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Pharmaceuticals - Union Register
Union Register of medicinal products for human use
|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|
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.
|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|