Tecentriq 840 mg and 1,200 mg concentrate for solution for infusion
*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 22 October 2024
File name
TCN_PIL_IV_II88_19Sep2024.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Updated on 22 October 2024
File name
TCN_SmPC_IV_II88_19Sep2024.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 29 August 2024
File name
SmPC_Tecentriq 840 mg-1200 mg_II-0082_26Aug2024.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 24 June 2024
File name
TCN_IAin_IV_PIL_dated 20Jun2024.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 24 June 2024
File name
TCN_IAin_IV_SmPC_dated 20Jun2024.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 28 May 2024
File name
TEC_IV_II84_PIL_11Apr2024.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 May 2024
File name
TEC_IV_II84_SmPC_11Apr2024.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 22 March 2024
File name
TCN-SmPC-840_1200mg-220224.pdf
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 February 2024
File name
TCN-PIL-840-1200mg-22feb2024.pdf
Reasons for updating
- Change to improve clarity and readability
Updated on 29 February 2024
File name
TCN-SmPC-840-1200mg-22feb2024.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 February 2024
File name
TCN-840-1200mg PIL 22Feb24.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
Updated on 27 February 2024
File name
TCN-840-1200mg SmPC 22Feb24.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 17 January 2024
File name
IRL-TCN-840_1200mg_SmPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 October 2023
File name
Tecentriq_II0078_SmPC_31Aug2023.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Tecentriq Patient Card IE Version 26.1.3.pdf
Reasons for updating
- Add New Doc
Updated on 02 June 2023
File name
Tecentriq_II-0077_SmPC_26May2023.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 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 02 June 2023
File name
Tecentriq II-0077_PIL_26May2023.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 07 March 2023
File name
TecentriqII0075_PIL_27 Feb 2023.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 07 March 2023
File name
TecentriqII0075_Smpc_27 Feb 2023.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)
Updated on 20 February 2023
File name
TCN_PSUSA 2022_SmPC_Clean_09Feb2023.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)
Updated on 20 February 2023
File name
TCN_PSUSA 2022_PIL_Clean_Feb2023.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 29 July 2022
File name
TCN_SmPC_dated 25Jul2022.pdf
Reasons for updating
- 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)
Updated on 14 June 2022
File name
PIL_TCN_840mg-1200mg_II-0064_07Jun2022.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - possible side effects
Updated on 14 June 2022
File name
SmPC_TCN_840mg-1200mg_II-0064_07Jun2022.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 April 2022
File name
TCN_PIL_R0069_25 Apr 2022.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.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.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.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.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 20 January 2022
File name
SmPC_Tecentriq_840mg-1200mg_II-0067-02Dec2021_Clean.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.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.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.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.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.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.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.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.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)
File name
Tecentriq Patient Alert Card IE Version 17.1.0.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.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.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.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.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.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.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.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.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.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.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)
File name
Tecentriq Patient Alert Card IE Version 11.1.1 [PDF].pdf
Reasons for updating
- Add New Doc
Updated on 06 November 2020
File name
TCN_1200mg_II39_SmPC_clean.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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.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
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
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
Updated on 26 September 2017
Reasons for updating
- New PIL for new product