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Pubblicazioni dal 24/09/2026 06:25 a ora — 52 news

AIFA (1)

Anticorpi monoclonali per l’Alzheimer: AIFA incontra le Aziende produttrici
DisponibilitĂ  a definire modelli di monitoraggio nella pratica clinica per generare nuove evidenze.
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Gazzetta Ufficiale – Serie Generale (10)

AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Claxon» (26A04881)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Aurozeb» (26A04882)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Apixaban Glenmark». (26A04883)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'importazione parallela del medicinale per uso umano «Lacipil» (26A04884)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'immissione in commercio del medicinale per uso umano, a base di carbidopa e levodopa, «Carbidopa e Levodopa Aurobindo». (26A04917)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Autorizzazione all'immissione in commercio del medicinale per uso umano, a base di oseltamivir, «Viruflu» (26A04918)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Rinnovo dell'autorizzazione all'immissione in commercio del medicinale omeopatico «Metatox 3». (26A04951)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Rinnovo dell'autorizzazione all'immissione in commercio del medicinale omeopatico «Sabalplex». (26A04952)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Revoca, su rinuncia, dell'autorizzazione all'importazione parallela dei medicinali per uso umano «Diprosone», «Enterogermina» e «Ibustrin». (26A04953)
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AGENZIA ITALIANA DEL FARMACO - COMUNICATO
Rettifica dell'estratto della determina AAM/PPA n. 354/2026 del 19 giugno 2026 concernente la modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Rivaroxaban Dr Reddy's». (26A04965)
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EMA – Regulatory & procedural guidelines (2)

Member states contact points for review of national implementation of quick response (QR) codes of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures
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INS-GCP-1 procedure for coordinating good-clinical-practice inspections requested by the CHMP
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EMA – What's new (21)

Clinical requirements for medicines intended for the treatment of sickle cell disease
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Draft guideline on the clinical requirements for medicines intended for the treatment of sickle cell disease
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Clinical requirements for medicines intended for the treatment of thalassaemia
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Draft guideline on the clinical requirements for medicines intended for the treatment of thalassaemia
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Sponsor guidance: New safety module on the annual safety report
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Article 57 product data
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Human medicines European public assessment report (EPAR): Pregabalin Viatris Pharma (previously Pregabalin Pfizer), pregabalin, Date of authorisation: 10/04/2014, Revision: 39, Status: Authorised
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Human medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 18, Status: Authorised
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Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Date of authorisation: 21/03/2014, Revision: 33, Status: Authorised
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PDCO minutes of the 21-24 July 2026 meeting
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18th Industry Standing Group (ISG) meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 21 September 2026, 09:00 (CEST) to 21 September 2026, 12:30 (CEST)
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Human medicines European public assessment report (EPAR): Susvimo, ranibizumab, Date of authorisation: 18/09/2026, Status: Authorised
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Human medicines European public assessment report (EPAR): Jorveza, budesonide, Date of authorisation: 08/01/2018, Revision: 8, Status: Authorised
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Human medicines European public assessment report (EPAR): Padcev, enfortumab vedotin, Date of authorisation: 13/04/2022, Revision: 10, Status: Authorised
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Human medicines European public assessment report (EPAR): Relistor, methylnaltrexone bromide, Date of authorisation: 01/07/2008, Revision: 22, Status: Authorised
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Human medicines European public assessment report (EPAR): Degevma, denosumab, Date of authorisation: 17/11/2025, Revision: 1, Status: Authorised
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Human medicines European public assessment report (EPAR): Atazanavir Viatris (previously Atazanavir Mylan), atazanavir, Date of authorisation: 22/08/2016, Revision: 22, Status: Authorised
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Human medicines European public assessment report (EPAR): Givlaari, givosiran, Date of authorisation: 02/03/2020, Revision: 8, Status: Authorised
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PSUSA/00010431/202510
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Human medicines European public assessment report (EPAR): Ruxolitinib Viatris, ruxolitinib hemifumarate, Date of authorisation: 18/09/2026, Status: Authorised
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Human medicines European public assessment report (EPAR): Nezglyal, leriglitazone, Date of authorisation: 21/09/2026, Status: Authorised
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HMA – Human Medicines (6)

Pyridoxine hydrochloride/lysozyme hydrochlorideDate of publication: 23/09/2026
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Added in September 2026 23 September NEW - PSUR assessment for Iberogast Balance and Iberogast SelectNEW - PSUR…
Added in September 2026 23 September NEW - PSUR assessment for Iberogast Balance and Iberogast SelectNEW - PSUR assessment for Pyridoxine hydrochloride/ lysozyme hydrochlorideNEW - Recommendations on submission dates in 2027 for Applications of the MRPNEW - Recommendations on submission dates in 2027 for Applications of the DCPNEW - Overview of CMDh referral timetables 2027UPDATE - BPG for the processing of grouped applications in MRP (Chapter 6)NEW - Report from the meeting held on 15-17…
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Iberogast Select / Iberogast BalanceDate of publication: 23/09/2026
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Recommendations on submission dates for Applications of the Mutual Recognition Procedure
Recommendations on submission dates in 2027 for Applications of the MRP (September 2026)Recommendations on submission dates in 2026 for Applications of the MRP (October 2025)
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Recommendations on submission dates for Applicants of the DCP
Recommendations on submission dates in 2027 for Applications of the DCP (September 2026)Recommendations on submission dates in 2026 for Applications of the DCP (October 2025)
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Overview of timetables
Overview of timetables 2027 (September 2026)Overview of timetables 2026 (September 2025)
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EU Union Register of Medicinal Products (12)

ELREXFIO (Pfizer Europe MA EEIG)
ELREXFIO (Active substance: elranatamab) - Centralised - Annual renewal - Commission Decision (2026) 6834 of Mon, 21 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/R/0000347279
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Otulfi (Fresenius Kabi Deutschland GmbH)
Otulfi (Active substance: ustekinumab) - Centralised - 2-Monthly update - Commission Decision (2026) 6738 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/VR/0000356308
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Idacio (Fresenius Kabi Deutschland GmbH)
Idacio (Active substance: adalimumab) - Centralised - Yearly update - Commission Decision (2026) 6765 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000368103
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LYROKAUL (LIB Therapeutics B.V.)
LYROKAUL (Active substance: Lerodalcibep) - Centralised - Authorisation - Commission Decision (2026) 6743 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMEA/H/C/006694/0000
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Yesafili (Biosimilar Collaborations Ireland Limited)
Yesafili (Active substance: aflibercept) - PSUSA - Modification - Commission Decision (2026) 6754 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/PSUR/0000336116
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FABHALTA (Novartis Europharm Limited)
FABHALTA (Active substance: iptacopan) - Centralised - Yearly update - Commission Decision (2026) 6734 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/YU/0000372342
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Tevimbra (BeOne Medicines Ireland Limited)
Tevimbra (Active substance: tislelizumab) - PSUSA - Modification - Commission Decision (2026) 6752 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/PSUR/0000336087
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Evlarco (A. Menarini International Licensing S.A.)
Evlarco (Active substance: obicetrapib / ezetimibe) - Centralised - Authorisation - Commission Decision (2026) 6747 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMEA/H/C/006517/0000
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Ubeslo (A. Menarini International Licensing S.A.)
Ubeslo (Active substance: Obicetrapib) - Centralised - Authorisation - Commission Decision (2026) 6746 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMEA/H/C/006516/0000
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Riociguat Accord (Accord Healthcare S.L.U.)
Riociguat Accord (Active substance: riociguat) - Centralised - Authorisation - Commission Decision (2026) 6750 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMEA/H/C/006838/0000
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Litfulo (Pfizer Europe MA EEIG)
Litfulo (Active substance: ritlecitinib) - PSUSA - Modification - Commission Decision (2026) 6744 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/PSUR/0000336091
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Riltrava Aerosphere (AstraZeneca AB)
Riltrava Aerosphere (Active substance: formoterol / glycopyrronium bromide / budesonide) - Centralised - Renewal - Commission Decision (2026) 6768 of Fri, 18 Sep 2026 - European Medicines Agency (EMA) procedure number: EMA/R/0000340519, EMA/X/0000287672
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