81 results
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Opinion/decision on a Paediatric investigation plan (PIP): Lonquex, lipegfilgrastim
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001019-PIP01-10-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/01/2020, Last updated: 16/09/2021, Compliance check: V, 30/04/2020for public enquiries UAB "Sicor Biotech" Tel. +44 (0)20 7540 … -
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Opinion/decision on a Paediatric investigation plan (PIP): nitrous oxide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002340-PIP01-18, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Medicinal gas, liquefied
Decision date: 19/07/2018, Last updated: 28/11/2018, Compliance check: XItaliana Carburo Ossigeno Spa SICO Tel. +39 0382530059 E-mail: … -
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National expert: Vittorio Del Grosso, Italian Medicines Agency (updated)
- Declaration of interests - 80.52 KB | PDF
- Curriculum Vitae - 17.04 KB | PDF
Comtrol Analyst (Intern) SICOR SRL - TEVA GROUP (Italy) Training … Indication 02/2020-05/2020 SICOR SRL - TEVA GROUP Cross … -
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National expert: Maurizio Volterrani, Italian Medicines Agency (updated)
- Declaration of interests - 85.16 KB | PDF
- Curriculum Vitae - 20.43 KB | PDF
Director of the Study Centre SICOA (Italian Cardiologic Society … -
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Human medicine European public assessment report (EPAR): Tevagrastim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 16, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Ratiograstim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 15, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2012,
, Revision: 8, Withdrawn, Last updated: 17/10/2022
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Human medicine European public assessment report (EPAR): NeuroBloc
botulinum toxin type B, Torticollis
Date of authorisation: 22/01/2001, Revision: 33, Authorised, Last updated: 16/11/2022 -
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Human medicine European public assessment report (EPAR): Pazenir
paclitaxel, Breast Neoplasms
Date of authorisation: 06/05/2019,, Revision: 7, Authorised, Last updated: 15/03/2022
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Human medicine European public assessment report (EPAR): Luveris
lutropin alfa, Ovulation Induction; Infertility, Female
Date of authorisation: 29/11/2000, Revision: 21, Authorised, Last updated: 06/09/2022 -
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Human medicine European public assessment report (EPAR): Ovitrelle
choriogonadotropin alfa, Anovulation; Reproductive Techniques, Assisted; Infertility, Female
Date of authorisation: 02/02/2001, Revision: 22, Authorised, Last updated: 17/11/2022 -
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm GmbH
clopidogrel, Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/07/2009,, Revision: 12, Withdrawn, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Topotecan Teva
topotecan, Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 21/09/2009,, Revision: 8, Withdrawn, Last updated: 13/07/2018
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Human medicine European public assessment report (EPAR): Triumeq
dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections
Date of authorisation: 31/08/2014, Revision: 30, Authorised, Last updated: 08/11/2022 -
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Human medicine European public assessment report (EPAR): Repso
leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic
Date of authorisation: 14/03/2011,, Revision: 11, Withdrawn, Last updated: 21/04/2016
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Generics
zoledronic acid monohydrate, Osteoporosis; Osteitis Deformans
Date of authorisation: 27/03/2014,, Revision: 2, Withdrawn, Last updated: 08/08/2016
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Human medicine European public assessment report (EPAR): Leflunomide Teva
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 10/03/2011,, Revision: 6, Withdrawn, Last updated: 18/03/2014
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Human medicine European public assessment report (EPAR): Docetaxel Teva Pharma
docetaxel, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Date of authorisation: 21/01/2011,, Revision: 6, Withdrawn, Last updated: 21/01/2014
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Human medicine European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Teva
clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 01/09/2014, Revision: 1, Withdrawn, Last updated: 28/04/2017 -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 19/11/2014, Revision: 2, Withdrawn, Last updated: 31/01/2017 -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
budesonide, formoterol, Asthma
Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017 -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma (previously Clopidogrel HCS)
clopidogrel (as hydrochloride), Myocardial Infarction; Peripheral Vascular Diseases; Stroke
Date of authorisation: 21/09/2009,, Revision: 9, Withdrawn, Last updated: 24/10/2017
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Human medicine European public assessment report (EPAR): Clopidogrel HCS
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 8, Authorised, Last updated: 01/08/2018
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm
clopidogrel, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 5, Withdrawn, Last updated: 12/12/2013
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Human medicine European public assessment report (EPAR): Vylaer Spiromax
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 19/11/2014, Revision: 3, Withdrawn, Last updated: 26/01/2017