Spectrila (asparaginase)
- Region
- 🇪🇺 EU
- Active substance
- asparaginase
- Company
- Medac Gesellschaft fuer klinische Spezialpraeparate mbH
- Status
- Authorised
- Therapeutic area
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- EU approval
- Thu 14 Jan 2016
- Application
- EMEA/H/C/002661
- ATC
- L01XX02
- Official record
- www.ema.europa.eu
Indication
Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Graspa Application withdrawn · ERYTECH Pharma S.A.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.