Overview
The marketing authorisation for Busilvex has been withdrawn at the request of the marketing-authorisation holder.
Busilvex : EPAR - Summary for the public
English (EN) (632.03 KB - PDF)
български (BG) (727.28 KB - PDF)
español (ES) (632.08 KB - PDF)
čeština (CS) (706.23 KB - PDF)
dansk (DA) (653.89 KB - PDF)
Deutsch (DE) (632.95 KB - PDF)
eesti keel (ET) (630.25 KB - PDF)
ελληνικά (EL) (729.13 KB - PDF)
français (FR) (633.45 KB - PDF)
hrvatski (HR) (652.57 KB - PDF)
italiano (IT) (652.81 KB - PDF)
latviešu valoda (LV) (704.46 KB - PDF)
lietuvių kalba (LT) (657.75 KB - PDF)
magyar (HU) (699.44 KB - PDF)
Malti (MT) (708.29 KB - PDF)
Nederlands (NL) (632.68 KB - PDF)
polski (PL) (704.47 KB - PDF)
português (PT) (68.58 KB - PDF)
română (RO) (654.48 KB - PDF)
slovenčina (SK) (729.86 KB - PDF)
slovenščina (SL) (695.41 KB - PDF)
Suomi (FI) (631.13 KB - PDF)
svenska (SV) (634.02 KB - PDF)
Product information
Busilvex : EPAR - Product Information
English (EN) (1001.13 KB - PDF)
български (BG) (1.95 MB - PDF)
español (ES) (896.44 KB - PDF)
čeština (CS) (1.66 MB - PDF)
dansk (DA) (1008.12 KB - PDF)
Deutsch (DE) (1.02 MB - PDF)
eesti keel (ET) (972.62 KB - PDF)
ελληνικά (EL) (1.99 MB - PDF)
français (FR) (1023.19 KB - PDF)
hrvatski (HR) (1007.71 KB - PDF)
íslenska (IS) (937.3 KB - PDF)
italiano (IT) (978.84 KB - PDF)
latviešu valoda (LV) (1.57 MB - PDF)
lietuvių kalba (LT) (1016.01 KB - PDF)
magyar (HU) (1.53 MB - PDF)
Malti (MT) (1.6 MB - PDF)
Nederlands (NL) (887.39 KB - PDF)
norsk (NO) (890.3 KB - PDF)
polski (PL) (1.6 MB - PDF)
português (PT) (316.56 KB - PDF)
română (RO) (1010.13 KB - PDF)
slovenčina (SK) (1.55 MB - PDF)
slovenščina (SL) (1.55 MB - PDF)
Suomi (FI) (967.52 KB - PDF)
svenska (SV) (648.33 KB - PDF)
Latest procedure affecting product information: IAIN/0035/G
01/02/2022
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).
Product details
- Name of medicine
- Busilvex
- Active substance
- busulfan
- International non-proprietary name (INN) or common name
- busulfan
- Therapeutic area (MeSH)
- Hematopoietic Stem Cell Transplantation
- Anatomical therapeutic chemical (ATC) code
- L01AB01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.
Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Authorisation details
- EMA product number
- EMEA/H/C/000472
- Marketing authorisation holder
- Pierre Fabre Medicament
Les Cauquillous
81500 - Lavaur
France - Opinion adopted
- 19/03/2003
- Marketing authorisation issued
- 09/07/2003
- Revision
- 19
Assessment history
Busilvex : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (812.78 KB - PDF)
Busilvex-H-C-PSUSA-00000464-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
English (EN) (684.98 KB - PDF)
Busilvex-H-C-472-II-019 : EPAR - Assessment Report - Variation
English (EN) (3.76 MB - PDF)
CHMP post-authorisation summary of positive opinion for Busilvex
English (EN) (620.51 KB - PDF)
Busilvex-H-C-PSUSA-0464 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (622.72 KB - PDF)
Busilvex-H-C-472-A20-13 : EPAR - Assessment Report - Article 20
English (EN) (656.33 KB - PDF)
Busilvex-H-C-472-II-04 : EPAR - Scientific Discussion - Variation
English (EN) (741.22 KB - PDF)
News on Busilvex
Related content
This product is no longer an orphan medicine. It was originally designated an orphan medicine on 29 December 2001. Busilvex was withdrawn from the Community register of orphan medicinal products in July 2013 at the end of the 10-year period of market exclusivity
Final recommendations on 12 centrally authorised medicines manufactured at Ben Venue Laboratories
English (EN) (188.14 KB - PDF)
Questions and answers on shortcomings in quality assurance at Ben Venue Laboratories
English (EN) (71.91 KB - PDF)
More information on Busilvex
Public statement on Busilvex : Withdrawal of the marketing authorisation in the European Union
English (EN) (109.97 KB - PDF)