Summary of Product Characteristics
last updated on the eMC:
03/05/2012
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 03/05/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
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: 13-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section
|
Summary of change
|
|
7.
|
Change of name of MAH
|
|
10.
|
Updated with new date of revision of text
|
|
|
Updated on 14/11/2011 and displayed until 03/05/2012
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 24-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Summary of Change
4.2 Addition of warning on taking requip XL wth a high fat meal. Information on dosing in patients with end stage renal disease.
5.2 Additional information on Pharmacokinetic effects on taking Requip XL with food. Additional information on pharmacokinetics of Requip XL in patients with end stage renal disease.
10 Updated with new date of revision of text
|
|
Updated on 26/04/2011 and displayed until 14/11/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
| Date of revision of text on the SPC: 05-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section Changes:
6.5 Minor text changes
|
|
Updated on 11/04/2011 and displayed until 26/04/2011
|
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 4.3 - Contraindications
-
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 4.6 - 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 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 5.3 - Preclinical Safety Data
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 05-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Summary of changes:
Sections:
4.1 Harmonise with EU SPC- extensive amendments
4.2 Harmonise with EU SPC- extensive amendments
4.3 Harmonise with EU SPC- extensive amendments
4.4 Harmonise with EU SPC- extensive amendments
4.5 Harmonise with EU SPC- extensive amendments
4.6 Harmonise with EU SPC- extensive amendments
4.7 Harmonise with EU SPC- extensive amendments
4.8 Harmonise with EU SPC- extensive amendments
5.1 Harmonise with EU SPC- extensive amendments
5.2 Harmonise with EU SPC- extensive amendments
5.3 Harmonise with EU SPC- extensive amendments
10 Updated with new revision date
|
|
Updated on 31/03/2011 and displayed until 11/04/2011
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 23-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Updated Sections:
Section 1- Removal of black triangle
Section 10- New date of revision
|
|
Updated on 09/02/2011 and displayed until 31/03/2011
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 31-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.2 Updated with amended text regarding the use in children and adolescents
Section 10 Revision of text 31/01/2011
|
|
Updated on 15/07/2009 and displayed until 09/02/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 05-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
|
Section 6.3 - Shelf life
ReQuip XL 2mg prolonged-release tablets 2 years.
ReQuip XL 4mg prolonged-release tablets 3 years.
ReQuip XL 8mg prolonged-release tablets 3 years.
Section 10 - DATE OF REVISION OF THE TEXT
05/06/2009
|
|
Updated on 11/06/2009 and displayed until 15/07/2009
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
|
Section 6.3 - Shelf life
2 years.
Section 10 - DATE OF REVISION OF THE TEXT
01/06/2009
|
|
Updated on 17/11/2008 and displayed until 11/06/2009
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 11-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.2 - Addition of information regarding dyskinesias
Section 4.8 - Addition of hypersensitivity and information regarding dyskinesias
|
|
Updated on 08/05/2008 and displayed until 17/11/2008
|
Reasons for adding or updating:
|
|
|
|
