🇪🇺 Intrathecal pemetrexed in European Union

EMA authorised Intrathecal pemetrexed on 14 September 2015

Marketing authorisations

EMA — authorised 14 September 2015

  • Application: EMEA/H/C/004114
  • Marketing authorisation holder: Eli Lilly Netherlands
  • Local brand name: Pemetrexed Lilly
  • Indication: Malignant pleural mesothelioma Pemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Lilly 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 Lilly is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous
  • Status: withdrawn

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EMA — authorised 18 September 2015

  • Application: EMEA/H/C/004011
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Pemetrexed Sandoz
  • Indication: Malignant pleural mesothelioma Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Sandoz 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 Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squam
  • Status: withdrawn

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EMA — authorised 19 November 2015

  • Application: EMEA/H/C/003970
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Pemetrexed Pfizer (previously Pemetrexed Hospira)
  • Indication: Malignant pleural mesothelioma Pemetrexed Pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Pfizer 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 Pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squam
  • Status: approved

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EMA — authorised 26 November 2015

  • Application: EMEA/H/C/003905
  • Marketing authorisation holder: medac Gesellschaft für klinische Spezialpräparate mbH
  • Local brand name: Pemetrexed medac
  • Indication: Malignant pleural mesothelioma Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed medac 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 medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous
  • Status: approved

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EMA — authorised 2 December 2015

  • Application: EMEA/H/C/003788
  • Marketing authorisation holder: Menarini International Operations Luxembourg S.A.
  • Local brand name: Ciambra
  • Indication: Malignant pleural mesothelioma Ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Ciambra 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. Ciambra 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
  • Status: withdrawn

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EMA — authorised 18 January 2016

  • Application: EMEA/H/C/004072
  • Marketing authorisation holder: Accord Healthcare S.L.U.
  • Local brand name: Pemetrexed Accord
  • Indication: Malignant pleural mesothelioma Pemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Accord 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 Accord is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squam
  • Status: approved

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EMA — authorised 18 January 2016

  • Application: EMEA/H/C/004109
  • Marketing authorisation holder: Actavis Group PTC ehf
  • Local brand name: Armisarte (previously Pemetrexed Actavis)
  • Indication: Malignant pleural mesothelioma Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed 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 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
  • Status: approved

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EMA — authorised 22 July 2016

  • Application: EMEA/H/C/003895
  • Marketing authorisation holder: Fresenius Kabi Deutschland GmbH
  • Local brand name: Pemetrexed Fresenius Kabi
  • Indication: Malignant pleural mesothelioma Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancer Pemetrexed Fresenius Kabi 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 Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other
  • Status: approved

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EMA — authorised 14 October 2016

  • Application: EMEA/H/C/004306
  • Local brand name: Pemetrexed ditromethamine Hospira
  • Indication: Treatment of malignant pleural mesothelioma and non-small cell lung cancer
  • Status: withdrawn

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EMA — authorised 24 April 2017

  • Application: EMEA/H/C/004488
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited)
  • 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 metastati
  • Status: withdrawn

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EMA — authorised 22 May 2018

  • Application: EMEA/H/C/003958
  • Marketing authorisation holder: KRKA d.d.
  • Local brand name: Pemetrexed Krka
  • 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 ce
  • Status: withdrawn

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EMA — authorised 9 December 2022

  • Application: EMEA/H/C/005848
  • Marketing authorisation holder: Baxter Holding B.V.
  • Local brand name: Pemetrexed Baxter
  • Indication: Malignant pleural mesotheliomaPemetrexed Baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung cancerPemetrexed Baxter 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 section 5.1). Pemetrexed Baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than pre
  • Status: approved

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Frequently asked questions

Is Intrathecal pemetrexed approved in European Union?

Yes. EMA authorised it on 14 September 2015; EMA authorised it on 18 September 2015; EMA authorised it on 19 November 2015.

Who is the marketing authorisation holder for Intrathecal pemetrexed in European Union?

Eli Lilly Netherlands holds the EU marketing authorisation.