4771 results
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Human medicine European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius) (updated)
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,
, Revision: 9, Authorised, Last updated: 24/11/2023
PDF/185.28 KB) (PDF/185.28 KB) Italian (PDF/159.14 KB) (PDF/159.14 … -
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Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,, Revision: 5, Authorised, Last updated: 20/11/2023
PDF/164.71 KB) (PDF/164.71 KB) Italian (PDF/140.83 KB) (PDF/140.83 … -
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Human medicine European public assessment report (EPAR): Pemetrexed Lilly
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 14/09/2015,, Revision: 7, Withdrawn, Last updated: 26/11/2021
PDF/723.57 KB) (PDF/723.57 KB) Italian (PDF/660.44 KB) (PDF/660.44 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001538-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: Xessential hypertension Oral use Zentiva k.s. Czech Republic E-mail … application submitted by Zentiva k.s. on 9 July 2013 under … decision is addressed to Zentiva k.s., U kabelovny 130, 102 … -
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Human medicine European public assessment report (EPAR): Azilect
rasagiline, Parkinson Disease
Date of authorisation: 21/02/2005, Revision: 23, Authorised, Last updated: 18/08/2023PDF/96.68 KB) (PDF/96.68 KB) Italian (PDF/75.07 KB) (PDF/75.07 … -
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Human medicine European public assessment report (EPAR): Buvidal
buprenorphine, Opioid-Related Disorders
Date of authorisation: 20/11/2018, Revision: 8, Authorised, Last updated: 16/08/2023PDF/113.76 KB) (PDF/113.76 KB) Italian (PDF/93.18 KB) (PDF/93.18 … -
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Human medicine European public assessment report (EPAR): Aerius
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 50, Authorised, Last updated: 02/08/2023PDF/96.11 KB) (PDF/96.11 KB) Italian (PDF/97.71 KB) (PDF/97.71 … -
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Human medicine European public assessment report (EPAR): Insulin Human Winthrop
Insulin human, Diabetes Mellitus
Date of authorisation: 17/01/2007, Revision: 15, Withdrawn, Last updated: 30/04/2018PDF/653.39 KB) (PDF/653.39 KB) Italian (PDF/503.81 KB) (PDF/503.81 … -
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 8, Withdrawn, Last updated: 03/02/2023
PDF/722.62 KB) (PDF/722.62 KB) Italian (PDF/663.19 KB) (PDF/663.19 … -
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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
PDF/748.24 KB) (PDF/748.24 KB) Italian (PDF/736.11 KB) (PDF/736.11 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001344-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/04/2018, Last updated: 26/07/2018, Compliance check: XContact for public enquiries Zentiva, k.s. Tel.: +420 267243574 … -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrochlorothiazide, Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002174-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/10/2017, Last updated: 12/02/2018, Compliance check: XContact for public enquiries Zentiva, k.s. Tel. +42 267242361 E-mail … application submitted by Zentiva, k.s. on 4 May 2017 under … decision is addressed to Zentiva, k.s., U kabelovny 130, 102 … -
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Human medicine European public assessment report (EPAR): Fotivda
tivozanib, Carcinoma, Renal Cell
Date of authorisation: 24/08/2017,
, Revision: 9, Authorised, Last updated: 17/07/2023
PDF/90.4 KB) (PDF/90.4 KB) Italian (PDF/72.18 KB) (PDF/72.18 … -
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 10, Authorised, Last updated: 27/10/2023
PDF/117.8 KB) (PDF/117.8 KB) Italian (PDF/97.6 KB) (PDF/97.6 KB … -
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Opinion/decision on a Paediatric investigation plan (PIP): Indapamide, Perindopril erbumine, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001948-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/09/2016, Last updated: 27/10/2016, Compliance check: XContact for public enquiries Zentiva, k.s. Czech Republic Tel … application submitted by Zentiva, k.s. on 18 April 2016 under … decision is addressed to Zentiva, k.s., U kabelovny, 102 37 … -
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Human medicine European public assessment report (EPAR): Enyglid
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2009,, Revision: 9, Authorised, Last updated: 14/12/2022
PDF/91.79 KB) (PDF/91.79 KB) Italian (PDF/72 KB) (PDF/72 KB) Latvian … -
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Opinion/decision on a Paediatric investigation plan (PIP): Telmisartan, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001552-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 07/03/2014, Last updated: 16/04/2014, Compliance check: XContact for public enquiries Zentiva k.s. Czech Republic E-mail … application submitted by Zentiva k.s. on 25 September 2013 … decision is addressed to Zentiva k.s., U kabelovny 130, 102 … -
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Human medicine European public assessment report (EPAR): Bortezomib Hospira
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 09/10/2023
PDF/116.32 KB) (PDF/116.32 KB) Italian (PDF/98.25 KB) (PDF/98.25 … -
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Human medicine European public assessment report (EPAR): Vydura
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 5, Authorised, Last updated: 05/06/2023
PDF/138.05 KB) (PDF/138.05 KB) Italian (PDF/117.4 KB) (PDF/117.4 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Perindopril erbumine, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
PIP number: EMEA-001467-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 23/09/2013, Last updated: 15/11/2013, Compliance check: XContact for public enquiries Zentiva k.s. Czech Republic Email … application submitted by Zentiva k.s. on 12 April 2013 under … decision is addressed to Zentiva k.s., U kabelovny, 102 37 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Candesartan cilexetil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001319-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 22/10/2012, Last updated: 27/11/2012, Compliance check: XContact for public enquiries Zentiva k.s. Czech Republic blanka.zoubkova@zentiva.com … application submitted by Zentiva k.s. on 1 June 2012 under … decision is addressed to Zentiva k.s., U kabelovny 130, 102 … -
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Human medicine European public assessment report (EPAR): Ogluo
Glucagon, Diabetes Mellitus
Date of authorisation: 11/02/2021, Revision: 5, Authorised, Last updated: 26/05/2023PDF/154.15 KB) (PDF/154.15 KB) Italian (PDF/131.28 KB) (PDF/131.28 … -
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Human medicine European public assessment report (EPAR): Circadin
melatonin, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/06/2007, Revision: 34, Authorised, Last updated: 17/05/2023PDF/144.38 KB) (PDF/144.38 KB) Italian (PDF/127.02 KB) (PDF/127.02 … -
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Human medicine European public assessment report (EPAR): Neofordex
dexamethasone, Multiple Myeloma
Date of authorisation: 16/03/2016, Revision: 11, Authorised, Last updated: 17/05/2023PDF/92.86 KB) (PDF/92.86 KB) Italian (PDF/83.76 KB) (PDF/83.76 … -
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Human medicine European public assessment report (EPAR): Abiraterone Accord
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021,, Revision: 1, Authorised, Last updated: 25/09/2023
PDF/158.77 KB) (PDF/158.77 KB) Italian (PDF/135.84 KB) (PDF/135.84 …