Tarceva 25 mg, 100 mg & 150 mg Film-coated Tablets * Pharmacy Only: Prescription
Company:
Roche Registration GmbHStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 26 September 2022
File name
63316ef80c8e3.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/PSUSA/00001255/202111
Updated on 26 September 2022
File name
63316ecc3127c.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
EMEA/H/C/PSUSA/00001255/202111
Updated on 05 July 2021
File name
SmPC clean Tarceva_0July2021 _1625482757.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 March 2021
File name
SmPC tarceva clean FCT_1616770572.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 December 2018
File name
uk-ie-mt-pil-tarceva-clean-181115-25-100-150-tabs_1544716306.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 13 December 2018
File name
uk-ie-mt-spc-tarceva-clean-181115-25-100-150-tabs_1544716399.pdf
Reasons for 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
II58
Updated on 17 August 2018
File name
uk-ie-mt-pil-Tarceva-clean-180809-25-100-150-tabs_1534500081.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 21 May 2018
File name
uk-ie-mt-spc-Tarceva-clean-180406-25-100-150-tabs.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Transfer of MAH from Roche Products Limited to Roche Products GmbH
Updated on 23 April 2018
File name
uk-ie-mt-pil-Tarceva-clean-180406-25-100-150-tabs.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 28 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 March 2018
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- Change from individual to joint SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 December 2017
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
[….]
Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.
When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
[….]
10. DATE OF REVISION OF THE TEXT
11 December 2017
Updated on 01 February 2016
File name
PIL_10435_187.pdf
Reasons for updating
- New PIL for new product
Updated on 01 February 2016
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 24 January 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 26 July 2013
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 02 May 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to appearance of the medicine
Updated on 27 June 2012
Reasons for updating
- Change to side-effects
Updated on 01 September 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Changes to therapeutic indications
- Change to, or new use for medicine
Updated on 27 May 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 08 July 2010
Reasons for updating
- Change to warnings or special precautions for use
Updated on 05 May 2010
Reasons for updating
- Change to, or new use for medicine
Updated on 03 June 2009
Reasons for updating
- Change to side-effects
Updated on 13 February 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 05 February 2008
Reasons for updating
- Change to warnings or special precautions for use
Updated on 13 August 2007
Reasons for updating
- Change to warnings or special precautions for use
Updated on 26 March 2007
Reasons for updating
- Change to date of revision
Updated on 12 February 2007
Reasons for updating
- Change to how the medicine works
- Change to further information section
- Change to date of revision
Updated on 04 December 2006
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 28 March 2006
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 17 February 2006
Reasons for updating
- Change to marketing authorisation holder
Updated on 23 September 2005
Reasons for updating
- New PIL for new product