19156 results
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Human medicine European public assessment report (EPAR): Invanz
ertapenem sodium, Community-Acquired Infections; Streptococcal Infections; Staphylococcal Infections; Gram-Negative Bacterial Infections; Surgical Wound Infection; Pneumonia, Bacterial
Date of authorisation: 18/04/2002, Revision: 26, Authorised, Last updated: 25/10/2022Diseases Lung Diseases Community-Acquired Infections Streptococcal … Authorised ertapenem Overview This is a summary … within the abdomen; community-acquired pneumonia (infection of the … -
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Withdrawn application: Ertapenem Hospira
ertapenem, date of withdrawal: 13/09/2016, Initial authorisation, Last updated: 06/12/2016Ertapenem Hospira: Withdrawn applicatio … ertapenem Overview On 13 September … marketing authorisation for Ertapenem Hospira, for the treatment … -
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Human medicine European public assessment report (EPAR): Ertapenem SUN
ertapenem sodium, Bacterial Infections
Date of authorisation: 15/07/2022,
, Authorised, Last updated: 21/11/2022
Ertapenem SUN Bacterial Infections … Authorised ertapenem Overview Ertapenem SUN is an antibiotic. It … within the abdomen; community-acquired pneumonia (infection of the … -
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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Date of authorisation: 01/09/2014, Revision: 1, Withdrawn, Last updated: 28/04/2017Clopidogrel/Acetylsalicylic acid Teva Acute Coronary Syndrome Myocardial … Clopidogrel/Acetylsalicylic acid Teva … Clopidogrel/Acetylsalicylic acid Teva, INN-clopidogrel/acetylsalicylic … -
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan
Acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 02/08/2022
Clopidogrel / Acetylsalicylic acid Mylan Cardiovascular Diseases Heart … Processes Necrosis Infarction Acute Coronary Syndrome Myocardial … Clopidogrel / Acetylsalicylic acid Mylan … -
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Human medicine European public assessment report (EPAR): DuoPlavin
clopidogrel, Acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 29, Authorised, Last updated: 31/03/2023Processes Ischemia Infarction Necrosis Acute Coronary Syndrome Myocardial … clopidogrel / acetylsalicylic acid … authorised provided the source is acknowledged. EMA/886716/2022 EMEA/H/C/001143 … -
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Human medicine European public assessment report (EPAR): Ibandronic acid Accord
ibandronic acid, Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance
Date of authorisation: 18/11/2012,, Revision: 14, Authorised, Last updated: 05/01/2023
Ibandronic acid Accord Cancer Neoplasms Wounds … Ibandronic acid Accord … authorised provided the source is acknowledged. 22 November 2012 EMA/393905/2006 … -
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Human medicine European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)
clopidogrel, Acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 22, Authorised, Last updated: 13/11/2019Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover) Cardiovascular … Processes Necrosis Infarction Ischemia Acute Coronary Syndrome Myocardial … Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis (updated)
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,, Revision: 15, Authorised, Last updated: 01/06/2023
Zoledronic acid Actavis Wounds and Injuries Fractures … Authorised zoledronic acid Overview This is a summary … report (EPAR) for Zoledronic acid Actavis. It explains how the Committee … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Accord
zoledronic acid monohydrate, Hypercalcemia; Fractures, Bone; Cancer
Date of authorisation: 16/01/2014,, Revision: 9, Authorised, Last updated: 24/01/2022
Zoledronic Acid Accord Calcium Metabolism Disorders Metabolic … Zoledronic Acid Accord … Assessment report Zoledronic Acid Accord International non-proprietary … -
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Human medicine European public assessment report (EPAR): Aclasta
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/04/2005, Revision: 31, Authorised, Last updated: 16/01/2023Aclasta Bone Diseases, Metabolic Metabolic … Authorised zoledronic acid Overview This is a summary … assessment report (EPAR) for Aclasta. It explains how the The committee … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 14, Authorised, Last updated: 20/04/2023
Zoledronic acid Mylan Wounds and Injuries Fractures … Authorised zoledronic acid Overview This is a summary … report (EPAR) for Zoledronic acid Mylan. It explains how the … -
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Human medicine European public assessment report (EPAR): Ibandronic Acid Teva
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone; Osteoporosis, Postmenopausal
Date of authorisation: 17/09/2010,, Revision: 12, Authorised, Last updated: 22/11/2022
Ibandronic Acid Teva Cancer Neoplasms Skin … Authorised ibandronic acid Overview This is a summary … report (EPAR) for Ibandronic Acid Teva. It explains how the … -
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 9, Authorised, Last updated: 06/07/2022
Ibandronic Acid Sandoz Skin and Connective … Authorised ibandronic acid Overview This is a summary … report (EPAR) for Ibandronic Acid Sandoz. It explains how the … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva
zoledronic acid, Fractures, Bone; Cancer
Date of authorisation: 16/08/2012,, Revision: 14, Authorised, Last updated: 11/10/2021
Zoledronic acid Teva Wounds and Injuries Cancer Neoplasms Fractures … Zoledronic acid Teva … authorised provided the source is acknowledged. EMA/552883/2014 EMEA/H/C/002439 … -
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,
, 
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, Revision: 5, Authorised, Last updated: 15/12/2021
Chenodeoxycholic acid Leadiant (previously known … known as Chenodeoxycholic acid sigma-tau) Congenital, Hereditary … Chenodeoxycholic acid Leadiant (previously known … -
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Veterinary medicine European public assessment report (EPAR): VarroMed
oxalic acid dihydrate, formic acid, Bees
Date of authorisation: 02/02/2017, Revision: 3, Authorised, Last updated: 11/01/2022Authorised oxalic acid dihydrate / formic acid Overview This is a summary … substance responsible for the activity of a medicine active substances oxalic … public VarroMed oxalic acid dihydrate / formic acid This is a summary of the … -
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Veterinary medicine European public assessment report (EPAR): Hydrocortisone aceponate Ecuphar (previously Cortacare)
hydrocortisone aceponate, Dogs
Date of authorisation: 27/08/2018, Revision: 3, Authorised, Last updated: 04/01/2022Hydrocortisone aceponate Ecuphar (previously Cortacare … Hydrocortisone aceponate Ecuphar (previously Cortacare … authorised provided the source is acknowledged. EMA/406528/2018 EMEA/V/C/004689 … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,, Revision: 18, Authorised, Last updated: 09/11/2021
Zoledronic Acid Hospira Calcium Metabolism … Zoledronic Acid Hospira … authorised provided the source is acknowledged. 22 November 2012 EMA/393905/2006 … -
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Human medicine European public assessment report (EPAR): Ulipristal Acetate Gedeon Richter
ulipristal acetate, Leiomyoma
Date of authorisation: 27/08/2018, Revision: 1, Withdrawn, Last updated: 09/07/2021Ulipristal Acetate Gedeon Richter Leiomyoma … patient safety ulipristal acetate Overview The The approval … authorisation for Ulipristal Acetate Gedeon Richter was withdrawn … -
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Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
Zoledronic acid medac Wounds and Injuries Cancer Neoplasms Fractures … Zoledronic acid medac … authorised provided the source is acknowledged. 22 November 2012 EMA/393905/2006 … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,, Revision: 11, Withdrawn, Last updated: 12/12/2018
Zoledronic acid Teva Pharma Osteoporosis Osteitis … Withdrawn zoledronic acid Overview The marketing authorisation … authorisation for Zoledronic acid Teva Pharma has been withdrawn … -
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Human medicine European public assessment report (EPAR): Zometa
zoledronic acid, zoledronic acid monohydrate, Cancer; Fractures, Bone
Date of authorisation: 20/03/2001, Revision: 36, Authorised, Last updated: 09/07/2021zoledronic acid … authorised provided the source is acknowledged. EMA/681281/2015 EMEA/H/C/000336 … public Zometa Zoledronic acid This is a summary of the … -
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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
Zoledronic acid Teva Generics Osteoporosis Osteitis … Withdrawn zoledronic acid Overview The marketing authorisation … authorisation for Zoledronic Acid Teva Generics has been withdrawn … -
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Human medicine European public assessment report (EPAR): Bondenza (previously Ibandronic Acid Roche)
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 16, Withdrawn, Last updated: 13/05/2013denza (previously Ibandronic Acid Roche) Osteoporosis, Postmen … Withdrawn ibandronic acid Overview The marketing authorisation … gt;Bondenza (previously Ibandronic Acid Roche)EMEA/H/C/000502ibandronic …