Overview
The marketing authorisation for Inpremzia has been withdrawn at the request of the marketing-authorisation holder.
Inpremzia : EPAR - Medicine overview
English (EN) (706.34 KB - PDF)
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italiano (IT) (694.38 KB - PDF)
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magyar (HU) (751.39 KB - PDF)
Malti (MT) (755.61 KB - PDF)
Nederlands (NL) (701.08 KB - PDF)
polski (PL) (755.89 KB - PDF)
português (PT) (699.33 KB - PDF)
română (RO) (716.07 KB - PDF)
slovenčina (SK) (751.22 KB - PDF)
slovenščina (SL) (747.71 KB - PDF)
Suomi (FI) (694.89 KB - PDF)
svenska (SV) (695.38 KB - PDF)
Inpremzia : EPAR - Risk management plan summary
English (EN) (718.91 KB - PDF)
Product information
Inpremzia : EPAR - Product Information
English (EN) (1.03 MB - PDF)
български (BG) (1.81 MB - PDF)
español (ES) (1.04 MB - PDF)
čeština (CS) (1.54 MB - PDF)
dansk (DA) (1.01 MB - PDF)
Deutsch (DE) (1.05 MB - PDF)
eesti keel (ET) (1.01 MB - PDF)
ελληνικά (EL) (1.85 MB - PDF)
français (FR) (1.03 MB - PDF)
hrvatski (HR) (1.06 MB - PDF)
íslenska (IS) (1.02 MB - PDF)
italiano (IT) (1.04 MB - PDF)
latviešu valoda (LV) (1.57 MB - PDF)
lietuvių kalba (LT) (1.08 MB - PDF)
magyar (HU) (1.58 MB - PDF)
Malti (MT) (1.61 MB - PDF)
Nederlands (NL) (1.05 MB - PDF)
norsk (NO) (1.02 MB - PDF)
polski (PL) (1.57 MB - PDF)
português (PT) (1.02 MB - PDF)
română (RO) (1.1 MB - PDF)
slovenčina (SK) (1.56 MB - PDF)
slovenščina (SL) (1.56 MB - PDF)
Suomi (FI) (1.02 MB - PDF)
svenska (SV) (1.02 MB - PDF)
04/04/2023
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).
Inpremzia : EPAR - All Authorised Presentations
English (EN) (616.14 KB - PDF)
български (BG) (641.03 KB - PDF)
español (ES) (611.68 KB - PDF)
čeština (CS) (630.55 KB - PDF)
dansk (DA) (617.03 KB - PDF)
Deutsch (DE) (613.74 KB - PDF)
eesti keel (ET) (609.79 KB - PDF)
ελληνικά (EL) (639.06 KB - PDF)
français (FR) (615.53 KB - PDF)
hrvatski (HR) (612.8 KB - PDF)
íslenska (IS) (613.28 KB - PDF)
italiano (IT) (610.05 KB - PDF)
latviešu valoda (LV) (632.83 KB - PDF)
lietuvių kalba (LT) (614.3 KB - PDF)
magyar (HU) (628.54 KB - PDF)
Malti (MT) (632.3 KB - PDF)
Nederlands (NL) (610.3 KB - PDF)
norsk (NO) (613.53 KB - PDF)
polski (PL) (631.12 KB - PDF)
português (PT) (611.83 KB - PDF)
română (RO) (614.43 KB - PDF)
slovenčina (SK) (634.14 KB - PDF)
slovenščina (SL) (628.79 KB - PDF)
Suomi (FI) (608.23 KB - PDF)
svenska (SV) (611.32 KB - PDF)
Product details
- Name of medicine
- Inpremzia
- Active substance
- insulin human (rDNA)
- International non-proprietary name (INN) or common name
- insulin human (rDNA)
- Therapeutic area (MeSH)
- Diabetes Mellitus
- Anatomical therapeutic chemical (ATC) code
- A10AB01
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
Inpremzia is indicated for the treatment of diabetes mellitus.
Authorisation details
- EMA product number
- EMEA/H/C/005331
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
- Baxter Holding B.V.
Baxter Holding B.V.
Kobaltweg 49
3542 CE
Utrecht
Netherlands - Opinion adopted
- 24/02/2022
- Marketing authorisation issued
- 25/04/2022
Assessment history
News on Inpremzia
Related content
Public statement on Inpremzia (insulin human (rDNA)) : Withdrawal of the marketing authorisation in the European Union
English (EN) (114.18 KB - PDF)