Summary of Product Characteristics
last updated on the eMC:
14/05/2009
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 14/05/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 31-Dec-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
4.5 Interaction with other medicinal products and other forms of interaction
This section has changed. Interactions with anti-arrhythmics, anti-depressants and antimuscarinics which apply only to the ‘sublingual’ route of administration have been removed.
Sildenafil (Viagra): sildenafil has known effects on the nitric oxide/cGMP pathway, and has been shown to potentiate the hypotensive effects of nitrates such as Glyceryl TrinitrateSterile Concentrate.
7. MARKETING AUTHORISATION HOLDER.
Name change
Hopsira UK Limited
Queensway
Royal Leamington Spa
Warwickshire, CV31 3RW
10. DATE OF REVISION OF THE TEXT
Date of revision changed
31st December 2007
|
|
Updated on 24/02/2003 and displayed until 14/05/2009
|
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 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 - Instruction for Use/Handling
|
|
Updated on 16/07/2002 and displayed until 24/02/2003
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 02/07/2002 and displayed until 16/07/2002
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 12/06/2002 and displayed until 02/07/2002
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
Updated on 03/07/2001 and displayed until 12/06/2002
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 03/07/2001
|
Reasons for adding or updating:
|
|
|
|