EMA2026EN
Imatinib Teva — SmPC (Summary of Product Characteristics)
Zusammenfassung
## 1 1. NAME OF THE MEDICINAL PRODUCT
Imatinib Teva 100 mg film‑coated tablets
Imatinib Teva 400 mg film‑coated tablets
## 2 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Imatinib Teva 100 mg film‑coated tablets
Each film‑coated tablet contains 100 mg of imatinib (as mesilate).
Imatinib Teva 400 mg film‑coated tablets
Each film‑coated tablet contains 400 mg of imatinib (as mesilate).
For the full list of excipients, see section 6.1.
## 3 3. PHARMACEUTICAL FORM
Film‑coated tablet.
Kerninformationen
o equal doses.
Imatinib Teva 400 mg film‑coated tablets
Dark yellow to brownish orange oblong film‑coated tablets with a score line on one side. The tablet is debossed with “IT” and “4” at each side of the score line. The length of the film-coated tablet is approximately 20 mm and the width is ...
e or blast crisis.
adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.
adult patients with relapsed or refractory Ph+ ALL as monotherapy.
adult patients with myelodysplastic/myeloproliferative di...
al tumours (GIST).
the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
the treatment of adult patients with unresectable derma...
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