Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited) (pemetrexed)
- Region
- 🇪🇺 EU
- Active substance
- pemetrexed
- Company
- Pfizer Europe MA EEIG
- Status
- Withdrawn
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung; Mesothelioma
- CHMP opinion
- Thu 23 Feb 2017
- EU approval
- Mon 24 Apr 2017
- Designations
- Generic
- Application
- EMEA/H/C/004488
- ATC
- L01BA04
- Official record
- www.ema.europa.eu
Indication
Malignant pleural mesothelioma Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Hospira UK Limited in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see SmPC section 5.1). Pemetrexed Hospira UK Limited is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see SmPC section 5.1). Pemetrexed Hospira UK Limited is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see SmPC section 5.1).
Regulatory milestones
No milestones recorded in the last year.
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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.