Overview
The marketing authorisation for Cyltezo has been withdrawn at the request of the marketing-authorisation holder.
Cyltezo : EPAR - Summary for the public
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slovenščina (SL) (269.98 KB - PDF)
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svenska (SV) (227.74 KB - PDF)
Product information
Cyltezo : EPAR - Product Information
English (EN) (1.64 MB - PDF)
български (BG) (2.79 MB - PDF)
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čeština (CS) (2.22 MB - PDF)
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eesti keel (ET) (1.58 MB - PDF)
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italiano (IT) (1.55 MB - PDF)
latviešu valoda (LV) (2.14 MB - PDF)
lietuvių kalba (LT) (1.5 MB - PDF)
magyar (HU) (2.28 MB - PDF)
Malti (MT) (2.34 MB - PDF)
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norsk (NO) (1.5 MB - PDF)
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português (PT) (1.56 MB - PDF)
română (RO) (1.73 MB - PDF)
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slovenščina (SL) (2.09 MB - PDF)
Suomi (FI) (1.42 MB - PDF)
svenska (SV) (1.44 MB - PDF)
Latest procedure affecting product information: IB/0005/G
15/01/2019
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).
Cyltezo : EPAR - All Authorised presentations
English (EN) (150.29 KB - PDF)
български (BG) (162.5 KB - PDF)
español (ES) (149.83 KB - PDF)
čeština (CS) (156.55 KB - PDF)
dansk (DA) (151.26 KB - PDF)
Deutsch (DE) (151.41 KB - PDF)
eesti keel (ET) (148.47 KB - PDF)
ελληνικά (EL) (175.9 KB - PDF)
français (FR) (150.33 KB - PDF)
hrvatski (HR) (149.77 KB - PDF)
íslenska (IS) (150.77 KB - PDF)
italiano (IT) (149.21 KB - PDF)
latviešu valoda (LV) (156.32 KB - PDF)
lietuvių kalba (LT) (149.86 KB - PDF)
magyar (HU) (156.29 KB - PDF)
Malti (MT) (158.14 KB - PDF)
Nederlands (NL) (157.32 KB - PDF)
norsk (NO) (151 KB - PDF)
polski (PL) (156.73 KB - PDF)
português (PT) (150.48 KB - PDF)
română (RO) (150.15 KB - PDF)
slovenčina (SK) (156.49 KB - PDF)
slovenščina (SL) (162.99 KB - PDF)
Suomi (FI) (148.33 KB - PDF)
svenska (SV) (149.67 KB - PDF)
Product details
- Name of medicine
- Cyltezo
- Active substance
- adalimumab
- International non-proprietary name (INN) or common name
- adalimumab
- Therapeutic area (MeSH)
- Hidradenitis Suppurativa
- Arthritis, Psoriatic
- Psoriasis
- Crohn Disease
- Arthritis, Juvenile Rheumatoid
- Uveitis
- Arthritis, Rheumatoid
- Colitis, Ulcerative
- Spondylitis, Ankylosing
- Anatomical therapeutic chemical (ATC) code
- L04AB04
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Please refer to section 4.1 of the Summary of product characteristics in the product information document.
Authorisation details
- EMA product number
- EMEA/H/C/004319
Biosimilar
This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.
- Marketing authorisation holder
- Boehringer Ingelheim International GmbH
Binger Strasse 173 55216
Ingelheim am Rhein
Germany - Marketing authorisation issued
- 10/11/2017
- Revision
- 2
Assessment history
Cyltezo : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (212.2 KB - PDF)
News on Cyltezo
Related content
More information on Cyltezo
Public statement on Cyltezo: Withdrawal of the marketing authorisation in the European Union
English (EN) (76.9 KB - PDF)