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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: 03/01/2012
SPC Nozinan injection

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 03/01/2012 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
To update section 4.6 and 4.8 of the SPC and leaflet with information on the use of conventional and atypical antipsychotics during pregnancy and the risk of abnormal muscle movements and withdrawal symptoms in newborns.
Updated on 27/04/2010 and displayed until 03/01/2012
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:   22-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - addition of warning re risk of increaed mortality in elderly patients with dementia

Section 4.4 - addition of risk of VTE
Updated on 23/12/2009 and displayed until 27/04/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   17-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following changes have been made to the SPC:

Section 2: Change of wording- Levomepromazine INN (methotrimeprazine BAN) hydrochloride 25mg per ml to: Levomepromazine hydrochloride 25mg per ml. And addition of following text: For excipients, see 6.1.

 

Section 3: addition of following text: Clear, colourless solution contained in a clear glass ampoule.

 

Section 5.1: addition of following text: ATC Code: NO5AA02 Pharmacotherapeutic group: Antipsychotics

 

Section 6.1: change to formatting, and change to spelling of sulphite to sulfite.
Updated on 16/09/2008 and displayed until 23/12/2009
Reasons for adding or updating:
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   01-Nov-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of MA holder to Archimedes Pharma
Updated on 04/08/2005 and displayed until 16/09/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 24/03/2004 and displayed until 04/08/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 17/12/2003 and displayed until 24/03/2004
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 20/08/2001 and displayed until 17/12/2003
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  levomepromazine hydrochloride