Summary of Product Characteristics
last updated on the eMC:
17/10/2011
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 17/10/2011 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: 21-Dec-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 1 addition of the name NiQuitin Pre-Quit Clear 21mg Patch
|
|
Updated on 21/10/2010 and displayed until 17/10/2011
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.6 - Pregnancy and Lactation
|
| Date of revision of text on the SPC: 11-Oct-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.1 changed to include further indications:-
-as an aid to smokers wishing to quit or reduce prior to quitting
-to assist smokers who are unwilling or unable to smoke
-as a safer alternative to smoking for smokers and those around them
-in pregnant and lactating women making a quit attempt
Section 4.2
Directions for use added for gradual cessation, reduction in smoking and temporary abstinence
Restrictions for 9 months use in adults removed, and smokers advised to contact a HCP if they are having difficulty discontinuing patch use.
Resctrictions for 12 weeks use in children removed and adolescents advised to contact a HCP if they are not ready or not able to quit abruptly.
Section 4.6 pregnancy and lactation reworded.
|
|
Updated on 27/08/2009 and displayed until 21/10/2010
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 06-Aug-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Update to section 4.8 to include anaphylactic reactions and photosensitivity
|
|
Updated on 21/09/2007 and displayed until 27/08/2009
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 03/2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 1 - 'CQ' removed from trade name
Section 4.4 - 'Safety on handling' section added
Section 10 - revision date updated to March 2007
|
|
Updated on 09/12/2005 and displayed until 21/09/2007
|
Reasons for adding or updating:
|
-
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 10 (date of (partial) revision of the text
|
|
Updated on 24/12/2003 and displayed until 09/12/2005
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
