 

Update to section 10 Date of Revision of the text

 

  • Date of revision updated to July 2008
Updated on 11/03/2008 and displayed until 23/10/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • 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:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2 – Include excipient details for lactose

Section 4.4 - Update warning on prolonged use of painkillers for headaches, add reference to lactose.

Section 4.9 – Update information on overdose

Section 6.1 – Update details for the film coat (Macrogel 3000)

Sections 9 and 10 – Update date of renewal and revision of the text
Updated on 06/09/2005 and displayed until 11/03/2008
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 13/07/2005 and displayed until 06/09/2005
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 28/09/2004 and displayed until 13/07/2005
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 28/09/2004 and displayed until 28/09/2004
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Pending awaiting re-submission
Updated on 28/09/2004 and displayed until 28/09/2004
Reasons for adding or updating:
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 28/09/2004 and displayed until 28/09/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  frovatriptan