Summary of Product Characteristics
last updated on the eMC:
12/05/2011
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
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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Change to section 7 - Marketing Authorisation Holder
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| 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
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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
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Updated on 15/02/2005 and displayed until 12/05/2011
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 08/08/2003 and displayed until 15/02/2005
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 6.1 - List of Excipients
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 17/08/2001 and displayed until 08/08/2003
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Transferred from eMC version 1
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Updated on 26/07/2001 and displayed until 17/08/2001
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Updated on 31/01/2001 and displayed until 26/07/2001
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Updated on 30/03/2000 and displayed until 31/01/2001
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Updated on 06/09/1999 and displayed until 30/03/2000
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