Dimethyl fumarate

Human medicines European public assessment report (EPAR): Dimethyl fumarate Mylan, dimethyl fumarate, Date of authorisation: 13/05/2022, Revision: 5, Status: Withdrawn

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, INN, Dimethyl fumarate, Multiple sclerosis, ATC, Justice, International, Language, Civil service commission, Medicine, Select, Patient, Anatomy, Commission, IIA, Judgement

Select 'available languages' to access the language you need.

Key Points: 
  • Select 'available languages' to access the language you need.
  • Product information documents contain:
    - summary of product characteristics (annex I);
    - manufacturing authorisation holder responsible for batch release (annex IIA);
    - conditions of the marketing authorisation (annex IIB);
    - labelling (annex IIIA);
    - package leaflet (annex IIIB).
  • Dimethyl fumarate Mylan : EPAR - All authorised presentations
    Product details
    - Name of medicine
    - Dimethyl fumarate Mylan
    - Active substance
    - dimethyl fumarate
    - International proprietary name (INN) or common name
    - dimethyl fumarate
    - Therapeutic area (MeSH)
    - Multiple Sclerosis, Relapsing-Remitting
    - Anatomical therapeutic chemical (ATC) code
    - L04AX07
    Pharmacotherapeutic groupImmunosuppressants
    Therapeutic indication
    Dimethyl fumarate Mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
  • Assessment history
    This page was last updated on

Human medicines European public assessment report (EPAR): Dimethyl fumarate Polpharma, dimethyl fumarate, Date of authorisation: 13/05/2022, Revision: 5, Status: Withdrawn

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, INN, Dimethyl fumarate, Multiple sclerosis, ATC, Justice, International, Language, Civil service commission, Medicine, Select, Patient, Anatomy, Commission, IIA, Judgement, Petrochemical

Select 'available languages' to access the language you need.

Key Points: 
  • Select 'available languages' to access the language you need.
  • Product information documents contain:
    - summary of product characteristics (annex I);
    - manufacturing authorisation holder responsible for batch release (annex IIA);
    - conditions of the marketing authorisation (annex IIB);
    - labelling (annex IIIA);
    - package leaflet (annex IIIB).
  • Dimethyl fumarate Polpharma : EPAR - All authorised presentations
    Product details
    - Name of medicine
    - Dimethyl fumarate Polpharma
    - Active substance
    - dimethyl fumarate
    - International proprietary name (INN) or common name
    - dimethyl fumarate
    - Therapeutic area (MeSH)
    - Multiple Sclerosis, Relapsing-Remitting
    - Anatomical therapeutic chemical (ATC) code
    - L04AX07
    Pharmacotherapeutic groupImmunosuppressants
    Therapeutic indication
    Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
  • Assessment history
    This page was last updated on

Human medicines European public assessment report (EPAR): Dimethyl fumarate Accord, dimethyl fumarate, Date of authorisation: 15/02/2023, Status: Withdrawn

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, INN, Dimethyl fumarate, Multiple sclerosis, ATC, Justice, International, RRMS, Ageing, Language, Civil service commission, Select, Patient, Anatomy, Commission, Sclerosis, Accord, IIA, Judgement, Petrochemical

Overview

Key Points: 
  • Overview
    This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works Polpharma, Cases C-438/21 P to C-440/21 P.
    Dimethyl fumarate Accord : EPAR - Medicine overview
    Product information
    Dimethyl fumarate Accord : EPAR - Product information
    13/12/2023
    This medicine’s product information is available in all official EU languages.
  • Select 'available languages' to access the language you need.
  • Product information documents contain:
    - summary of product characteristics (annex I);
    - manufacturing authorisation holder responsible for batch release (annex IIA);
    - conditions of the marketing authorisation (annex IIB);
    - labelling (annex IIIA);
    - package leaflet (annex IIIB).
  • Dimethyl fumarate Accord : EPAR - All Authorised presentations
    Product details
    - Name of medicine
    - Dimethyl fumarate Accord
    - Active substance
    - dimethyl fumarate
    - International proprietary name (INN) or common name
    - dimethyl fumarate
    - Therapeutic area (MeSH)
    - Multiple Sclerosis, Relapsing-Remitting
    - Multiple Sclerosis
    - Anatomical therapeutic chemical (ATC) code
    - L04AX07
    Pharmacotherapeutic groupImmunosuppressants
    Therapeutic indication
    Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Human medicines European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm, dimethyl fumarate, Date of authorisation: 13/05/2022, Revision: 5, Status: Withdrawn

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, Dimethyl fumarate, Multiple sclerosis, EMEA, ATC, Justice, International, Language, Civil service commission, Medicine, Select, Patient, Anatomy, Commission, IIA, Judgement, Petrochemical

Overview

Key Points: 
  • Overview
    This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works Polpharma, Cases C-438/21 P to C-440/21 P.
    Dimethyl fumarate Neuraxpharm : EPAR - Medicine Overview
    Product information
    Dimethyl fumarate Neuraxpharm : EPAR - Product Information
    Latest procedure affecting product information: EMEA/H/C/006039
    13/12/2023
    This medicine’s product information is available in all official EU languages.
  • Select 'available languages' to access the language you need.
  • Product information documents contain:
    - summary of product characteristics (annex I);
    - manufacturing authorisation holder responsible for batch release (annex IIA);
    - conditions of the marketing authorisation (annex IIB);
    - labelling (annex IIIA);
    - package leaflet (annex IIIB).
  • Dimethyl fumarate Neuraxpharm : EPAR - All authorised presentations
    Product details
    - Name of medicine
    - Dimethyl fumarate Neuraxpharm
    - Active substance
    - dimethyl fumarate
    - International proprietary name (INN) or common name
    - dimethyl fumarate
    - Therapeutic area (MeSH)
    - Multiple Sclerosis, Relapsing-Remitting
    - Anatomical therapeutic chemical (ATC) code
    - L04AX07
    Pharmacotherapeutic groupImmunosuppressants
    Therapeutic indication
    Dimethyl fumarate Neuraxpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Human medicines European public assessment report (EPAR): Dimethyl fumarate Teva, dimethyl fumarate, Date of authorisation: 12/12/2022, Date of refusal: 12/12/2023, Status: Withdrawn

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, INN, Dimethyl fumarate, Teva, Multiple sclerosis, ATC, Justice, International, RRMS, Ageing, Language, Civil service commission, Select, Patient, Anatomy, Commission, Sclerosis, IIA, Judgement

Select 'available languages' to access the language you need.

Key Points: 
  • Select 'available languages' to access the language you need.
  • Product information documents contain:
    - summary of product characteristics (annex I);
    - manufacturing authorisation holder responsible for batch release (annex IIA);
    - conditions of the marketing authorisation (annex IIB);
    - labelling (annex IIIA);
    - package leaflet (annex IIIB).
  • Dimethyl fumarate Teva: EPAR - All authorised presentations
    Product details
    - Name of medicine
    - Dimethyl fumarate Teva
    - Active substance
    - dimethyl fumarate
    - International proprietary name (INN) or common name
    - dimethyl fumarate
    - Therapeutic area (MeSH)
    - Multiple Sclerosis, Relapsing-Remitting
    - Multiple Sclerosis
    - Anatomical therapeutic chemical (ATC) code
    - L04AX07
    Pharmacotherapeutic groupImmunosuppressants
    Therapeutic indication
    Dimethyl fumarate Teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
  • Assessment history
    This page was last updated on

Centralized Marketing Authorizations of Generic Versions of TECFIDERA® are Revoked by the European Commission

Retrieved on: 
Tuesday, December 19, 2023
Marketing, Biogen, European Commission, BIIB, Sale, Dimethyl fumarate, Civil service commission

CAMBRIDGE, Mass., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of Biogen’s product TECFIDERA® (dimethyl fumarate) held by Accord, Mylan, Neuraxpharm, Polpharma and Teva.

Key Points: 
  • CAMBRIDGE, Mass., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission has revoked the centralized marketing authorizations for generic versions of Biogen’s product TECFIDERA® (dimethyl fumarate) held by Accord, Mylan, Neuraxpharm, Polpharma and Teva.
  • In reaching this decision, the European Commission affirmed that Biogen is entitled to full data protection and marketing protection for TECFIDERA.
  • Biogen welcomes the actions of the European Commission, which confirm the laws governing data exclusivity and marketing protection.
  • Biogen has sufficient supply of TECFIDERA to supply the entire European market.

European Commission revokes all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm

Retrieved on: 
Wednesday, December 20, 2023
General Court, European Commission, Dimethyl fumarate, Justice, European, Civil service commission, DMF, European Medicines Agency, Public, CNS, Face, Central nervous system, Patient, Commission, Pressure, Judgement

BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.

Key Points: 
  • BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.
  • This decision contradicts the European Medicines Agency's own prior scientific review, when the Commission granted an unconditional marketing permission to Neuraxpharm in 2022.
  • Neuraxpharm will swiftly contest this decision at the General Court of the European Union, with the aim of reintroducing Dimethyl Fumarate Neuraxpharm to the European market as soon as possible.
  • Neuraxpharm remains committed to our mission of providing affordable, high-quality medication to patients across the European Union, including patients who depend on the more affordable generic versions of Tecfidera such as Dimethyl Fumarate Neuraxpharm."

European Commission revokes all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm

Retrieved on: 
Wednesday, December 20, 2023
General Court, European Commission, Dimethyl fumarate, Justice, European, Civil service commission, DMF, European Medicines Agency, Public, CNS, Face, Central nervous system, Patient, Commission, Pressure, Judgement

BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.

Key Points: 
  • BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.
  • This decision contradicts the European Medicines Agency's own prior scientific review, when the Commission granted an unconditional marketing permission to Neuraxpharm in 2022.
  • Neuraxpharm will swiftly contest this decision at the General Court of the European Union, with the aim of reintroducing Dimethyl Fumarate Neuraxpharm to the European market as soon as possible.
  • Neuraxpharm remains committed to our mission of providing affordable, high-quality medication to patients across the European Union, including patients who depend on the more affordable generic versions of Tecfidera such as Dimethyl Fumarate Neuraxpharm."

Discovery of Genetic Link to PML Honored by Largest MS Conference in the World

Retrieved on: 
Tuesday, October 17, 2023
Emerald, Dimethyl fumarate, DRS, Best, FAERS, Great America Committee, Cladribine, MS, Research, JC, Abstract, Brain, Biogen, Breast cancer, COVID, Multiple myeloma, Treatment, Daratumumab, Risk, CLIA, Natalizumab, Multiple sclerosis, Discovery, Belimumab, Death, Health, PML, Disease, American Neurological Association, Rheumatoid arthritis, FDA, Database, Gene, Human polyomavirus 2, BRCA, Bone marrow, Black box, Inflammatory bowel disease, Infection, PPV, Ibrutinib, Rituximab, Lupus, Progressive multifocal leukoencephalopathy, HIV/AIDS, Patient, Pharmaceutical industry

NEWPORT BEACH, Calif., Oct. 17, 2023 /PRNewswire/ -- The discovery of rare genomic variants leading to cases of drug-induced PML shared Best of MSMilan2023 honors for the latest and most breakthrough results at the 9th Joint ECTRIMS-ACTRIMS Meeting.

Key Points: 
  • Two of the variants have a Positive Predictive Value of 100%, the strongest possible indication they are causative.
  • Progressive Multifocal Leukoencephalopathy (PML) is a rare but frequently fatal serious infection of the brain by the JC virus.
  • Out of 1,500 abstracts presented, Dr. Hatchwell's was one of eight highlighted as Best of MSMilan2023 in its content area.
  • Many MS medications currently carry a PML warning, including Tysabri, Ocrevus, and Rituxan, as well as Briumvi, Gilenya, Kesimpta, Mavenclad, Mayzent, Ponvory, and Tecfidera.

Alltrna Expands Leadership Team with Appointments of Chief Scientific Officer and Chief Technology Officer

Retrieved on: 
Tuesday, August 15, 2023
Molecule, Columbia University, Medicinal chemistry, University, Pasteur Institute, Duke University, Dimethyl fumarate, Therapy, Spinal muscular atrophy, Small RNA, Disease, Development, Biogen, University of Cambridge, CMC, Coronavirus Scientific Advisory Board, Research, RNA, Multiple sclerosis, Movement disorder, Chemistry, DSM-IV codes, Publication, Flagship Pioneering, Pasteur Institute of Iran, Ophthalmology, Biology, Entrepreneurship, SVP, Nusinersen, Rest, ALS, Management, Pharmaceutical industry, Trophos

Dr. Henderson was formerly Senior Vice President, Head of Research at Biogen, and Dr. Kiesman was Senior Vice President, CMC and Medicinal Chemistry at Alltrna.

Key Points: 
  • Dr. Henderson was formerly Senior Vice President, Head of Research at Biogen, and Dr. Kiesman was Senior Vice President, CMC and Medicinal Chemistry at Alltrna.
  • "Chris' deep scientific expertise and experience advancing programs into the clinic across a wide range of disease areas will be invaluable.
  • Will has significantly advanced our internal medicinal chemistry programs and developed a flexible manufacturing strategy to scale and deliver engineered tRNAs.
  • Dr. Henderson has more than 90 scientific research publications and been an editor and reviewer for top-tier scientific journals.