Summary of Product Characteristics
last updated on the eMC:
16/05/2012
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 16/05/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 20-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| Section 2
Updated to reflect new European-standard wording.
Section 4.3
Updated to reflect new European-standard wording.
Section 4.4
Updated to reflect class-effect warning concerning Keratitis.
Section 4.6
Updated to reflect new European-standard wording.
Section 4.8
Inclusion of keratitis, in line with change to section 4.4.
Section 6.4
Updated to reflect new European-standard wording.
Section 6.6
Updated to reflect new European-standard wording.
Section 9
Updated to reflect new European-standard wording.
Section 10
Approval Date amended to 20th April 2012.
|
|
Updated on 09/08/2011 and displayed until 16/05/2012
|
Reasons for adding or updating:
|
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 02-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 5.1
Addition of information relating to IPASS
|
|
Updated on 21/01/2011 and displayed until 09/08/2011
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 30-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.2
Updated information:
Paediatric population
The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established. There is no relevant use of IRESSA in the paediatric population in the indication of NSCLC.
Section 4.4
Changed text first paragraph under heading
‘Hepatotoxicity and liver impairment’
New additional text in last paragraph of section 4.4
Gastrointestinal perforation has been reported in patients taking IRESSA. In most cases this is associated with other known risk factors, including concomitant medications such as steroids or NSAIDs, underlying history of GI ulceration, age, smoking or bowel metastases at sites of perforation.
Section 4.6
Additional text at start of section: Women of childbearing potential
Women of childbearing potential must be advised not to get pregnant during therapy.
Section 4.8
Additional information in table 1:
Gastrointestinal disorders – Uncommon - gastrointestinal perforation
Hepatobiliary disorders – Uncommon – Hepatitis includes a footnote ***
Skin and subcutaneous tissue disorders – Very common - .....’ including skin fissures,’.....
Skin and subcutaneous tissue disorders - Rare - Cutaneous vasculitis
Renal and urinary disorders – Common – Cystitis
Renal and urinary disorders - Rare - Haemorrhagic cystitis
Additional footnote under Table 1
***This includes isolated reports of hepatic failure which in some cases led to fatal outcomes.
Section 4.9
Additional text in section.
Section 10
Change of revision date – 30 November 2010
|
|
Updated on 16/07/2009 and displayed until 21/01/2011
|
Reasons for adding or updating:
|
|
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
