AUBAGIO 14 mg film-coated tablets
*Company:
Sanofi GenzymeStatus:
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
File name
Patient Card - Aubagio IE (1).pdf
Reasons for updating
- Replace File
Updated on 01 October 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (6).pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 September 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (5).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 August 2024
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 14mg (3).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 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 01 August 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (4).pdf
Reasons for updating
- 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)
File name
HCP Guide - Aubagio IE.pdf
Reasons for updating
- Replace File
File name
Patient Card - Aubagio IE.pdf
Reasons for updating
- Replace File
Updated on 07 May 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (3).pdf
Reasons for updating
- 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 May 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 June 2023
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 14mg.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 28 March 2023
File name
1.3.2.1 Mock-up - Package Leaflet (PIL)- Aubagio 7mg.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 29 November 2022
File name
1.3.1 SmPC IENIMalta (1).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 January 2022
File name
1.3.2.1 Mock-up Leaflet - 14MG - IE-MT-UK(NI).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
File name
AUB-2021-061_HCP_Discussion_Guide_IE_V7.pdf
Reasons for updating
- Replace File
File name
AUB-2021-060_Aubagio_Patient_Card_IE_MAT-IE-2101438 v2.0.pdf
Reasons for updating
- Replace File
Updated on 13 September 2021
File name
1.3.2.1 Mock-up Leaflet - IE-MT (2).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 09 September 2021
File name
Aubagio 1.3.2.1 Mock-up Leaflet - IE-MT (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
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- 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 27 July 2021
File name
1.3.1 SmPC IENIMalta (2).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 13 July 2021
File name
1.3.1 SmPC IENIMalta (1).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 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 5.1 - 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 July 2021
File name
1.3.2.1 Mock-up Leaflet - IE-MT.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 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
- 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 22 June 2021
File name
1.3.1 SmPC IENIMalta.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 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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 5.1 - 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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 March 2021
File name
1.3.2.1 Mock-up Leaflet - IE-MT (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 15 February 2021
File name
1.3.1 SPC (7).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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 15 February 2021
File name
1.3.1 Leaflet text IEMT (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
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 09 November 2020
File name
1.3.2 PIL Mock-up IE-MT.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 September 2020
File name
1.3.1 SPC (3).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
|
Updated on 16 September 2020
File name
1.3.1 PIL (5).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
File name
AUB-2020-009_HCP_Discussion_Guide_IE_2pp 12.6.20.pdf
Reasons for updating
- Replace File
File name
AUB-2020-010_Patient_Alert_Card_IE 12.6.20.pdf
Reasons for updating
- Replace File
File name
AUB-2020-009_HCP_Discussion_Guide_IE_2pp 12.6.20.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
To increase patients’ knowledge about symptoms of liver problems and infections in the patient Card
• To add instructions to the HCPs regarding the enrolment of patients in the pregnancy registry in the HCP Guide
• To ensure that the content of Patient Card will be discussed by the HCP during each regularly during each consultation
File name
AUB-2020-010_Patient_Alert_Card_IE 12.6.20.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
To increase patients’ knowledge about symptoms of liver problems and infections in the patient Card
• To add instructions to the HCPs regarding the enrolment of patients in the pregnancy registry in the HCP Guide
Updated on 20 November 2019
File name
Aubagio PIL.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 15 November 2019
File name
Aubagio PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 11 November 2019
File name
Aubagio SPC.pdf
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)
Updated on 11 November 2019
File name
Aubagio PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
File name
AUB-2018-017_RMP_Updates_-_HCP_Education_Guide.pdf
Reasons for updating
- Add New Doc
File name
AUB-2018-017_RMP_Updates_-_Patient_card.pdf
Reasons for updating
- Add New Doc
Updated on 24 May 2019
File name
PIL mock up Aubagio reissue SA1216.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 22 May 2019
File name
PIL Aubagio 14mg fc tablets SA1216.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 22 May 2019
File name
SPC Aubagio 14mg fc tablets SA1216.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
Section 4.4
update with a warning concerning alcohol use with clarification of "with caution" term
Updated on 04 April 2019
File name
PIL Mock-up Aubagio SA1098.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 08 March 2019
File name
PIL Aubagio 14mg film coated tablets SA1098.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 08 March 2019
File name
SPC Aubagio 14mg film coated tablet SA1098.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)
Free text change information supplied by the pharmaceutical company
|
Metabolism and nutrition disorders |
|
|
|
|
|
Dyslipidaemia |
|
Skin and subcutaneous tissue disorders |
Alopecia |
Rash, Acne |
Nail disorders |
|
|
Severe skin reactionsa
|
|
Musculoskeletal and connective tissue disorders |
|
Musculoskeletal pain, Myalgia, Arthralgia |
|
|
|
|
|
Renal and urinary disorders |
|
Pollakiuria |
|
|
|
|
|
Reproductive system and breast disorders |
|
Menorrhagia |
|
|
|
|
|
General disorders and administration site conditions |
|
Pain, Astheniaa |
|
|
|
|
|
Investigations |
|
Weight decrease, Neutrophil count decreaseb, White blood cell count decreaseb, Blood creatine phosphokinase increased |
|
|
|
|
|
Injury, poisoning and procedural complications |
|
|
Post-traumatic pain |
|
|
|
a: please refer to the detailed description section
b: see section 4.4
Severe skin reactions
Cases of severe skin reactions have been reported with teriflunomide post-marketing (see section 4.4).
Asthenia
In placebo-controlled studies, frequencies for asthenia were 2.0%, 1.6% and 2.2% in the placebo, teriflunomide 7 mg and teriflunomide 14 mg group, respectively.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
4.9 Overdose
Long term follow-up results from TEMSO long term extension safety study (overall median treatment duration approximately 5 years, maximum treatment duration approximately 8.5 years) did not present any new or unexpected safety findings.
Updated on 21 December 2018
File name
PIL Mock up Aubagio 14mg film coated tablets.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 21 December 2018
File name
SPC Aubagio 14mg film coated tablet .pdf
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
|
Hepatobiliary disorders |
Alanine aminotransferase (ALT) increaseb |
Gamma-glutamyltransferase (GGT) increaseb, Aspartate aminotransferase increaseb |
|
|
|
Acute hepatitis |
|
Metabolism and nutrition disorders |
|
|
|
|
|
Dyslipidaemia |
|
Skin and subcutaneous tissue disorders |
Alopecia |
Rash, Acne |
|
|
|
Severe skin reactionsa Nail disorders |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Updated on 24 October 2018
File name
Aubagio 14mg film-coated tablets PIL.pdf
Reasons for updating
- XPIL Created
Updated on 25 July 2018
File name
Aubagio 14mg film-coated tablets PIL.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 05 June 2018
File name
AUBAGIO 14mg film-coated tablets SPC.docx
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
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
- 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
- Removal of black triangle
Section 4.3 Contraindications
AIDs removed and replaced with acquired immunodeficiency syndrome (AIDS).
Section 4.4 Special warnings and precautions for use
Wording added into section:-
- serum glutamic pyruvic transaminase
- Check periodically
- serum glutamic pyruvic transaminase
- Liver enzymes should be assessed every two weeks during the first 6 months of treatment, and every 8 weeks thereafter or as indicated by clinical signs and symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.
Hepatic effects:-
Wording removed from section:-
- Liver enzymes should be assessed before initiation of teriflunomide therapy - every two weeks during the first 6 months of treatment, and every 8 weeks thereafter or as indicated by clinical signs and symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine. For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.
Subtitle added:-
- Hypoproteinaemia
Respiratory reactions
Amendments to paragraph
- Drug removed and replaced with medicinal product.
- Consider removed and replaced with should be considered.
Lactose
Minor wording amendments to paragraph
Section 4.5 Interaction with other medicinal products and other forms of interaction
Grammatical errors amended and medicinal added into paragraph
Section 4.6 Fertility, pregnancy and lactation
Medicine replaced by medicinal product
Breast-feeding
Added
- Teriflunomide is contraindicated during breast-feeding
- (see section 4.3).
Removed
- women must, therefore, not receive teriflunomide
- Breast
Section 4.7 Effects on ability to drive and use machines
- The word cars removed
Section 4.8 Undesirable effects
- Minor amendments to tabulated list of adverse reactions
Section 5.1 Pharmacodynamic properties
Added:
- Immunosuppressants,
- Minor spelling amendments updated
Section 5.2 Pharmacokinetic properties
- IV replaced with intravenous
Section 6.5 Nature and contents of container
- Aluminium replaced with Polyamide/aluminium/poly(vinyl chloride)
Section 9
- Renewal date added 28May2018
Updated on 05 June 2018
File name
AUGAGIO 14mg film-coated tablets Text Leaflet.pdf
Reasons for updating
- New PIL for new product
Updated on 05 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 July 2017
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
Updated on 05 July 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Updated on 15 May 2017
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)
Free text change information supplied by the pharmaceutical company
Updated on 15 May 2017
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
Free text change information supplied by the pharmaceutical company
Updated on 09 December 2015
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
Section 4.4: Under Skin reactions the following update has been made;
Cases of severe skins reactions have been reported with teriflunomide postmarketing (including Stevens-Johnson syndrome, and toxic epidermal necrolysis).
In patients treated with leflunomide, the parent compound, very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported as well.
Section 4.8: The following additions to the Adverse Reactions table have been made; Headache, palpitations, arthralgia, blood creatine phosphokinase increased.
Addition of terms from post marketing safety reports for teriflunomide also included; Severe infections including sepsis, Hyper-sensitivity reactions (immediate or delayed) including anaphylaxis and angioedema, Pancreatitis, Stomatitis, Severe skin reactions. These terms have all been placed in the new column for frequency ‘Not known’. Consequentially, the following sentence has been added below the ADR table, under the heading for infections: “Severe infections including sepsis, sometimes fatal have been reported post marketing.”
Updated on 09 December 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Section 4.4: Under Skin reactions the following update has been made;
Cases of severe skins reactions have been reported with teriflunomide postmarketing (including Stevens-Johnson syndrome, and toxic epidermal necrolysis).
In patients treated with leflunomide, the parent compound, very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported as well.
Section 4.8: The following additions to the Adverse Reactions table have been made; Headache, palpitations, arthralgia, blood creatine phosphokinase increased.
Addition of terms from post marketing safety reports for teriflunomide also included; Severe infections including sepsis, Hyper-sensitivity reactions (immediate or delayed) including anaphylaxis and angioedema, Pancreatitis, Stomatitis, Severe skin reactions. These terms have all been placed in the new column for frequency ‘Not known’. Consequentially, the following sentence has been added below the ADR table, under the heading for infections: “Severe infections including sepsis, sometimes fatal have been reported post marketing.”
Updated on 08 July 2015
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Skin reactions
No cCases of severe skins reactions have been reported with teriflunomide postmarketing in the clinical trials. In patients treated with leflunomide, the parent compound, very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported as well.
4.8 Undesirable effects
Severe skin reactions
Cases of severe skins reactions have been reported with teriflunomide post-marketing (see section 4.4).
Updated on 08 July 2015
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
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Skin reactions
No cCases of severe skins reactions have been reported with teriflunomide postmarketing in the clinical trials. In patients treated with leflunomide, the parent compound, very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported as well.
4.8 Undesirable effects
Severe skin reactions
Cases of severe skins reactions have been reported with teriflunomide post-marketing (see section 4.4).
Updated on 09 December 2014
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
Section 4.4: Inclusion of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) under the skin reactions section in patients treated with the parent compound leflunomide.
Updated on 09 December 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Section 4.4: Inclusion of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) under the skin reactions section in patients treated with the parent compound leflunomide.
Updated on 07 October 2014
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.5: improvement of the oral contraceptive PK interaction wording.
Section 4.8 update of AEs vs placebo (i.e. data pool of all placebo-controlled phase2/3 clinical trials).
Section 5.1: addition of TOPIC efficacy study results.
Updated on 07 October 2014
Reasons for updating
- 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
Free text change information supplied by the pharmaceutical company
Section 4.5: improvement of the oral contraceptive PK interaction wording.
Section 4.8 update of AEs vs placebo (i.e. data pool of all placebo-controlled phase2/3 clinical trials).
Section 5.1: addition of TOPIC efficacy study results.
Updated on 22 September 2014
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
In section 4.4: Addition of two clinical study results in the vaccination paragraph as below;
From:
Vaccination
In a clinical study, teriflunomide-treated patients mounted appropriate immune responses to a seasonal influenza vaccination, consistent with the preservation of a response to booster vaccine. Patients reached post-vaccination antibody titres, consistent with seroprotection. No clinical data are available on the efficacy and safety of vaccinations regarding primary immune response to neopathogens. The use of live attenuated vaccines may carry a risk of infections and should, therefore, be avoided.
To:
Vaccination
Two clinical studies have shown that vaccinations to inactivated neoantigen (first vaccination), or recall antigen (reexposure) were safe and effective during AUBAGIO treatment . The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided.
Updated on 22 September 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
In section 4.4: Addition of two clinical study results in the vaccination paragraph as below;
From:
Vaccination
In a clinical study, teriflunomide-treated patients mounted appropriate immune responses to a seasonal influenza vaccination, consistent with the preservation of a response to booster vaccine. Patients reached post-vaccination antibody titres, consistent with seroprotection. No clinical data are available on the efficacy and safety of vaccinations regarding primary immune response to neopathogens. The use of live attenuated vaccines may carry a risk of infections and should, therefore, be avoided.
To:
Vaccination
Two clinical studies have shown that vaccinations to inactivated neoantigen (first vaccination), or recall antigen (reexposure) were safe and effective during AUBAGIO treatment . The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided.
Updated on 30 July 2014
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 30 July 2014
Reasons for updating
- New SPC for new product