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Tarceva 25 mg, 100 mg & 150 mg Film-coated Tablets *
Pharmacy Only: Prescription

  • Company:

    Roche Registration GmbH

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Erlotinib Hydrochloride

    *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

$0$0$0$0$0$01.         NAME OF THE MEDICINALPRODUCT$0$0​$0$0Tarceva 25 mg film‑coatedtablets$0$0Tarceva100 mg film‑coated tablets$0$0Tarceva150 mg film‑coated tablets$0$0​$0$0​$0$02.       QUALITATIVE ANDQUANTITATIVE COMPOSITION$0$0​$0$0Tarceva25​mg film coated tablets$0$0One Each film‑coated tablet contains25 mg erlotinib (as erlotinib hydrochloride).$0$0​$0$0Tarceva100 mg film‑coated tablets$0$0Eachfilm‑coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride).$0$0​$0$0Tarceva150 mg film‑coated tablets$0$0Eachfilm‑coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride).$0$0​$0$0Excipients with knowneffect:$0$0​$0$0Tarceva25​mg film coated tablets$0$0Each 25 mg film-coated tablet contains 27.43​ mgLactose monohydrate.$0$0​$0$0Tarceva100 mg film‑coated tablets$0$0Each100 mg film-coated tablet contains 69.21​mg Lactose monohydrate.$0$0​$0$0Tarceva150 mg film‑coated tablets$0$0Each150 mg film-coated tablet contains 103.82​mg Lactose monohydrate.$0$0​$0$0For the full list ofexcipients, see section 6.1.$0$0​$0$0​$0$03.       PHARMACEUTICAL FORM$0$0​$0$0Film‑coated tablet.$0$0​$0$0Tarceva25​mg film coated tablets$0$0White to yellowish,round, biconvex tablets with ‘T 25’ engraved on one side.$0$0​$0$0Tarceva100 mg film‑coated tablets$0$0Whiteto yellowish, round, biconvex tablets with ‘T 100’ engraved on one side.$0$0​$0$0Tarceva150 mg film‑coated tablets$0$0Whiteto yellowish, round, biconvex tablets with ‘T 150’ engraved on one side.$0$0​$0$04.2     Posology and method of administration$0$0​$0$0Tarceva treatment shouldbe supervised by a physician experienced in the use of anti-cancer therapies.$0$0​$0$0Patients with Non-SmallCell Lung Cancer:$0$0EGFR mutation testingshould be performed prior to initiation of Tarceva asfirst-line or switch maintenance therapy intherapyin chemo-naïve patients with locally advanced or metastatic NSCLC.$0$0​$0$0[ ... ]$0$0​$0$0Patientswith hHepatic impairment:$0$0Erlotinib is eliminatedby hepatic metabolism and biliary excretion. Although erlotinib exposure wassimilar in patients with moderately impaired hepatic function (Child-Pugh score7-9) compared with patients with adequate hepatic function, caution should beused when administering Tarceva to patients with hepatic impairment. Dosereduction or interruption of Tarceva should be considered if severe adversereactions occur. The safety and efficacy of erlotinib has not been studied inpatients with severe hepatic dysfunction (AST/SGOT and ALT/SGPT> 5 x ULN).Use of Tarceva in patients with severe hepatic dysfunction is not recommended(see section 5.2).$0$0​$0$0Patientswith rRenal impairment:$0$0The safety and efficacyof erlotinib has not been studied in patients with renal impairment (serumcreatinine concentration >1.5 times the upper normal limit). Based onpharmacokinetic data no dose adjustments appear necessary in patients with mildor moderate renal impairment (see section 5.2). Use of Tarceva in patients with severe renal impairment is notrecommended.$0$0​$0$0[ .... ]$0$0​$0$04.4     Special warnings and precautions foruse$0$0​$0$0Assessment of EGFRmutation status$0$0When consideringthe use of Tarceva as a first line or maintenance treatment for locallyadvanced or metastatic NSCLC, it is important thatassessing the EGFR mutation status of a patient is determined.$0$0​$0$0, it is important that aA well-validated, and robust, reliableand sensitive test with aprespecified positivity threshold and demonstratedutility for the determination of EGFR mutation status, using either tumor DNAderived from a tissue sample or circulating free DNA (cfDNA) obtained from ablood (plasma) sample, should be performed according to local medical practice.methodologyis chosen to avoid$0$0​$0$0Ifa plasma-based cfDNA test is used and the result is negative for activatingmutations, perform a tissue test wherever possible due to the potentialfor false negative resultsfrom a plasma-based testorfalse positive determinations.$0$0[ ... ]$0$0​$0$04.8     Undesirable effects$0$0 $0$0[ ... ]$0$0Table 1:Very common ADRs in study BR.21$0$0​$0$0$0$0$0$0$0$0ErlotinibTarceva$0N=485$0$0$0$0Placebo$0N=242$0$0$0$0$0$0 $0$0[ ... ]$0$0 $0$0Table3:            Verycommon ADRs in study PA.3 (100​ mg cohort)$0$0​$0$0$0$0$0$0$0$0ErlotinibTarceva$0N = 259$0$0$0$0Placebo$0N = 256$0$0$0$0$0$0[ ... ]$0$0 $0$08.       MARKETING AUTHORISATIONNUMBER(S)$0$0​$0$0EU/1/05/311/001$0$0EU/1/05/311/002$0$0EU/1/05/311/003$0$0​$0$010.       DATE OF REVISION OF THETEXT$0$0​$0$022 February 2018$0$0​$0$0 $0$0 $0$0$0

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