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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: 13/10/2011
SPC Phenergan 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 13/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   05-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • Section 2 – First sentence amended to “Each ampoule contains 25mg/ml of the active substance Promethazine hydrochloride”. Also added “Also contains 0.5mg of sodium sulphite anhydrous (E221) and 0.7mg of sodium metabisulphite (E223)”
  • Section 4.1 – Last two sentences removed as they were included in this section in erro
  • Section 4.4 – Sentence added; “Phenergan contains Sodium Sulphite and may rarely cause severe hypersensitivity reactions and bronchospasm”
  • Section 4.6 – Title of section amended to ‘Fertility, pregnancy and lactation’
  • Section 5.1 – Addition of ATC and pharmacotherapeutic group to include the 4th level
  • Section 6.5 – Removal of non-marketed pack size
  • Section 9 – Date of first authorisation and last renewal added        
Updated on 28/04/2010 and displayed until 13/10/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   08-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of product name from Phenergan solution for injection 25% w/v to Phenergan 25mg/ml solution for injection
Updated on 18/08/2009 and displayed until 28/04/2010
Reasons for adding or updating:
  • 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:   09-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9: 9 February 2009
Section 10: 9 February 2009
Updated on 07/04/2009 and displayed until 18/08/2009
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   19-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change in MA number to reflect change in owndership
Updated on 06/03/2008 and displayed until 07/04/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to sections 4.2, 4.3, 4.4 and 4.8  to include a variation to contraindicate use in children under 2 years of age because of the potential for fatal respiratory depression.
 
Updated on 18/09/2007 and displayed until 06/03/2008
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
Section 7 (Marketing Authorisation Holder): Change in MA Holder's details
Updated on 31/08/2005 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 16/08/2004 and displayed until 31/08/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 29/11/2002 and displayed until 16/08/2004
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/08/2002 and displayed until 29/11/2002
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Updated on 23/08/2001 and displayed until 13/08/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 13/10/2000 and displayed until 23/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 04/10/2000 and displayed until 13/10/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 04/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  promethazine hydrochloride