Ofev 100 mg soft capsules *

  • Company:

    Boehringer Ingelheim Limited
  • Status:

    Updated
  • Legal 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 01 September 2021

File name

Ofev 100 mg PIL - PSUSA-00010319-202010_1630489527.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 01 September 2021

File name

O3-EU-SPC-20 medicines.ie_1630489312.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)

Free text change information supplied by the pharmaceutical company

  • Section 4.4: Addition of warning on thrombotic microangiopathy
  • Section 10: The date of revision of the SmPC has been updated to 18 August 2021 to align with the date of the Commission Decision/approval.

Updated on 30 June 2021

File name

Ofev 100 mg PIL II-0040 06 May 2021_1625060170.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 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 28 June 2021

File name

O3-EU-SPC-19 medicines.ie_1624877153.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 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)

Free text change information supplied by the pharmaceutical company

Section 4.4: inclusion of a new warning for nephrotic range proteinuria

Section 4.8: inclusion of proteinuria as a new adverse reaction; update of the frequency for renal failure for the indication ‘Other chronic fibrosing ILDs with a progressive phenotype’ from Uncommon to Not known; AE reporting details rearranged.

Section 5.1: correction of percentage figures under the sub-section ‘Time to progression (≥ 10% absolute decline of FVC % predicted) or death’.

Section 10:  the date of revision of the SmPC has been updated to 06 May 2021

Updated on 04 June 2021

File name

Ofev 100 mg PIL for WS2027 April 21_1622806499.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 03 June 2021

File name

O3-EU-SPC-18 - For medicines.ie_1622733329.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

  • Section 4.2 Posology and method of administration: under ‘Method of administration’ the additional statement ‘The capsule should not be opened or crushed (see section 6.6).’ has been included. Note: ‘or crushed’ was included previously but has been moved to the new statement.
  • Section 6.6 Special precautions for disposal: this section has now been renamed ‘Special precautions for disposal and other handling’ and the following statement included – ‘In the event of coming in contact with the content of the capsule, hands should be washed off immediately with plenty of water (see section 4.2).’
  • Section 10 Date of revision of the SmPC has also been updated.

Updated on 15 January 2021

File name

Ofev 100 mg PIL for II-34 II-38 PSUSA Jan 21_1610708977.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 14 January 2021

File name

O3-All-SPC-17 - For medicines.ie_1610644507.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • 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)

Free text change information supplied by the pharmaceutical company

Update to section 4.4 to add information on ischaemic colitis.

Update to section 4.6 with regards to fertility, pregnancy and lactation information.

Update to section 4.5 and 5.2 with information on concomitant treatment with oral hormonal contraceptives.

Update to section 5.1 to add results/data from the INSTAGE clinical study.

Editorial updates to sections 2, 3, 4.8, 6.1 and 6.5

Section 10 date of revision has been updated

Updated on 15 December 2020

File name

O3-All-SPC-16-med.ie_1608031334.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)

Updated on 29 September 2020

File name

100 mg text IG-1293_1601397344.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 24 July 2020

File name

100 mg text variation 27 SSc-ILD_1595578615.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 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 23 July 2020

File name

O3-All-SPC-15-Approved_1595510609.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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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)

Free text change information supplied by the pharmaceutical company

4.1

New Indication - Treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype in adults.

4.2

  • Addition of information in the ‘Dose adjustments’ sub-section in case of diarrhoea, nausea and/or vomiting.
  • Removal of information in sub-sections ‘Renal impairment’ & ‘Hepatic impairment’ with cross-reference to section 5.2.
  • Other editorial update.

4.4

  • Where applicable in some sub-sections, specific references made to the INPULSIS and SENSCIS trials have been removed and/or replaced with general reference to ‘clinical trials’, including update to the relevant data.
  • Where applicable in some sub-sections, information regarding the INBUILD trial has been added along with INPULSIS and/or SENSCIS trials.
  • Removal of information regarding the INJOURNEY trial from the sub-section ‘Co-administration with pirfenidone’.

Other editorial updates.

4.8

  • Addition of side-effects and frequency related to the new indication (Other chronic fibrosing ILDs with a progressive phenotype).
  • Where applicable, removal of specific references made to the INPULSIS and SENSCIS trials including relevant data.
  • Where applicable, information regarding the INBUILD trial has been added along with INPULSIS and/or SENSCIS trials.
  • Addition of clinical trial and post marketing information related to ‘Bleeding’.
  • Other editorial updates.

5.1

  • Updates (including editorial) to information in the sub-section ‘IPF’ under ‘Clinical efficacy and safety’.
  • Addition of information related to the new indication (Other chronic fibrosing ILDs with a progressive phenotype) under ‘Clinical efficacy and safety’.
  • Editorial updates in the sub-section ‘SSc-ILD’ under ‘Clinical efficacy and safety’.

5.2

  • Consequential editorial update related to the new indication (Other chronic fibrosing ILDs with a progressive phenotype).
  • Addition of information related toExposure-response relationship’.

5.3

Editorial updates.

6.5

Editorial updates.

10

Date of revision has been updated to 13 July 2020.

Updated on 04 May 2020

File name

100 mg text variation 26 SSc-ILD_1588603842.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 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 04 May 2020

File name

O3-All-SPC-14 - Approved _1588602266.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • 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

Section 4.1: New Indication - Treatment of Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) in adults.

Section 4.2: Consequential changes related to new Indication & other editorial changes.

Section 4.3: Addition of ‘Pregnancy’ as a contraindication with cross-reference to section 4.6.

Section 4.4: Editorial updates and clarifications throughout section 4.4 to the information related to the INPULSIS trial + Addition of information throughout section 4.4 related to the SENSCIS trial + addition of a warning related to ‘Pulmonary hypertension’ & other editorial changes.

Section 4.5: Addition of information regarding co-administration of nintedanib with bosentan.

Section 4.6: Update to information related to Women of childbearing potential/Contraception + Consequential update to section 4.3 regarding the information related to pregnancy.

Section 4.8: Addition of side-effects and frequency related to the new indication (SSc-ILD) + Editorial updates and clarifications to the information related to the INPULSIS trial + Addition of information related to the SENSCIS trial & Other editorial changes.

Section 5.1: Update to information in the sub sections ‘Mechanism of action’ and ‘Pharmacodynamic effects’ + Addition of information related to the new indication (SSc-ILD) & Other editorial changes.

Section 5.2: Consequential editorial updates related to the new indication (SSc-ILD) + Addition of information related to Concomitant treatment with bosentan & Other editorial changes.

Section 10: Date of revision has been updated to 17 April 2020 to align with Commission decision date.

 

 

Updated on 20 January 2020

File name

Ofev 100 mg PIL annex text - WS 1722)_1579532205.pdf

Reasons for updating

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

Updated on 20 January 2020

File name

O3-All-SPC-13 medicines.ie_1579529906.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)

Free text change information supplied by the pharmaceutical company

Section 4.8 of the SmPC has been updated to include new ADRs headache and alopecia 

A further editorial change has been made to section 4.8

Section 10 date of revision has been updated 

Updated on 16 October 2019

File name

100 mg annex text - renewal_1571229426.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 - what the product contains
  • Removal of Black Inverted Triangle

Updated on 15 October 2019

File name

O3-All-SPC-12-medicines.ie_1571152532.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 8 - Marketing authorisation number(s)
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

  • Deletion of the black triangle warning.
  • Section 2, 3, 6.5, 8: Formatting/ editorial changes to include subheadings for Ofev 100mg and Ofev 150mg.
  • Section 4.1, 4.4, 4.8, 5.1: Minor editorial changes to the text.
  • Section 9: Addition of date of last renewal as 23/09/19.
  • Section 10: Date of revision has been updated to 23/09/2019.

Updated on 10 September 2019

File name

Ofev 100 mg PIL annex text_1568125962.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 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 10 September 2019

File name

O3-All-SPC-11_1568123230.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)

Free text change information supplied by the pharmaceutical company

·         Section 4.4 & 4.8: To add a warning and an ADR regarding ‘aneurysms and artery dissections’ (PRAC recommendation to update the product information of respective EU Marketing Authorisation Holders for the class of VEGF inhibitors)

·         Section 4.8: To add ‘colitis’ as an ADR

·         Section 4.8: section 4.8 has also been updated with the revised Irish AE reporting information

·         Section 10: Date of revision has been updated to 04 September 2019 

Updated on 29 November 2018

File name

cropped 100 mg PIL 307433-09 20.11.2018 PIP034477-009_1543501977.pdf

Reasons for updating

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

Updated on 27 November 2018

File name

O3-All-SPC-10_1543314450.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)

Free text change information supplied by the pharmaceutical company

The SmPC has been updated in section 4.8 to add Myocardial infarction as a side effect with a frequency of uncommon.

Section 10 date has been updated.

Updated on 10 August 2018

File name

Ofev 100 mg PIL annex text - PSUSA_1533912418.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 09 August 2018

File name

O3-All-SPC-9_1533818051.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)

Free text change information supplied by the pharmaceutical company

The SmPC has been updated in section 4.4 addition of new text with regards to Renal function and section 4.8 addition of new ADRs: rash (frequency common); pruritus (frequency uncommon); renal failure (frequency not known) following the approval of the PSUSA/00010319/201710.  Section 10 date of revision has been updated.

Updated on 11 July 2018

File name

Ofev 100 mg anx text.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 05 July 2018

File name

O3-All-SPC-8.docx

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 11 June 2018

File name

Ofev 100mg-pil.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 05 June 2018

File name

O3-All-SPC-7.docx

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 20 September 2017

Reasons for updating

  • Improved presentation of PIL

Updated on 20 September 2017

File name

PIL_16272_311.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 August 2017

Reasons for updating

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

Updated on 24 August 2017

Reasons for updating

  • 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 5.2 - 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

Section 4.4 - Special warnings and precautions of the SPC has been updated to include further information under sub-section ‘hepatic function’.  Section 4.8 – Undesirable effects of the SPC has been updated to revise DILI frequency from ‘not known’ to ‘uncommon’.  Section 5.2 - Pharmacokinetic properties of the SPC has been updated to revise the information under sub-section ‘Race’. Section 10 of the SPC has also been revised to include the approval date

Updated on 24 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 10 August 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 08 August 2017

Reasons for updating

  • 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 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

Section 4.4 (Special warnings and precautions) of the SPC has been revised to amend the current warnings regarding diarrhoea, haemorrhage and gastrointestinal perforations. Section 4.8 (Undesirable effects) of the SPC has been updated to add dehydration with an ‘uncommon’ frequency and to add a cross reference to section 4.4 for Bleeding. Section 4.8 has also been updated with regards to contact information for reporting adverse reactions.  Section 10 of the SPC has also been revised to include the approval date

Updated on 16 February 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Improved presentation of PIL

Updated on 31 January 2017

Reasons for updating

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

Updated on 30 January 2017

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

Section 3 (Pharmaceutical form) has been updated to include the term capsule.

Section 4.4 (Special warnings and precautions for use) has been updated to amend the current warning on hepatic function to add that administration of nintedanib was also associated with drug-induced liver injury.

Section 4.8 (Undesirable effects) has been updated to add:
-
drug-induced liver injury as a new adverse drug reaction with a ‘not known’ frequency
-
thrombocytopenia as a new adverse drug reaction with a frequency 'uncommon' under the System Organ Class  ‘Blood and lymphatic system disorders’.

Section 10 (Date of revision of the text) has been updated.

Updated on 28 September 2016

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)

Free text change information supplied by the pharmaceutical company

Section 4.2 and section 4.4 Updated to include revised dose recommendations for pateints with mild hepatic impairment (Child Pugh A).

Section 10 - date of revision amended.

Updated on 05 September 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 23 August 2016

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)

Free text change information supplied by the pharmaceutical company

Section 4.8 (Undesirable effects) of the SPC has been updated to add bleeding with a frequency common and to delete epistaxis under the ‘Vascular disorders’ System Organ Class (SOC) and to add pancreatitis with a frequency uncommon under the ‘Gastrointestinal Disorders’ SOC.  The wording for the description of the source of information in Table 1 – Summary of ADRs has been revised to include ‘or from the postmarketing period’.  Section 10 of the SPC has also been revised.

Updated on 18 March 2016

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 29 February 2016

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 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

Changes made to sections 1, 2, 3, 6.5 and section 8 resulting from the 100 mg and 150 mg SPCs being combined into a single consolidated SPC.

Sections 4.2, 4.4 and 5.2 - changes have been introduced regarding hepatic function and impairment.

Section 9 information expressed more clearly.

Section 10 - date of revision amended.

Updated on 05 February 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 01 February 2016

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)

Free text change information supplied by the pharmaceutical company

The update affects sections 4.4 and 4.8 of the SPC. Section 10 has been updated accordingly.

Updated on 14 April 2015

Reasons for updating

  • Addition of legal category

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

Free text change information supplied by the pharmaceutical company

Legal category changed to restricted medical prescription

Updated on 30 March 2015

Reasons for updating

  • New PIL for new product

Updated on 30 March 2015

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