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Gardasil

INN or common name: human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Therapeutic area (MeSH): Papillomavirus Infections; Uterine Cervical Dysplasia; Condylomata Acuminata; Immunization

Marketing authorisation issued: 20 September 2006

Last updated: 20 October 2025

Revision: 52

Medicine Human Authorised

Herwenda

INN or common name: trastuzumab

Therapeutic area (MeSH): Breast Neoplasms; Stomach Neoplasms

Marketing authorisation issued: 15 November 2023

Last updated: 20 October 2025

Revision: 2

Additional monitoring

Biosimilar

Medicine Human Authorised

MiPet Easecto

INN or common name: sarolaner

Last updated: 20 October 2025

Medicine Veterinary Withdrawn

Tremfya

INN or common name: guselkumab

Therapeutic area (MeSH): Psoriasis; Crohn Disease; Colitis, Ulcerative

Marketing authorisation issued: 10 November 2017

Last updated: 20 October 2025

Revision: 13

Medicine Human Authorised

Elevidys

INN or common name: delandistrogene moxeparvovec

Therapeutic area (MeSH): Muscular Dystrophy, Duchenne

Refusal of marketing authorisation: 24 September 2025

Last updated: 20 October 2025

Advanced therapy

Orphan

Medicine Human Refused

Vueway

INN or common name: gadopiclenol

Therapeutic area (MeSH): Magnetic Resonance Imaging

Marketing authorisation issued: 7 December 2023

Last updated: 20 October 2025

Revision: 3

Additional monitoring

Medicine Human Authorised

Imvanex

INN or common name: smallpox and monkeypox vaccine (Live Modified Vaccinia Virus Ankara)

Therapeutic area (MeSH): Smallpox Vaccine; Monkeypox virus

Marketing authorisation issued: 31 July 2013

Last updated: 20 October 2025

Revision: 31

Additional monitoring

Exceptional circumstances

Medicine Human Authorised

Crysvita - direct healthcare professional communication (DHPC)

Active substance: burosumab

DHPC type: Adverse event

Last updated: 20 October 2025

DHPC Veterinary

Pluvicto

INN or common name: lutetium (177Lu) vipivotide tetraxetan

Therapeutic area (MeSH): Prostatic Neoplasms, Castration-Resistant

Marketing authorisation issued: 9 December 2022

Last updated: 20 October 2025

Revision: 11

Additional monitoring

Medicine Human Authorised

Herceptin

INN or common name: trastuzumab

Therapeutic area (MeSH): Stomach Neoplasms; Breast Neoplasms

Marketing authorisation issued: 28 August 2000

Last updated: 20 October 2025

Revision: 45

Medicine Human Authorised

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