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Search results (28130)

PSUSA/00000491/202506 - periodic safety update report single assessment

Active substance(s) in scope of the PSUSA procedure: calcifediol

Procedure number: PSUSA/00000491/202506

Regulatory outcome: Maintenance

Last updated: 5 June 2026

PSUSAHuman

Zarzio

INN or common name:filgrastim

Therapeutic area (MeSH):Hematopoietic Stem Cell Transplantation; Cancer

Marketing authorisation issued: 6 February 2009

Last updated:5 June 2026

Revision: 27

Biosimilar

MedicineHumanAuthorised

Ixchiq

INN or common name:Chikungunya vaccine (live)

Therapeutic area (MeSH):Chikungunya virus

Marketing authorisation issued: 28 June 2024

Last updated:5 June 2026

Revision: 5

Additional monitoring

PRIME: priority medicine

MedicineHumanAuthorised

Ebymect

INN or common name:dapagliflozin; metformin

Therapeutic area (MeSH):Diabetes Mellitus, Type 2

Marketing authorisation issued: 15 November 2015

Last updated:5 June 2026

Revision: 25

MedicineHumanAuthorised

Xigduo

INN or common name:dapagliflozin; metformin

Therapeutic area (MeSH):Diabetes Mellitus, Type 2

Marketing authorisation issued: 16 January 2014

Last updated:5 June 2026

Revision: 27

MedicineHumanAuthorised

Dasselta

INN or common name:desloratadine

Therapeutic area (MeSH):Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Urticaria

Marketing authorisation issued: 28 November 2011

Last updated:5 June 2026

Revision: 14

Generic

MedicineHumanAuthorised

HyQvia

INN or common name:human normal immunoglobulin

Therapeutic area (MeSH):Immunologic Deficiency Syndromes; Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Marketing authorisation issued: 16 May 2013

Last updated:5 June 2026

Revision: 26

MedicineHumanAuthorised

CellCept

INN or common name:mycophenolate mofetil

Therapeutic area (MeSH):Graft Rejection

Marketing authorisation issued: 14 February 1996

Last updated:5 June 2026

Revision: 43

MedicineHumanAuthorised

Opsumit

INN or common name:macitentan

Therapeutic area (MeSH):Hypertension, Pulmonary

Marketing authorisation issued: 20 December 2013

Last updated:5 June 2026

Revision: 28

MedicineHumanAuthorised

Tivdak

INN or common name:tisotumab vedotin

Therapeutic area (MeSH):Uterine Cervical Neoplasms

Marketing authorisation issued: 28 March 2025

Last updated:5 June 2026

Revision: 4

Additional monitoring

MedicineHumanAuthorised

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Search results (28130)