Arava 20 mg film-coated tablets
*Company:
SANOFIStatus:
UpdatedLegal 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
1.3.1.1 SmPC Arava 20mg IE (2).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 22 October 2024
File name
1.3.2.1 Mock-up Leaflet Arava 20mg IE (1).pdf
Reasons for updating
- 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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
Updated on 22 August 2024
File name
1.3.1.1 SmPC Arava 20mg IE.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 August 2024
File name
1.3.1.1 SmPC Arava 20mg GB.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 August 2024
File name
1.3.1.1 SmPC Arava 10mg IE.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
Arava RMP patient leaflet (Ireland)_Nov_23.pdf
Reasons for updating
- Replace File
File name
Arava physician leaflet (Ireland)_Nov_23.pdf
Reasons for updating
- Replace File
Updated on 12 July 2023
File name
1.3.2 Mock-up PIL 20mg IE.pdf
Reasons for updating
- Improved presentation of PIL
File name
RMP Arava- Patient leaflet v3_Final.pdf
Reasons for updating
- Add New Doc
File name
Arava Physician leaflet revised 2015 clean 08Apr15.pdf
Reasons for updating
- Add New Doc
Updated on 05 April 2022
File name
PIL text Arava 20mg IE_Clean_S22.120.pdf
Reasons for updating
- 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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 05 April 2022
File name
SPC Arava 20mg IE_Clean_S22.120.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 October 2021
File name
1.3.1 PIL text 20mg IE Approved on 03 August 2021 - S21.608.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 09 November 2020
File name
1.3.1 PIL text 20mg UKIE.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 06 July 2020
File name
1.3.2 Mock-up PIL 20mg IE.pdf
Reasons for updating
- XPIL Removed
Updated on 17 March 2020
File name
1.3.2 Mock-up PIL 20mg IE.pdf
Reasons for updating
- Change in co-marketing arrangement
Free text change information supplied by the pharmaceutical company
Article 61.3 notification to update of the local representatives in Malta
Updated on 16 October 2019
File name
Arava 20mg SPC.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 08 October 2019
File name
Arava PIL 20mg IE.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 13 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 December 2017
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
Section4.4 added:-
Interference with determination of ionised calcium levels
The measurement of ionised calcium levels might show falsely decreased values under treatment with leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised calcium analyser used (e.g. blood gas analyser). Therefore, the plausibility of observed decreased ionised calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide. In case of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium concentration.
Updated on 11 December 2017
File name
PIL_10437_453.pdf
Reasons for updating
- New PIL for new product
Updated on 11 December 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 03 August 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 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
Respiratory reactions
Interstitial lung disease, as well as rare cases of pulmonary hypertension have been reported during treatment with leflunomide (see section 4.8).
Updated on 12 February 2016
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 24 November 2015
Reasons for updating
- 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.3- Formatted text
4.4- Formatted text and Colitis reported in patients treated with leflunomide
4.5- Formatted text
4.6- Adverse effects on male reproductive organs were observed (animals)
4.8- Colitis added
5.2- Formatted text
6.4- Wording update.
Updated on 13 November 2015
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to dosage and administration
- Addition of information on reporting a side effect.
- Correction of spelling/typing errors
Updated on 03 February 2015
Reasons for updating
- Change to side-effects
Updated on 07 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to further information section
- Change to date of revision
Updated on 10 October 2014
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 June 2014
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 30 May 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 26 February 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 20 February 2014
Reasons for updating
- Change to side-effects
Updated on 12 April 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 14 January 2013
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 21 September 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 01 June 2011
Reasons for updating
- Improved electronic presentation
Updated on 21 March 2011
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 May 2008
Reasons for updating
- Change to side-effects
- Improved electronic presentation
- Joint PIL superseded by PILs for individual presentations
Updated on 18 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 20 March 2006
Reasons for updating
- Improved electronic presentation
Updated on 28 September 2005
Reasons for updating
- New PIL for medicines.ie