Human medicines European public assessment report (EPAR): Ivozall, clofarabine, Date of authorisation: 14/11/2019, Revision: 5, Status: Withdrawn
Overview
Ivozall : EPAR - Medicine overview
First published: Last updated: Reference Number: EMA/519636/2019
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čeština (CS) (202.08 KB - PDF)
dansk (DA) (161.04 KB - PDF)
Deutsch (DE) (168.12 KB - PDF)
eesti keel (ET) (154.3 KB - PDF)
ελληνικά (EL) (229.12 KB - PDF)
français (FR) (166.85 KB - PDF)
hrvatski (HR) (185.94 KB - PDF)
italiano (IT) (162.29 KB - PDF)
latviešu valoda (LV) (202.84 KB - PDF)
lietuvių kaiba (LT) (192.05 KB - PDF)
magyar (HU) (190.88 KB - PDF)
Malti (MT) (203.71 KB - PDF)
Nederlands (NL) (167.6 KB - PDF)
polski (PL) (198 KB - PDF)
português (PT) (164.09 KB - PDF)
română (RO) (206.05 KB - PDF)
slovenčina (SK) (190.95 KB - PDF)
slovenščina (SL) (186.41 KB - PDF)
Suomi (FI) (157.35 KB - PDF)
svenska (SV) (160.74 KB - PDF)
Ivozall : EPAR - Risk-management-plan summary
First published: Last updated:
Product information
Ivozall : EPAR - Product Information
First published: Last updated:
български (BG) (1.93 MB - PDF)
español (ES) (1.6 MB - PDF)
čeština (CS) (1.6 MB - PDF)
dansk (DA) (1.39 MB - PDF)
Deutsch (DE) (1.63 MB - PDF)
eesti keel (ET) (1.38 MB - PDF)
ελληνικά (EL) (2.05 MB - PDF)
français (FR) (1.53 MB - PDF)
hrvatski (HR) (1.64 MB - PDF)
islandsk (IS) (1.45 MB - PDF)
italiano (IT) (1.49 MB - PDF)
latviešu valoda (LV) (1.78 MB - PDF)
lietuvių kaiba (LT) (1.77 MB - PDF)
magyar (HU) (1.65 MB - PDF)
Malti (MT) (1.91 MB - PDF)
Nederlands (NL) (1.5 MB - PDF)
norsk (NO) (1.37 MB - PDF)
polski (PL) (1.85 MB - PDF)
português (PT) (1.51 MB - PDF)
română (RO) (1.93 MB - PDF)
slovenčina (SK) (1.75 MB - PDF)
slovenščina (SL) (1.65 MB - PDF)
Suomi (FI) (1.42 MB - PDF)
svenska (SV) (1.46 MB - PDF)
Latest procedure affecting product information: IB/0006
06/03/2023
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).
Ivozall : EPAR - All authorised presentations
First published: Last updated:
български (BG) (68.66 KB - PDF)
español (ES) (43.68 KB - PDF)
čeština (CS) (60.53 KB - PDF)
dansk (DA) (42.01 KB - PDF)
Deutsch (DE) (42.28 KB - PDF)
eesti keel (ET) (42.25 KB - PDF)
ελληνικά (EL) (67.88 KB - PDF)
français (FR) (42.42 KB - PDF)
hrvatski (HR) (58.09 KB - PDF)
islandsk (IS) (48.21 KB - PDF)
italiano (IT) (42.35 KB - PDF)
latviešu valoda (LV) (63.12 KB - PDF)
lietuvių kaiba (LT) (58.29 KB - PDF)
magyar (HU) (50.57 KB - PDF)
Malti (MT) (62.56 KB - PDF)
Nederlands (NL) (41.67 KB - PDF)
norsk (NO) (44.81 KB - PDF)
polski (PL) (60.33 KB - PDF)
português (PT) (42.7 KB - PDF)
română (RO) (63.09 KB - PDF)
slovenčina (SK) (58.86 KB - PDF)
slovenščina (SL) (51.31 KB - PDF)
Suomi (FI) (41.19 KB - PDF)
svenska (SV) (42.52 KB - PDF)
Product details
- Name of medicine
Ivozall
- Active substance
clofarabine
- International proprietary name (INN) or common name
clofarabine
- Therapeutic area (MeSH)
Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Anatomical therapeutic chemical (ATC) code
L01BB06
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis.
Authorisation details
- EMA product number
EMEA/H/C/005039
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
- ORPHELIA Pharma SAS
85 Boulevard Saint-Michel
75005 Paris
France - Opinion adopted
19/09/2019
- Marketing authorisation issued
14/11/2019
- Revision
5
Assessment history
Ivozall : EPAR - Procedural steps taken and scientific information after authorisation
First published: Last updated:
Ivozall-H-C-PSUSA-00000805-201912 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
AdoptedFirst published: Last updated: Reference Number: EMA/517911/2020
Ivozall : EPAR - Public assessment report
AdoptedFirst published: Last updated: Reference Number: EMA/CHMP/585665/2019
CHMP summary of positive opinion for Ivozall
AdoptedFirst published: Last updated: Reference Number: EMA/CHMP/494372/2019
More information on Ivozall
Questions and answers on generic medicines
First published: Last updated: Reference Number: EMA/393905/2006 Rev. 2
български (BG) (93.16 KB - PDF)
español (ES) (68.3 KB - PDF)
čeština (CS) (87.71 KB - PDF)
dansk (DA) (66.79 KB - PDF)
Deutsch (DE) (67.55 KB - PDF)
eesti keel (ET) (65.21 KB - PDF)
ελληνικά (EL) (91.29 KB - PDF)
français (FR) (68.35 KB - PDF)
hrvatski (HR) (87.8 KB - PDF)
italiano (IT) (67.62 KB - PDF)
latviešu valoda (LV) (111.81 KB - PDF)
lietuvių kaiba (LT) (86.76 KB - PDF)
magyar (HU) (85.76 KB - PDF)
Malti (MT) (89.35 KB - PDF)
Nederlands (NL) (66.81 KB - PDF)
polski (PL) (88.51 KB - PDF)
português (PT) (68.32 KB - PDF)
română (RO) (86.9 KB - PDF)
slovenčina (SK) (87.73 KB - PDF)
slovenščina (SL) (84.8 KB - PDF)
Suomi (FI) (66.21 KB - PDF)
svenska (SV) (67.11 KB - PDF)
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