United States - English - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide capsules are contraindicated in patients with a history of hypersensitivity reactions to: reactions to temozolomide capsules have included anaphylaxis [see adverse reactions (6.2)] . risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to temozolomide duri

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - temozolomide - glioma; glioblastoma - antineoplastic agents - for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (rt) and subsequently as monotherapy treatment.for the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

European Union - English - EMA (European Medicines Agency)

teva b.v.  - temozolomide - glioma; glioblastoma - antineoplastic agents - for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (rt) and subsequently as monotherapy treatment.for the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 5 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 20 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 100 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 140 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 180 mg - antineoplastic agents

Malta - English - Medicines Authority

fair-med healthcare gmbh planckstr. 13, 22765 hamburg, germany - temozolomide - hard capsule - temozolomide 250 mg - antineoplastic agents

Malta - English - Medicines Authority

hetero europe s.l. viladecans business park - edificio brasil catalunya 83-85 08840 viladecans, spain - temozolomide - hard capsule - temozolomide 100 mg - antineoplastic agents