💊 Osservatorio Regolatorio Pharma

Regulatory intelligence quotidiana e gratuita

Pubblicazioni dal 26/08/2026 06:25 a ora — 36 news

AIFA (1)

Notifica dei provvedimenti - Ufficio Ispezioni e Autorizzazioni GMP Medicinali
Modalità di notifica dei documenti prodotti dall’Ufficio Ispezioni e Autorizzazioni GMP Medicinali (prodotti in formato cartaceo e prodotti in formato elettronico e firmati digitalmente).
Apri →

EMA – What's new (22)

List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs)
Apri →
Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Date of authorisation: 26/03/2021, Revision: 10, Status: Authorised
Apri →
Veterinary medicines European public assessment report (EPAR): Nobivac NXT FeLV, feline leukemia (self-amplifying RNA particle) vaccine, Status: Authorised
Apri →
Veterinary medicines European public assessment report (EPAR): Nobivac NXT HCPFeLV, feline calicivirosis, feline rhinotracheitis, feline panleucopenia and feline leukemia (self-amplifying RNA particle) vaccine, Status: Authorised
Apri →
Human medicines European public assessment report (EPAR): Wegovy, semaglutide, Date of authorisation: 06/01/2022, Revision: 18, Status: Authorised
Apri →
Committee for Advanced Therapies (CAT): 17-19 June 2026, European Medicines Agency, Amsterdam, the Netherlands, from 17 June 2026 to 19 June 2026
Apri →
Minutes of the CAT meeting 17-19 June 2026
Apri →
Committee for Advanced Therapies (CAT): 11-13 May 2026, European Medicines Agency, Amsterdam, the Netherlands, from 11 May 2026 to 13 May 2026
Apri →
Minutes of the CAT meeting 11-13 May 2026
Apri →
QRD guidance on the use of adopted abbreviations and pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national procedures
Apri →
Medicines for human use under evaluation
Apri →
Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (24 July 2026 - 20 August 2026)
Apri →
Start of procedure: Extension of marketing authorisation (24 July 2026 - 20 August 2026)
Apri →
Orphan designation: daratumumab Treatment of AL amyloidosis, 25/05/2018 Withdrawn
Apri →
Human medicines European public assessment report (EPAR): Darzalex, daratumumab, Date of authorisation: 20/05/2016, Revision: 30, Status: Authorised
Apri →
Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Date of authorisation: 16/03/2016, Revision: 16, Status: Authorised
Apri →
Human medicines European public assessment report (EPAR): Skyrizi, risankizumab, Date of authorisation: 26/04/2019, Revision: 31, Status: Authorised
Apri →
List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment
Apri →
Human medicines European public assessment report (EPAR): Blenrep, belantamab mafodotin, Date of authorisation: 23/07/2025, Revision: 3, Status: Authorised
Apri →
Human medicines European public assessment report (EPAR): Bysumlog, insulin lispro, Date of authorisation: 06/05/2026, Revision: 1, Status: Authorised
Apri →
Human medicines European public assessment report (EPAR): Tezspire, tezepelumab, Date of authorisation: 19/09/2022, Revision: 15, Status: Authorised
Apri →
Human medicines European public assessment report (EPAR): Vijoice, alpelisib, Date of authorisation: 15/07/2026, Status: Authorised
Apri →

EU Union Register of Medicinal Products (12)

EU/3/26/3277 (H. Lundbeck A/S)
EU/3/26/3277 (Active substance: Asedebart) - Orphan designation - Commission Decision (2026) 5999 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000332804
Apri →
EU/3/26/3286 (Parexel International (IRL) Limited)
EU/3/26/3286 (Active substance: Humanised IgG4 monoclonal antibody against activated protein C) - Orphan designation - Commission Decision (2026) 6008 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000349775
Apri →
EU/3/26/3275 (Sirius Regulatory Consulting EU Limited)
EU/3/26/3275 (Active substance: Insulin, human) - Orphan designation - Commission Decision (2026) 5997 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000307462
Apri →
EU/3/25/3076 (FGK Representative Service GmbH)
EU/3/25/3076 (Active substance: 4-Amino-1-[(2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-(hydroxymethyl)pyrimidin-2-one) - Transfer of orphan designation - Commission Decision (2026) 5988 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000319314
Apri →
EU/3/26/3285 (Bristol-Myers Squibb Pharma EEIG)
EU/3/26/3285 (Active substance: Zolacabtagene autoleucel) - Orphan designation - Commission Decision (2026) 6007 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000348467
Apri →
Pombiliti (Amicus Therapeutics Europe Limited)
Pombiliti (Active substance: cipaglucosidase alfa) - Centralised - Yearly update - Commission Decision (2026) 5989 of Thu, 20 Aug 2026
Apri →
EU/3/26/3283 (Alnylam Netherlands B.V.)
EU/3/26/3283 (Active substance: RNA, (Um-sp-(2′-deoxy-2′-fluoro)A-sp-Gm-Am-Am-(2′-deoxy-2′-fluoro)A-Cm-Um-Cm-Am-Um-Am-Gm-(2′-deoxy-2′-fluoro)C-Gm-(2′-deoxy-2′-fluoro)A-Um-Um-Gm-Cm-Am-sp-Cm-sp-Am), complex with RNA (Um-sp-Gm-sp-Cm-Am-Am-Um-(2′-deoxy-2′-fluoro)C-Gm-(2′-deoxy-2′-fluoro)C-(2′-deoxy-2′-fluoro)U-(2′-deoxy-2′-fluoro)A-Um-Gm-Am-Gm-Um-Um-Um-Cm-Um-Am)…
Apri →
EU/3/26/3281 (Maxia Strategies-Europe Limited)
EU/3/26/3281 (Active substance: Bimiralisib) - Orphan designation - Commission Decision (2026) 6003 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000338542
Apri →
EU/3/26/3280 (Vanda Pharmaceuticals Netherlands B.V.)
EU/3/26/3280 (Active substance: Imsidolimab) - Orphan designation - Commission Decision (2026) 6002 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000335063
Apri →
EU/3/26/3279 (AstraZeneca AB)
EU/3/26/3279 (Active substance: Small interfering RNA against the human PLN gene, conjugated to a bicyclic peptide, sodium salt) - Orphan designation - Commission Decision (2026) 6001 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000334779
Apri →
EU/3/26/3278 (Oxcia AB)
EU/3/26/3278 (Active substance: 4-(4-Bromo-2-oxo-3H-benzimidazol-1-yl)-N-(4-iodophenyl)piperidine-1-carboxamide) - Orphan designation - Commission Decision (2026) 6000 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000333976
Apri →
EU/3/26/3276 (Crinetics Pharmaceuticals Europe GmbH)
EU/3/26/3276 (Active substance: Paltusotine) - Orphan designation - Commission Decision (2026) 5998 of Thu, 20 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/OD/0000323219
Apri →

AboutPharma – Legal & Regulatory (1)

Al vaglio dell’Ue la nascita di un Centro per l’eccellenza clinica
Apri →

Ti è utile? Inoltralo a un collega.

Per iscriversi: email vuota a osservatorio-pharma+subscribe@googlegroups.com (da qualsiasi indirizzo; poi rispondi all’email di conferma) — oppure groups.google.com/g/osservatorio-pharma (con account Google)

Servizio indipendente, gratuito. — Privacy

← Torna all'archivio