Lusduna
Withdrawn
This medicine's authorisation has been withdrawn
insulin glargine
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Lusduna has been withdrawn at the request of the marketing-authorisation holder.
Lusduna : EPAR - Summary for the public
English (EN) (543.64 KB - PDF)
First published: Last updated:
български (BG) (624.41 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
español (ES) (542.41 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
čeština (CS) (608.2 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
dansk (DA) (541.47 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Deutsch (DE) (544.03 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
eesti keel (ET) (539.77 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
ελληνικά (EL) (632.12 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
français (FR) (544.38 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
hrvatski (HR) (565.18 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
italiano (IT) (541.94 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
latviešu valoda (LV) (632.7 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
lietuvių kalba (LT) (566.99 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
magyar (HU) (600.47 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Malti (MT) (610.24 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Nederlands (NL) (541.75 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
polski (PL) (607.74 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
português (PT) (542.49 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
română (RO) (566.2 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
slovenčina (SK) (605.28 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
slovenščina (SL) (599.01 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
svenska (SV) (542.23 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Product information
Lusduna : EPAR - Product Information
English (EN) (2.63 MB - PDF)
First published: Last updated:
български (BG) (3.67 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
español (ES) (2.69 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
čeština (CS) (3.21 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
dansk (DA) (2.77 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Deutsch (DE) (2.73 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
eesti keel (ET) (2.66 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
ελληνικά (EL) (3.93 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
français (FR) (3.47 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
hrvatski (HR) (2.66 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
íslenska (IS) (2.64 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
italiano (IT) (2.74 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
latviešu valoda (LV) (5.57 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
lietuvių kalba (LT) (4.65 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
magyar (HU) (3.38 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Malti (MT) (3.6 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Nederlands (NL) (2.68 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
norsk (NO) (2.67 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
polski (PL) (3.47 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
português (PT) (2.77 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
română (RO) (2.79 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
slovenčina (SK) (3.68 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
slovenščina (SL) (3.26 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Suomi (FI) (2.87 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
svenska (SV) (2.63 MB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Latest procedure affecting product information:
T/0006
29/10/2018
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).
Lusduna : EPAR - All Authorised presentations
English (EN) (474.25 KB - PDF)
First published: Last updated:
български (BG) (493.44 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
español (ES) (474.32 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
čeština (CS) (486.35 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
dansk (DA) (476.25 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Deutsch (DE) (474.98 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
eesti keel (ET) (471.69 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
ελληνικά (EL) (493.75 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
français (FR) (473.02 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
hrvatski (HR) (479.21 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
íslenska (IS) (474.29 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
italiano (IT) (472.27 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
latviešu valoda (LV) (486.76 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
lietuvių kalba (LT) (473.9 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
magyar (HU) (487.07 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Malti (MT) (498 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Nederlands (NL) (923.74 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
norsk (NO) (475.82 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
polski (PL) (487.88 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
português (PT) (474.61 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
română (RO) (472.8 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
slovenčina (SK) (486.55 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
slovenščina (SL) (485.59 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Suomi (FI) (472.84 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
svenska (SV) (473.74 KB - PDF)
First published: 12/01/2017Last updated: 22/01/2019
Product details
- Name of medicine
- Lusduna
- Active substance
- insulin glargine
- International non-proprietary name (INN) or common name
- insulin glargine
- Therapeutic area (MeSH)
- Diabetes Mellitus
- Anatomical therapeutic chemical (ATC) code
- A10AE04
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Authorisation details
- EMA product number
- EMEA/H/C/004101
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
- Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands - Opinion adopted
- 09/11/2016
- Marketing authorisation issued
- 03/01/2017
- Revision
- 2
Assessment history
Lusduna : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (537.81 KB - PDF)
First published: Last updated:
Lusduna : EPAR - Public assessment report
AdoptedReference Number: EMA/813309/2016
English (EN) (3.71 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Lusduna
AdoptedReference Number: EMA/CHMP/706807/2016
English (EN) (525.48 KB - PDF)
First published: Last updated:
News on Lusduna
More information on Lusduna
Public statement on Lusduna: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/824401/2018
English (EN) (105.1 KB - PDF)
First published:
Related content
- Biosimilar medicines
- Clinical data (initial marketing authorisation)
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