Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

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: 22/12/2011
SPC Modecate Injection 25mg/ml

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 22/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • 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:   06-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Bulk Type IB No. C.I.3.a variation to update the SPCs and leaflets to implement the final texts agreed by the Pharmacovigilance Working Party (PhVWP) regarding warnings for the use of antipsychotics during pregnancy and risk of abnormal muscle movements and/or withdrawal symptoms in newborns.
Updated on 01/12/2011 and displayed until 22/12/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   08-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
section 2 - composition clarified, including sesame oil content
Section 3 - colour added
section 4.3 - hypersensitivity contraindication reworded
section 4.6 - section title now includes "fertility"
Section 5.1 - Pharmacotherapeutic group details added
Section 6.1 - restructured
Section 6.4 - keep in outer carton added
Section 6.6 - no special requirements
Section 9 - dates corrected
Updated on 26/07/2011 and displayed until 01/12/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • 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:   08-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2

 

Revised wording and included statement re. sesame oil

 

Section 3

 

Replaced ‘Intramuscular injection for administration to human beings.’ With ‘Solution for Injection. Pale yellow clear, oily liquid.’

 

Sections 4.3, 4.6, 6.1, 6.4. 6.5, 6.6

 

Minor change to wording and/or formatting

 

Section 5.1

 

Added ‘Pharmacotherapeutic group: Psycholeptics; Phenothiazines with piperazine structure, ATC code: N05AB02’

 

Sections 9 & 10

 

New dates
Updated on 15/04/2010 and displayed until 26/07/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   10-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of risk of venous thromboembolism to sections 4.4 and 4.8
Updated on 08/05/2009 and displayed until 15/04/2010
Reasons for adding or updating:
  • 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:   19-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to the marketing authorisation number
Updated on 17/09/2007 and displayed until 08/05/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Use of sanofi aventis trading style
Updated on 19/09/2006 and displayed until 17/09/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
Updated on 12/05/2006 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change from BAN to rINN
Date of revision of text on the SPC:   22/04/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - Change BAN to rINN (amfetamine)
 
Section 4.8 - Change BAN to rINN (trihexyphendidyl and benzatropine)
Updated on 19/11/2004 and displayed until 12/05/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 03/10/2003 and displayed until 19/11/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 06/06/2003 and displayed until 03/10/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 26/09/2002 and displayed until 06/06/2003
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/08/2001 and displayed until 26/09/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  fluphenazine decanoate