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Sanofi Pasteur MSD Limited
Mallards Reach, Bridge Avenue, Maidenhead, Berkshire, SL6 1QP
Telephone: +44 (0)1628 785 291
Fax: +44 (0)1628 671 722
Medical Information Direct Line: +44 (0)1628 587 693
Medical Information e-mail: medinfo@spmsd.com
Medical Information Fax: +44 (0)1628 635 072

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: 22/12/2010
SPC Stamaril

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 22/12/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4 update of transmission
4.8 update on lacation-not to be given in nursing mothers
Updated on 13/05/2010 and displayed until 22/12/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Plunger stopper: Replacement of chlorobromobutyl by halobutyl

Tip cap: Addition of .styrene - butadiene.
Updated on 07/04/2008 and displayed until 13/05/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 1 – description of pharmaceutical form updated in line with SPC guidelines, ‘Powder and solvent for suspension for injection in pre-filled syringe’

Change to section 6.6 – minor changes to the wording of the instructions for use to improve clarity.

Change to section 10 – date of review changed to 03/09/2007
Updated on 13/08/2007 and displayed until 07/04/2008
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 11/12/2006 and displayed until 13/08/2007
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 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic 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. 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 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 1, 2, 3, 4, 5, 6 - Harmonisation of wording across Europe and alignment with QRD template.

 

Section 4.2 - Inserted details on:

▪ administration to adults and children aged > 9 months, infants aged 6-9 months and the elderly

▪ re-vaccination

▪ method of administration.

 

Section 4.3 - Updated and re-worded contraindications.

 

Section 4.4 - Updated/added information on:

▪ Association of vaccine with neurotropic and viscerotropic disease

▪ Administration to immunosuppressed and HIV infected persons, children born to HIV positive mothers, children aged 6-9 months and persons aged>60 years

▪ Administration via intramuscular injection

▪ Patients with hereditary problems of fructose intolerance should not take this vaccine.

 

Section 4.6 - Added information on pregnancy and lactation

 

Section 4.8 - Re-organised text

Added effects include: nausea, diarrhoea, vomiting, neurotropic disease and viscerotropic disease.

 

Section 10 - Change date of revision of text to July 2006
Updated on 14/11/2005 and displayed until 11/12/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 27/09/2005 and displayed until 14/11/2005
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 25/09/2003 and displayed until 27/09/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/09/2002 and displayed until 25/09/2003
Reasons for adding or updating:
  • New SPC for new product
Updated on 07/08/2002 and displayed until 17/09/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  yellow fever vaccine