Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.com

Summary of Product Characteristics last updated on the eMC: 12/05/2011
SPC Nitro-Dur 0.2mg/h; 0.4mg/h and 0.6mg/h Transdermal Patch

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 12/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   20-Jan-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Update to Section 7 of the SPC (Marketing Authorisation Holder)
  • Marketing Authorisation Holder has been changed from Schering Plough Ltd, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, UK to Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Update to Section 8 of the SPC (Marketing Authorisation Number)

  • Nitro-Dur 0.2mg/h    PL 00025/0580
  • Nitro-Dur 0.4mg/h    PL 00025/0581
  • Nitro-Dur 0.6mg/h    PL 00025/0582

Update to Section 10 of the SPC (Date of Revision)
19 Jan 2011

Updated on 15/02/2005 and displayed until 12/05/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 08/08/2003 and displayed until 15/02/2005
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of Excipients
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/08/2001 and displayed until 08/08/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 26/07/2001 and displayed until 17/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 31/01/2001 and displayed until 26/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 30/03/2000 and displayed until 31/01/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 30/03/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   glyceryl trinitrate