Tecentriq 840 mg and 1,200 mg concentrate for solution for infusion *
Pharmacy Only: Prescription

  • Company:

    Roche Registration GmbH
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 29 April 2022

File name

TCN_PIL_R0069_25 Apr 2022_1651224661.pdf

Reasons for updating

  • Removal of Black Inverted Triangle
  • Change to date of revision

Updated on 29 April 2022

File name

TCN_SmPC_R0069_25 Apr 2022_1651224543.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle
  • Updated inline with QRD template and/or excipient guideline

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

Updated on 04 March 2022

File name

TCN-PIL-PSUSA-23Feb2022-Clean_1646385073.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 March 2022

File name

TCN-SmPC-PSUSA-23Feb2022-Clean_1646384943.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 10 - Date of revision of the text

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

Updated on 02 February 2022

File name

PIL_Tecentriq_840mg-1200mg_II-0067_02Dec2021_Clean_1643816121.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 20 January 2022

File name

SmPC_Tecentriq_840mg-1200mg_II-0067-02Dec2021_Clean_1642669623.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 20 January 2022

File name

PIL_Tecentriq_840mg-1200mg_II-0067_02Dec2021_Clean_1642669475.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 September 2021

File name

PIL_Tecentriq_840mg-1200mg_IAIN_20Sept2021_Clean_1632304709.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 22 September 2021

File name

SmPC_Tecentriq_840mg-1200mg_IAIN_20Sept2021_Clean_1632304630.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 27 August 2021

File name

Tecentriq_SmPC_840mg-1200mg_Clean_1630066264.pdf

Reasons for updating

  • Addition of joint SPC covering all presentations
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

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

Updated on 27 August 2021

File name

Tecentriq_PIL_840mg-1200mg_Clean_1630066202.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Addition of joint PIL covering all presentations

Updated on 19 August 2021

File name

SmPC_Tecentriq_1200mg_art 613_12Aug2021_Clean_1629361651.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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

Updated on 19 August 2021

File name

PIL_Tecentriq_1200mg_art613_12Aug2021_Clean_1629361555.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to date of revision

Updated on 23 June 2021

File name

TCN_SmPC_1200mg_II-0058_clean_1624447684.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

EDM Updated on 15 June 2021

File name

Tecentriq Patient Alert Card IE Version 17.1.0_1623791413.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Tecentriq Patient Alert Card (IE Version 17.1.0) has been updated in line with EU RMP V17.1 to remove reference to the HCP Brochure as this material has been withdrawn.

Updated on 11 May 2021

File name

TCN_SmPC_1200mg_II-33_30Apr2021_Clean_1620752611.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 11 May 2021

File name

TCN_PIL_1200mg_II-33_30Apr2021_clean_1620752372.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 April 2021

File name

TCN_1200mg_SmPC_II-30_Mar2021_Clean_1619623480.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 13 April 2021

File name

TCN_SmPC_1200mg_II-0054_clean_1618313041.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 13 April 2021

File name

TCN_PIL_1200mg_II-0054_clean_1618312958.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 07 April 2021

File name

TCN_1200mg_SmPC_PSUSA_26 Mar 2021_clean_1617821615.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 07 April 2021

File name

TCN_1200mg_PIL_PSUSA_26 Mar 2021_clean_1617821549.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 03 March 2021

File name

TCN_1200mg_SmPC_IB-0056_clean_1614770352.pdf

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Updated on 09 February 2021

File name

TCN_1200mg_SmPC_II-0048_Clean_1612892479.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Updated on 13 January 2021

File name

TCN_1200mg_SmPC_II-0050_clean_1610551671.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

EDM Updated on 25 November 2020

File name

Tecentriq Patient Alert Card IE Version 11.1.1 [PDF]_1606306373.pdf

Reasons for updating

  • Add New Doc

Updated on 06 November 2020

File name

TCN_1200mg_II39_SmPC_clean_1604676558.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 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

variation II-0039 HCC

Updated on 06 November 2020

File name

TCN_1200mg_II39_PIL_clean_1604676300.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

variation II-0039 HCC

Updated on 19 October 2020

File name

TCN_1200mg_SmPC_03Sep2020_clean_1603108749.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 19 October 2020

File name

TCN_1200mg_PIL_03Sep2020_clean_1603108617.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 August 2020

File name

TCN_1200mg_SmPC_19Aug2020_clean_1598539265.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 27 August 2020

File name

TCN_1200mg_PIL_19Aug2020_clean_1598539187.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 28 May 2020

File name

TCN_1200mg_II40_SmPC_clean_1590677653.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 28 May 2020

File name

TCN_1200mg_II40_PIL_clean_1590677567.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 May 2020

File name

Tecentriq 1200mg SmPC_IA_13May2020_clean_1589994057.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Updated on 20 May 2020

File name

Tecentriq 1200mg SmPC_IA_13May2020_clean_1589993668.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 27 March 2020

File name

ie-mt-spc-tecentriq-clean-200213-1200mg-inf_1585309461.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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)

Updated on 27 March 2020

File name

ie-mt-pil-tecentriq-clean-200213-1200mg-inf_1585309243.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 04 March 2020

File name

TCN_SmPC_1200mg_Feb2020_clean_1583321609.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 4.8 - Undesirable effects

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

Updated on 04 March 2020

File name

TCN_PIL_1200mg_Feb2020_clean_1583321559.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects

Updated on 24 February 2020

File name

SmPC_Tecentriq_Vial_ 1200mg-20ml_IB_Feb-2020-clean_final_1582568324.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Updated on 24 February 2020

File name

PIL_Tecentriq_Vial_ 1200mg-20ml_IB_Feb-2020-clean_final_1582568244.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to date of revision

Updated on 12 September 2019

File name

TCN_1200_SmPC_03Sep2019_clean_1568296139.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties

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

Updated on 12 September 2019

File name

TCN_1200_PIL_03Sep2019_clean_1568295964.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects

Updated on 04 September 2019

File name

TCN_1200_SmPC_26Aug2019_clean_1567613440.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 04 September 2019

File name

TCN_1200_PIL_26Aug2019_clean_1567613055.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 29 August 2019

File name

Tecentriq PIL dated July 2019_Approval 21 Aug 2019_V3_clean_1567014369.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 28 August 2019

File name

Tecentriq SmPC dated 11 July 2019_Approval 21 Aug 2019_V3_clean_1567014281.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 19 July 2019

File name

Tecentriq PIL dated Jul 2019_II-0024_clean_1563471614.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 July 2019

File name

Tecentriq SmPC dated 08 Jul 2019_II-0024_clean_1563471927.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 28 June 2019

File name

Tecentriq PIL dated May 2019_Clean_1561650933.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 27 June 2019

File name

Tecentriq SmPC dated 02 May 2019_clean_1561651124.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

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

Updated on 06 June 2019

File name

Tecentriq PIL dated May 2019_1559752428.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 05 June 2019

File name

Tecentriq SmPC dated 25 may 2019_clean_1559752548.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

In-use extension 24 h at 2-8°C to 30 d at 2-8°C

Updated on 15 March 2019

File name

uk-ie-mt-pil-tecentriq-clean-190305-1200mg-inf_1552584567.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - possible side effects
  • Change to MA holder contact details
  • Change to date of revision

Updated on 14 March 2019

File name

uk-ie-mt-spc-tecentriq-clean-190305-1200mg-inf_1552585788.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Extension of the use of Tecentriq in combination with bevacizumab, paclitaxel and carboplatin for the first-line treatment of adult patients with NSCLC. Update the pooled monotherapy safety population for Tecentriq.

Updated on 12 March 2019

File name

uk-ie-mt-pil-tecentriq-clean-190225-1200mg-inf_1552405148.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 March 2019

File name

uk-ie-mt-spc-tecentriq-clean-190225-1200mg-inf_1552405285.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 4.8 - Undesirable effects
  • 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

Update of section 4.2, 4.4 and 4.8 of the SmPC to add immune-related nephritis as a rare adverse drug reaction and to include relevant posology recommendations, a warning and a description of the ADR, respectively. 

Updated on 16 August 2018

File name

uk-ie-mt-pil-tecentriq-clean-180809-1200mg-inf_1534416332.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 02 August 2018

File name

uk-ie-mt-spc-tecentriq-clean-180702-1200mg-inf_1533221546.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 30 July 2018

File name

uk-ie-mt-pil-tecentriq-clean-180702-1200mg-inf_1532941732.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 10 July 2018

File name

uk-ie-mt-spc-Tecentriq-clean-180702-1200mg-inf.docx

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic 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

Restriction of the currently authorised indication in cisplatin-ineligible urothelial carcinoma patients to exclude patients whose tumors have a PD-L1 expression 

Updated on 10 July 2018

File name

uk-ie-mt-pil-Tecentriq-clean-180702-1200mg-inf.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision

Updated on 11 May 2018

File name

uk-ie-mt-spc-Tecentriq-clean-180404-1200mg-inf.doc.docx

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 4.8 - Undesirable effects
  • 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

Addition of  myocarditis an immune related adverse reaction to the product information

Updated on 16 April 2018

File name

uk-ie-mt-pil-Tecentriq-clean-180404-1200mg-inf.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 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 14 March 2018

File name

PIL_17311_694.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 March 2018

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

$0 $0$07.       MARKETING AUTHORISATION HOLDER$0$0 $0$0Roche Registration GmbH $0$0Emil-Barell-Strasse 1$0$079639 Grenzach-Wyhlen$0$0Germany$0$0Roche Registration Limited$0$06 Falcon Way$0$0Shire Park$0$0Welwyn Garden City$0$0AL7 1TW$0$0United Kingdom$0$0 $0$010.     DATE OF REVISION OF THE TEXT$0$0 $0$007March 2018$0$0 $0

Updated on 14 March 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 16 November 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

Underlined text has been added, text with strike-through deleted:

6.3     Shelf life

 

Unopened vial

32 years.

 

Diluted solution

Chemical and physical in‑use stability has been demonstrated for no more than 24 hours at 2 °C to 8 °C or 248 hours at ambient temperature (≤ 30 °C) from the time of preparation.

 

From a microbiological point of view, the prepared solution for infusion should be used immediately. If not used immediately, in‑use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at  2 °C to 8 °C or 8 hours at ambient temperature (≤ 25 °C).

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 21 September 2017

 

10.     DATE OF REVISION OF THE TEXT

 

10 November 2017

Updated on 15 November 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 27 September 2017

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 26 September 2017

Reasons for updating

  • New PIL for new product