Dimethyl fumarate Polpharma
Revoked
This medicine's authorisation has been revoked
dimethyl fumarate
MedicineHumanRevoked
- Application under evaluation
- CHMP opinion
- European Commission decision
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This marketing authorisation has been revoked by the European Commission in order to implement the judgment of the Court of Justice of 16 March 2023 in Commission and Others v Pharmaceutical Works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 Polpharma : EPAR - Medicine Overview
Reference Number: EMA/127784/2022
English (EN) (215.8 KB - PDF)
First published:
български (BG) (295.44 KB - PDF)
First published: 22/12/2023
español (ES) (250.19 KB - PDF)
First published: 22/12/2023
čeština (CS) (286.37 KB - PDF)
First published: 22/12/2023
dansk (DA) (236.77 KB - PDF)
First published: 22/12/2023
Deutsch (DE) (251.13 KB - PDF)
First published: 22/12/2023
eesti keel (ET) (225.02 KB - PDF)
First published: 22/12/2023
ελληνικά (EL) (309.33 KB - PDF)
First published: 22/12/2023
français (FR) (250.3 KB - PDF)
First published: 22/12/2023
hrvatski (HR) (265.42 KB - PDF)
First published: 22/12/2023
italiano (IT) (243.36 KB - PDF)
First published: 22/12/2023
latviešu valoda (LV) (288.81 KB - PDF)
First published: 22/12/2023
lietuvių kalba (LT) (271.62 KB - PDF)
First published: 22/12/2023
magyar (HU) (278.68 KB - PDF)
First published: 22/12/2023
Malti (MT) (280.66 KB - PDF)
First published: 22/12/2023
Nederlands (NL) (247.71 KB - PDF)
First published: 22/12/2023
polski (PL) (284.84 KB - PDF)
First published: 22/12/2023
português (PT) (242.74 KB - PDF)
First published: 22/12/2023
română (RO) (276.97 KB - PDF)
First published: 22/12/2023
slovenčina (SK) (276.74 KB - PDF)
First published: 22/12/2023
slovenščina (SL) (266.21 KB - PDF)
First published: 22/12/2023
Suomi (FI) (242.72 KB - PDF)
First published: 22/12/2023
svenska (SV) (236.88 KB - PDF)
First published: 22/12/2023
Dimethyl fumarate Polpharma : EPAR - Risk management plan summary
English (EN) (176.59 KB - PDF)
First published:
Product information
Dimethyl fumarate Polpharma : EPAR - Product Information
English (EN) (475.68 KB - PDF)
First published:
български (BG) (599.15 KB - PDF)
First published: 22/12/2023
español (ES) (532.62 KB - PDF)
First published: 22/12/2023
čeština (CS) (2.11 MB - PDF)
First published: 22/12/2023
dansk (DA) (527.09 KB - PDF)
First published: 22/12/2023
Deutsch (DE) (579.06 KB - PDF)
First published: 22/12/2023
eesti keel (ET) (500.19 KB - PDF)
First published: 22/12/2023
ελληνικά (EL) (634.2 KB - PDF)
First published: 22/12/2023
français (FR) (603.04 KB - PDF)
First published: 22/12/2023
hrvatski (HR) (511.92 KB - PDF)
First published: 22/12/2023
íslenska (IS) (516.08 KB - PDF)
First published: 22/12/2023
italiano (IT) (526.88 KB - PDF)
First published: 22/12/2023
latviešu valoda (LV) (537.43 KB - PDF)
First published: 22/12/2023
lietuvių kalba (LT) (511.23 KB - PDF)
First published: 22/12/2023
magyar (HU) (608.46 KB - PDF)
First published: 22/12/2023
Malti (MT) (576 KB - PDF)
First published: 22/12/2023
Nederlands (NL) (513.42 KB - PDF)
First published: 22/12/2023
norsk (NO) (536.06 KB - PDF)
First published: 22/12/2023
polski (PL) (573.68 KB - PDF)
First published: 22/12/2023
português (PT) (526.14 KB - PDF)
First published: 22/12/2023
română (RO) (503.34 KB - PDF)
First published: 22/12/2023
slovenčina (SK) (533.63 KB - PDF)
First published: 22/12/2023
slovenščina (SL) (525.98 KB - PDF)
First published: 22/12/2023
Suomi (FI) (553.19 KB - PDF)
First published: 22/12/2023
svenska (SV) (526.86 KB - PDF)
First published: 22/12/2023
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 Polpharma : EPAR - All authorised presentations
English (EN) (88.44 KB - PDF)
First published:
български (BG) (116.23 KB - PDF)
First published: 22/12/2023
español (ES) (107.24 KB - PDF)
First published: 22/12/2023
čeština (CS) (108.02 KB - PDF)
First published: 22/12/2023
dansk (DA) (89.31 KB - PDF)
First published: 22/12/2023
Deutsch (DE) (89.64 KB - PDF)
First published: 22/12/2023
eesti keel (ET) (88.95 KB - PDF)
First published: 22/12/2023
ελληνικά (EL) (106.66 KB - PDF)
First published: 22/12/2023
français (FR) (87.91 KB - PDF)
First published: 22/12/2023
hrvatski (HR) (102.01 KB - PDF)
First published: 22/12/2023
íslenska (IS) (87.04 KB - PDF)
First published: 22/12/2023
italiano (IT) (89.13 KB - PDF)
First published: 22/12/2023
latviešu valoda (LV) (100.16 KB - PDF)
First published: 22/12/2023
lietuvių kalba (LT) (101.62 KB - PDF)
First published: 22/12/2023
magyar (HU) (102.46 KB - PDF)
First published: 22/12/2023
Malti (MT) (99 KB - PDF)
First published: 22/12/2023
Nederlands (NL) (89.24 KB - PDF)
First published: 22/12/2023
norsk (NO) (86.7 KB - PDF)
First published: 22/12/2023
polski (PL) (100.67 KB - PDF)
First published: 22/12/2023
português (PT) (87.61 KB - PDF)
First published: 22/12/2023
română (RO) (95.68 KB - PDF)
First published: 22/12/2023
slovenčina (SK) (98.99 KB - PDF)
First published: 22/12/2023
slovenščina (SL) (89.34 KB - PDF)
First published: 22/12/2023
Suomi (FI) (88.23 KB - PDF)
First published: 22/12/2023
svenska (SV) (88.01 KB - PDF)
First published: 22/12/2023
Product details
- Name of medicine
- Dimethyl fumarate Polpharma
- Active substance
- dimethyl fumarate
- International non-proprietary name (INN) or common name
- dimethyl fumarate
- Therapeutic area (MeSH)
- Multiple Sclerosis, Relapsing-Remitting
- Anatomical therapeutic chemical (ATC) code
- L04AX07
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
Authorisation details
- EMA product number
- EMEA/H/C/005955
Generic
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
- Marketing authorisation holder
- Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
Ul. Pelplinska 19
83-200 Starogard
Gdanski
Poland - Opinion adopted
- 24/02/2022
- Marketing authorisation issued
- 13/05/2022
- Revocation of marketing authorisation
- 13/12/2023
- Revision
- 5
Assessment history
Dimethyl fumarate Polpharma : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (748.4 KB - PDF)
First published:
News on Dimethyl fumarate Polpharma
More information on Dimethyl fumarate Polpharma
Public statement on Dimethyl fumarate Polpharma : Revocation of the marketing authorisation in the European Union
English (EN) (126.72 KB - PDF)
First published:
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