34 results
-
List item
Human medicine European public assessment report (EPAR): Sixmo
Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019,
, Revision: 4, Authorised, Last updated: 20/02/2023
-
List item
National expert: Giuseppe Capovilla, Italian Medicines Agency (updated)
- Declaration of interests - 79.91 KB | PDF
- Curriculum Vitae - 33.9 KB | PDF
S, RENZETTI V, SALVONI L, MOLTENI M, SALANDI A, TRABATTONI … S, RENZETTI V, SALVONI L, MOLTENI M, SALANDI A, TRABATTONI … -
List item
Press release: New long-lasting implant to treat opioid dependence
Last updated: 26/04/2019The applicant for Sixmo is L. Molteni & C. dei Fratelli Alitti … -
List item
National expert: Paola Minghetti, Italian Medicines Agency (updated)
- Declaration of interests - 81.41 KB | PDF
- Curriculum Vitae - 62.13 KB | PDF
myeloma 10/2011-(current) Molteni medical devices 12/2011-(current … -
List item
Human medicine European public assessment report (EPAR): Rizmoic (updated)
Naldemedine tosilate, Constipation
Date of authorisation: 18/02/2019,, Revision: 8, Authorised, Last updated: 09/03/2023
-
List item
Human medicine European public assessment report (EPAR): PecFent
fentanyl, Pain; Cancer
Date of authorisation: 31/08/2010, Revision: 23, Authorised, Last updated: 08/11/2022 -
List item
Human medicine European public assessment report (EPAR): Venclyxto
Venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 04/12/2016,, Revision: 15, Authorised, Last updated: 14/02/2023
-
List item
National expert: Anna Kajaste-Rudnitski, Italian Medicines Agency (updated)
- Declaration of interests - 80.46 KB | PDF
- Curriculum Vitae - 29.18 KB | PDF
corresponding author. 2. Molteni R, Biavasco R, Stefanoni … -
List item
National expert: Francesco Onida, Italian Medicines Agency (updated)
- Declaration of interests - 81.89 KB | PDF
- Curriculum Vitae - 51 KB | PDF
-
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2019
CHMP, Last updated: 26/04/2019Marketing-authorisation applicant L. Molteni & C. dei Fratelli Alitti … -
List item
Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/12/2003, EC decision date: 26/04/2004, Last updated: 13/05/2004 -
List item
Referral: Modified-released oral opioids
hydromorphone, morphine, oxycodone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2010, EC decision date: 20/04/2011, Last updated: 06/06/2011 -
List item
Referral: Calcitonins
calcitonin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/11/2002, EC decision date: 12/06/2003, Last updated: 02/03/2004Vial (12 doses) 1 Italy Molteni Farmaceutici L Molteni E C. Dei F .Lli Alitti Societa' … -
List item
Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005 -
List item
Referral: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen, dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015 -
List item
Orphan designation: Allopurinol sodium for: Treatment of perinatal asphyxia
Date of designation: 06/12/2012, Positive, Last updated: 23/05/2016kezelése Italian Sodio allopurinolo Trattamento dell’asfissia … -
List item
Orphan designation: Allopurinol sodium for: Treatment of perinatal asphyxia
Date of designation: 21/05/2015, Positive, Last updated: 30/06/2015kezelése Italian Sodio allopurinolo Trattamento dell’asfissia … -
List item
Public data from Article 57 database
Last updated: 17/10/2022 -
List item
List of medicines under additional monitoring (updated)
Last updated: 27/03/2023 -
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/01/2022 to 13/01/2022, Last updated: 07/10/2022 -
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020 -
List item
PRAC: Agendas, minutes and highlights (updated)
Last updated: 31/03/2023 -
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2022 to 10/06/2022, Last updated: 31/03/2022 -
List item
Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2021 to 10/06/2021, Last updated: 07/06/2021 -
List item
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023
PRAC, Last updated: 13/01/2023