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Roche Products Limited
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
Telephone: +44 (0)1707 366 000
Fax: +44 (0)1707 338 297
WWW: http://www.rocheuk.com
Medical Information Direct Line: +44 (0)800 032 7298
Medical Information e-mail: roche@professionalinformation.co.uk
Customer Care direct line: +44 (0)800 731 5711
Medical Information Fax: +44 (0)1748 828801

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: 11/05/2010
SPC Hypnovel 10mg/5ml solution for 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 11/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   26-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Underlined text has been added, text with strike through deleted:

 

1        NAME OF THE MEDICINAL PRODUCT

Hypnovel Ampoules 10mg/5ml solution for injection

 

 

 

 
Updated on 05/03/2008 and displayed until 11/05/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
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
Due to extensive changes to this SPC, please copy and paste the following url into your web browser to view the change details:
 
Updated on 14/02/2006 and displayed until 05/03/2008
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 7 - Marketing Authorisation Holder
Updated on 23/11/2005 and displayed until 14/02/2006
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 10/04/2003 and displayed until 23/11/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • 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 - Contra-indications
  • 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 4.6 - 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
Updated on 10/08/2001 and displayed until 10/04/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 17/04/2001 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/07/2000 and displayed until 17/04/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 06/07/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  midazolam hydrochloride