EMEA-001733-PIP02-15-M03 - paediatric investigation plan
gemtuzumab ozogamicin
PIPHuman
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Key facts
- Invented name
- Mylotarg
- Active substance
- gemtuzumab ozogamicin
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0314/2024
- PIP number
- EMEA-001733-PIP02-15-M03
- Pharmaceutical form(s)
- Powder for concentrate for solution for infusion
- Condition(s) / indication(s)
- Treatment of acute myeloid leukaemia
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Pfizer Europe MA EEIG
E-mail: medical.information@pfizer.com
Tel: +44 (0)1304 616161- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Nej