Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: PREVYMIS   
Auth. number : EU/1/17/1245
Active substance : letermovir
Orphan market exclusivity for "Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at risk" (based on designation EU/3/11/849) started on 10/01/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 10/01/2028
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AX - Other antivirals
Chemical substance: J05AX18 - letermovir
(See WHO ATC Index)
Indication: PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).

Consideration should be given to official guidance on the appropriate use of antiviral agents.
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/01/2018 Centralised - Authorisation EMEA/H/C/4536 (2018)108 of 8/01/2018
25/07/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4536/T/2 (2018)4977 of 23/07/2018
8/11/2018 Centralised - Variation EMEA/H/C/4536
21/03/2019 Centralised - Variation EMEA/H/C/4536/II/09