Full Press Release Details
DECISION OF THE COMMITTEE
the designation of the "Rintatolimod" medicinal product as an orphan medicinal product under (EC) Regulation No 141/2000
of the European Parliament and of the Council
relevant to the EEA)
TEXT IN THE DUTCH LANGUAGE SHALL BE CONSIDERED AS AUTHENTIC)
DECISION OF THE COMMITTEE
the designation of the "Rintatolimod" medicinal product as an orphan medicinal product under (EC) Regulation No 141/2000
of the European Parliament and of the Council
relevant to the EEA)
TEXT IN THE DUTCH LANGUAGE SHALL BE CONSIDERED AS AUTHENTIC)
consideration of the Treaty on the activities of the European Union,
consideration of the (EC) Regulation No 141/2000 of the European Parliament and of the Council of 16DEC1999 on orphan medicinal
products 1 and in particular the first sentence of Article 5(8) thereof,
consideration of the application submitted on 22SEP2020 by Hemispherx Biopharma Europe in accordance with Article 5(1) of (EC)
Regulation No 141/2000,
consideration of the favorable opinion from the European Medicines Agency issued by the Committee for Orphan Medicinal Products
on 21JAN2021 received by the Committee on 27JAN2021,
consideration of the following:
| (1) | The application submitted by Hemispherx Biopharma Europe for the "Rintatolimod" medicinal product was declared valid on 26OCT2020 in accordance with Article 5(4) of the (EC) Regulation No 141/2000. |
| (2) | The "Rintatolimod" medicinal product meets the designation criteria in accordance with Article 3(1) of the (EC) Regulation No 141/2000. |
| (3) | The application should therefore be accepted, |
ADOPTED THE FOLLOWING DECISION:
"Rintatolimod" medicinal product is designated as an orphan medicinal product for the following indication: Treatment
of pancreatic cancer. It is entered in the Community Register of Orphan Medicinal Products under the following number EU/3/21/2403.
European Medicines Agency shall make the opinion of the Committee for Orphan Medicinal Products covered by this decision available
to all the interested parties.
L 18 of 22JAN2000, page 1.
decision is addressed to Hemispherx Biopharma Europe, Leopold De Vriesstraat 26, 2600 Berchem, Antwerp, Belgium.
in Brussels, 19FEB2021