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Parliamentary questions
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15 January 2018
Question for written answer E-000208-18
to the Commission
Rule 130
Soledad Cabezón Ruiz (S&D)

 Subject:  Evaluation of Aplidin
 Answer in writing 

A question for a written answer (P‐007464/2017) was tabled to the Commission in December 2017, concerning the marketing authorisation procedure for Aplidin as a medicinal product for multiple myeloma. The application for marketing authorisation was filed by the pharmaceutical firm PharmaMar.

The Commission gave its answer in January 2018. However it is still not clear why, despite two verbal submissions and favourable reports by the rapporteur and co-rapporteur, the final decision by the CHMP was negative.

There is now a period of 60 days during which PharmaMar may submit its grounds for a re‐examination. It should be noted in this respect that the Myeloma Patients Europe association is also particularly interested in knowing where the procedure now stands.

Furthermore, PharmaMar now has a licence in Israel for the molecule concerned.

1. Are the EMA and the Commission aware that the molecule has been licensed in Israel?

2. What are the main grounds for the EMA’s refusal to authorise use of Aplidin in the EU?

3. What are the differences between Israel and the EU?

Original language of question: ES 
Last updated: 5 February 2018Legal notice