EMA Monthly Medicines Under Evaluation Lists

Medicines for human use under evaluation

Each month, the European Medicines Agency's (EMA) publishes an updated list of medicines for human use currently under evaluation by EMA’s Committee for Medicinal Products for Human Use (CHMP) to obtain a marketing authorisation in the European Union (EU). Human Medicines

For information on treatments and vaccines for COVID-19, including those under evaluation by the CHMP:

• COVID-19 medicines The CHMP meets once per month. Its evaluations of marketing authorisation applications submitted through the centralised procedure provide the basis for authorisation of medicines in Europe.

Monthly lists of medicines under evaluation by the CHMP are available dating back to 2012. They contain the international non-proprietary names (INN), or common name for vaccines, and a brief summary of therapeutic indication. The INN contains only the active moiety for with no information on salt, ester or derivative. The lists are available in Excel format from February 2021 to support data sorting and filtering. From October 2025 three additional fields added: 'EMA prod. number', 'Is PRIME' and 'Is OPEN'.

The CHMP's independent recommendations on medicine for human use are based on a comprehensive scientific evaluation of data. For information on how EMA evaluates medicines and the CHMP's role in the authorisation of medicines in the EU:

• Authorisation of medicines
• Committee for Medicinal Products for Human Use (CHMP)

Monthly lists - 2026

As of March 2025, EMA publishes information in Excel format, on the start of the procedures for extension applications and for type II variations that propose an extension of the authorised indication handled in IRIS.

This information features in addition to the monthly lists of medicines under evaluation also available below.

It follows the transition of the post-authorisation regulatory procedures to IRIS. It is also in the context of the digitalisation of EMA's activities, and will help facilitate data analysis.

As of January 2025, monthly reports of applications for new human medicines undergoing evaluation by the CHMP include:

• a summary of the therapeutic indication applied for by the applicant;
• date of re-start of the procedure, following submission of responses to the list of questions (at day 121 or at day 91 for applications under accelerated assessment, non-advanced therapy medicinal products (ATMPs)). Applications for new human medicines under evaluation: April 2026

Reference Number: EMA/80934/2026 English (EN) (104.78 KB - XLSX)

First published:

14/04/2026

View Start of procedure: Extension of marketing authorisation (27 February 2026 - 26 March 2026)

Reference Number: EMA/76189/2026 English (EN) (96.41 KB - XLSX)

First published:

01/04/2026

View Applications for new human medicines under evaluation: March 2026

Reference Number: EMA/53995/2026 English (EN) (105.66 KB - XLSX)

First published:

11/03/2026

View Start of procedure: Extension of marketing authorisation (30 January 2026 - 26 February 2026)

Reference Number: EMA/50188/2026 English (EN) (96.3 KB - XLSX)

First published:

03/03/2026

View Applications for new human medicines under evaluation: February 2026

Reference Number: EMA/EMA/28614/2026 English (EN) (105.68 KB - XLSX)

First published:

05/02/2026

View Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (12 December 2025 - 29 January 2026)

Reference Number: EMA/27039/2026 English (EN) (106.82 KB - XLSX)

First published:

04/02/2026

View Start of procedure: Extension of marketing authorisation (12 December 2025 - 29 January 2026)

Reference Number: EMA/27038/2026 English (EN) (96.64 KB - XLSX)

First published:

04/02/2026

View Applications for new human medicines under evaluation: January 2026

Reference Number: EMA/11494/2026 English (EN) (105.11 KB - XLSX)

First published:

20/01/2026

View

Monthly lists - 2025

Start of procedure: Extension of marketing authorisation (14 November - 11 December 2025)

Reference Number: EMA/392654/2025 English (EN) (95.69 KB - XLSX)

First published:

16/12/2025

View Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (14 November - 11 December 2025)

Reference Number: EMA/392653/2025 English (EN) (99.71 KB - XLSX)

First published:

16/12/2025

View Applications for new human medicines under evaluation: December 2025

Reference Number: EMA/352289/2025 English (EN) (104.06 KB - XLSX)

First published:

05/12/2025

View Start of procedure: Extension of marketing authorisation (17 October - 13 November 2025)

Reference Number: EMA/365076/2025 English (EN) (96.81 KB - XLSX)

First published:

18/11/2025

View Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (17 October - 13 November 2025)

Reference Number: EMA/365051/2025 English (EN) (99.5 KB - XLSX)

First published:

18/11/2025

View Applications for new human medicines under evaluation: November 2025

Reference Number: EMA/352289/2025 English (EN) (104.45 KB - XLSX)

First published:

05/11/2025

View Start of procedure: Extension of marketing authorisation (19 September - 16 October 2025)

Reference Number: EMA/337105/2025 English (EN) (96.35 KB - XLSX)

First published:

22/10/2025

View Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (19 September - 16 October 2025)

Reference Number: EMA/337148/2025 English (EN) (95.81 KB - XLSX)

First published:

22/10/2025

View Applications for new human medicines under evaluation: October 2025

Reference Number: EMA/322049/2025 English (EN) (105.25 KB - XLSX)

First published:

10/10/2025

View Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (22 August 2025 - 18 September 2025)

Reference Number: EMA/307982/2025 English (EN) (100.45 KB - XLSX)

First published:

23/09/2025

View Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (25 July - 21 August 2025)

Reference Number: EMA/286994/2025 English (EN) (105.86 KB - XLSX)

First published:

08/09/2025

View Start of procedure: Extension of marketing authorisation (25 July - 21 August 2025)

Reference Number: EMA/286995/2025 English (EN) (103.27 KB - XLSX)

First published:

08/09/2025

View Applications for new human medicines under evaluation: September 2025

Reference Number: EMA/283011/2025 English (EN) (103.96 KB - XLSX)

First published:

01/09/2025

View Applications for new human medicines under evaluation: August 2025

Reference Number: EMA/258764/2025 English (EN) (103.27 KB - XLSX)

First published:

07/08/2025

View Start of procedure: Extension of marketing authorisation (20 June 2025 - 24 July 2025)

Reference Number: EMA/244908/2025 English (EN) (102.79 KB - XLSX)

First published:

28/07/2025

View Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (20 June 2025 - 24 July 2025)

Reference Number: EMA/244915/2025 English (EN) (108.37 KB - XLSX)

First published:

28/07/2025

View Applications for new human medicines under evaluation: July 2025

Reference Number: EMA/134672/2025 English (EN) (103.79 KB - XLSX)

First published:

18/07/2025

View Applications for new human medicines under evaluation: June 2025

Reference Number: EMA/187336/2025 English (EN) (102.62 KB - XLSX)

First published:

12/06/2025

View Start of procedure: Type II variation - extension of indication (26 April - 22 May 2025)

Reference Number: EMA/179155/2025 English (EN) (109.28 KB - XLSX)

First published:

27/05/2025

View Start of procedure - extension of marketing authorisation (26 April - 22 May 2025)

Reference Number: EMA/179147/2025 English (EN) (104.25 KB - XLSX)

First published:

27/05/2025

View Applications for new human medicines under evaluation: May 2025

Reference Number: EMA/153582/2025 English (EN) (103.5 KB - XLSX)

First published:

13/05/2025

View Applications for new human medicines under evaluation: April 2025

Reference Number: EMA/124951/2025 English (EN) (104.21 KB - XLSX)

First published:

16/04/2025

View Start of procedure: Type II variation - extension of indication under evaluation by the CHMP (28 February 2025 - 27 March 2025)

Reference Number: EMA/112150/2025 English (EN) (107.61 KB - XLSX)

First published:

01/04/2025

View Start of procedure: Extension of marketing authorisation (28 February 2025 - 27 March 2025)

Reference Number: EMA/112158/2025 English (EN) (104.42 KB - XLSX)

First published:

01/04/2025

View Applications for new human medicines under evaluation: March 2025

Reference Number: EMA/83261/2025 English (EN) (103.93 KB - XLSX)

First published:

14/03/2025

View Start of procedure: Type II variation - extension of indication under evaluation by the CHMP (31 January - 27 February 2025)

Reference Number: EMA/78066/2025 English (EN) (106.91 KB - XLSX)

First published:

04/03/2025

View Start of procedure: Extension of marketing authorisation (31 January - 27 February 2025)

Reference Number: EMA/78061/2025 English (EN) (106.5 KB - XLSX)

First published:

04/03/2025

View Applications for new human medicines under evaluation: February 2025

Reference Number: EMA/51244/2025 English (EN) (103.65 KB - XLSX)

First published:

10/02/2025

View Applications for new human medicines under evaluation: January 2025

Reference Number: EMA/5196/2025 English (EN) (103.64 KB - XLSX)

First published:

16/01/2025

View

Monthly lists - 2024

Applications for new human medicines under evaluation: December 2024

Adopted Reference Number: EMA/561462/2024 English (EN) (98.85 KB - XLSX)

First published:

09/12/2024

View Applications for new human medicines under evaluation: November 2024

Reference Number: EMA/512631/2024 English (EN) (99.08 KB - XLSX)

First published:

07/11/2024

View Applications for new human medicines under evaluation: October 2024

Reference Number: EMA/459172/2024 English (EN) (99.35 KB - XLSX)

First published:

08/10/2024

View Applications for new human medicines under evaluation: September 2024

Reference Number: EMA/414559/2024 English (EN) (99.58 KB - XLSX)

First published:

06/09/2024

View Applications for new human medicines under evaluation: August 2024

Reference Number: EMA/368078/2024 English (EN) (99.21 KB - XLSX)

First published:

12/08/2024

View Applications for new human medicines under evaluation: July 2024

Reference Number: EMA/320819/2024 English (EN) (774.32 KB - XLSX)

First published:

15/07/2024

View Applications for new human medicines under evaluation: June 2024

Reference Number: EMA/273906/2024 English (EN) (99.28 KB - XLSX)

First published:

14/06/2024

View Applications for new human medicines under evaluation: May 2024

Reference Number: EMA/2018069/2024 English (EN) (816.88 KB - XLSX)

First published:

07/05/2024

View Applications for new human medicines under evaluation: April 2024

Reference Number: EMA/140936/2024 English (EN) (99.53 KB - XLSX)

First published:

12/04/2024

View Applications for new human medicines under evaluation: March 2024

Reference Number: EMA/97964/2024 English (EN) (99.39 KB - XLSX)

First published:

12/03/2024

View Applications for new human medicines under evaluation: February 2024

Reference Number: EMA/58689/2024 English (EN) (99.49 KB - XLSX)

First published:

12/02/2024

View Applications for new human medicines under evaluation: January 2024

Reference Number: EMA/9538/2024 Corr. English (EN) (563.08 KB - XLSX)

First published:

15/01/2024

Last updated:

26/01/2024

View

Monthly lists - 2023

Applications for new human medicines under evaluation by the CHMP: December 2023

Reference Number: EMA/553110/2023 English (EN) (99.08 KB - XLSX)

First published:

07/12/2023

View Applications for new human medicines under evaluation by the CHMP: November 2023

Reference Number: EMA/989140/2023 English (EN) (99.01 KB - XLSX)

First published:

07/11/2023

View Applications for new human medicines under evaluation by the CHMP: October 2023

Reference Number: EMA/444135/2023 English (EN) (99.06 KB - XLSX)

First published:

06/10/2023

View Applications for new human medicines under evaluation by the CHMP: September 2023

Reference Number: EMA/401841/2023 English (EN) (99.03 KB - XLSX)

First published:

07/09/2023

View Applications for new human medicines under evaluation by the CHMP: August 2023

Reference Number: EMA/350192/2023 English (EN) (99.85 KB - XLSX)

First published:

14/08/2023

View Applications for new human medicines under evaluation by the CHMP: July 2023

Reference Number: EMA/309551/2023 English (EN) (98.86 KB - XLSX)

First published:

17/07/2023

View Applications for new human medicines under evaluation by the CHMP: June 2023

Reference Number: EMA/207108/2023 English (EN) (98.76 KB - XLSX)

First published:

09/06/2023

Last updated:

07/07/2023

View Applications for new human medicines under evaluation by the CHMP: May 2023

Reference Number: EMA/207107/2023 English (EN) (98.47 KB - XLSX)

First published:

10/05/2023

View Applications for new human medicines under evaluation by the CHMP: April 2023

Reference Number: EMA/164278/2023 English (EN) (98.65 KB - XLSX)

First published:

14/04/2023

View Applications for new human medicines under evaluation by the CHMP: March 2023

Reference Number: EMA/104578/2023 English (EN) (98.73 KB - XLSX)

First published:

09/03/2023

View Applications for new human medicines under evaluation by the CHMP: February 2023

Reference Number: EMA/58424/2023 corr English (EN) (99.09 KB - XLSX)

First published:

10/02/2023

Last updated:

14/02/2023

View Applications for new human medicines under evaluation by the CHMP: January 2023

Reference Number: EMA/13171/2023 English (EN) (98.73 KB - XLSX)

First published:

12/01/2023

View

Monthly lists - 2022

Applications for new human medicines under evaluation by the CHMP: December 2022

Reference Number: EMA/932370/2022 English (EN) (98.77 KB - XLSX)

First published:

12/12/2022

View Applications for new human medicines under evaluation by the CHMP: November 2022

Reference Number: EMA/855051/2022 English (EN) (109.4 KB - XLSX)

First published:

03/11/2022

View Applications for new human medicines under evaluation by the CHMP: October 2022

Reference Number: EMA/822461/2022 English (EN) (110.58 KB - XLSX)

First published:

13/10/2022

View Applications for new human medicines under evaluation by the CHMP: September 2022

Reference Number: EMA/784941/2022 English (EN) (111 KB - XLSX)

First published:

27/09/2022

View Applications for new human medicines under evaluation by the CHMP: August 2022

Reference Number: EMA/685123/2022 English (EN) (98.16 KB - XLSX)

First published:

10/08/2022

View Applications for new human medicines under evaluation by the CHMP: July 2022

Reference Number: EMA/623957/2022 English (EN) (110.1 KB - XLSX)

First published:

08/07/2022

View Applications for new human medicines under evaluation by the CHMP: June 2022

Reference Number: EMA/564600/2022 English (EN) (98.61 KB - XLSX)

First published:

08/06/2022

View Applications for new human medicines under evaluation by the CHMP: May 2022

English (EN) (98.68 KB - XLSX)

First published:

16/05/2022

View Applications for new human medicines under evaluation by the CHMP: April 2022

Reference Number: EMA/203848/2022 English (EN) (98.89 KB - XLSX)

First published:

08/04/2022

View Applications for new human medicines under evaluation by the CHMP: March 2022

Reference Number: EMA/144373/2022 Corr. English (EN) (99.24 KB - XLSX)

First published:

11/03/2022

Last updated:

23/03/2022

View Applications for new human medicines under evaluation by the CHMP: February 2022

Reference Number: EMA/71693/2022 Corr. English (EN) (100.15 KB - XLSX)

First published:

04/02/2022

Last updated:

23/03/2022

View Applications for new human medicines under evaluation by the CHMP: January 2022

Reference Number: EMA/4718/2022 English (EN) (99.26 KB - XLSX)

First published:

07/01/2022

View

Monthly lists - 2021

Applications for new human medicines under evaluation by the CHMP: December 2021

Reference Number: EMA/726376/2021 English (EN) (99.69 KB - XLSX)

First published:

08/12/2021

View Applications for new human medicines under evaluation by the CHMP: November 2021

Reference Number: EMA/625035/2021 English (EN) (775.78 KB - XLSX)

First published:

08/11/2021

View Applications for new human medicines under evaluation by the CHMP: October 2021

Reference Number: EMA/569084/2021 English (EN) (99.12 KB - XLSX)

First published:

08/10/2021

View Applications for new human medicines under evaluation by the CHMP: September 2021

Reference Number: EMA/491283/2021 English (EN) (99.19 KB - XLSX)

First published:

02/09/2021

View Applications for new human medicines under evaluation by the CHMP: August 2021

Reference Number: EMA/444323/2021 English (EN) (98.77 KB - XLSX)

First published:

09/08/2021

View Applications for new human medicines under evaluation by the CHMP: July 2021

Reference Number: EMA/373584/2021 English (EN) (98.69 KB - XLSX)

First published:

09/07/2021

View Applications for new human medicines under evaluation by the CHMP: June 2021

Reference Number: EMA/316655/2021 English (EN) (98.72 KB - XLSX)

First published:

07/06/2021

View Applications for new human medicines under evaluation by the CHMP: May 2021

Reference Number: EMA/247078/2021 English (EN) (98.71 KB - XLSX)

First published:

17/05/2021

View Applications for new human medicines under evaluation by the CHMP: April 2021

Reference Number: EMA/201519/2021 English (EN) (98.27 KB - XLSX)

First published:

26/04/2021

View Applications for new human medicines under evaluation by the CHMP: March 2021

Reference Number: EMA/151574/2021 English (EN) (98.09 KB - XLSX)

First published:

12/03/2021

View Applications for new human medicines under evaluation by the CHMP: February 2021

Reference Number: EMA/75461/2021 English (EN) (97.28 KB - XLSX)

First published:

10/02/2021

View Applications for new human medicines under evaluation by the CHMP: January 2021

Reference Number: EMA/1722/2021 English (EN) (104.11 KB - PDF)

First published:

11/01/2021

View

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