EU/3/11/849

About

On 15 April 2011, orphan designation (EU/3/11/849) was granted by the European Commission to AiCuris GmbH & Co. KG, Germany, for (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3, 4-dihydro-4-quinazolinyl} acetic acid for the prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at risk.

The sponsorship was transferred to Merck Sharp & Dohme Limited, United Kingdom, in March 2013.

(S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3, 4-dihydro-4-quinazolinyl} acetic acid has been authorised in the EU as Prevymis since 9 January 2018.

This medicine is now known as letermovir.

The sponsorship was transferred to Merck Europe B.V., The Netherlands, in June 2018.

Key facts

Active substance
(S)-{8-Fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3, 4-dihydro-4-quinazolinyl} acetic acid (letermovir)
Disease / condition
Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at...
Date of decision
15/04/2011
Outcome
Positive
Orphan decision number
EU/3/11/849

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Prevymis at the time of marketing authorisation and confirmed that the orphan designation should be maintained.

More information is available in the PDF iconorphan maintenance assessment report .

Sponsor's contact details

Merck Europe B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Tel: +31235153260
E-mail: orphan.information@merck.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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