Pemetrexed Krka (pemetrexed)
- Region
- 🇪🇺 EU
- Active substance
- pemetrexed
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Withdrawn
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung; Mesothelioma
- CHMP opinion
- Thu 22 Mar 2018
- EU approval
- Tue 22 May 2018
- Designations
- Generic
- Application
- EMEA/H/C/003958
- ATC
- L01BA04
- Official record
- www.ema.europa.eu
Indication
Malignant pleural mesothelioma Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Krka 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. Pemetrexed Krka 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. Pemetrexed Krka 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Pemetrexed medac Withdrawn · medac Gesellschaft für klinische Spezialpräparate mbH
- 🇪🇺 Pemetrexed Baxter Withdrawn · Baxter Holding B.V.
- 🇪🇺 Alimta Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Pemetrexed Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Pemetrexed Pfizer (previously Pemetrexed Hospira) Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Armisarte (previously Pemetrexed Actavis) Authorised · Actavis Group PTC ehf
- 🇪🇺 Pemetrexed Fresenius Kabi Authorised · Fresenius Kabi Deutschland GmbH
- 🇪🇺 Pemetrexed Sandoz Withdrawn · Sandoz GmbH
- 🇪🇺 Ciambra Withdrawn · Menarini International Operations Luxembourg S.A.
- 🇪🇺 Pemetrexed Lilly Withdrawn · Eli Lilly Netherlands
- 🇪🇺 Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited) Withdrawn · Pfizer Europe MA EEIG
- 🇪🇺 Pemetrexed ditromethamine Hospira Application withdrawn ·
Follow Pemetrexed Krka
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.