851 results
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Human medicine European public assessment report (EPAR): Levodopa/Carbidopa/Entacapone Orion (updated)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 23/08/2011, Revision: 13, Authorised, Last updated: 16/01/2023Levodopa/Carbidopa/Entacapone Orion Nervous System Diseases Central … Authorised levodopacarbidopaentacapone Overview This is a summary … assessment report (EPAR) for Levodopa/Carbidopa/Entacapone Orion. It explains how the … -
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Human medicine European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) (updated)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 11/11/2013, Revision: 10, Authorised, Last updated: 16/01/2023Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) Nervous System Diseases Neurodegenerative … Authorised levodopacarbidopaentacapone Overview This is a summary … medicine. active substances : levodopa, carbidopa and entacapone. It is used to treat adults … -
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Human medicine European public assessment report (EPAR): Stalevo (updated)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 17/10/2003, Revision: 29, Authorised, Last updated: 13/01/2023Authorised levodopacarbidopaentacapone Overview This is a summary … medicine. active substances : levodopa, carbidopa and entacapone. It is available as a range … for the public Stalevo Levodopa/carbidopa/entacapone This is a summary of the … -
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Withdrawn application: Stalevo
levodopa, carbidopa, entacapone, date of withdrawal: 06/03/2009, Post-authorisation, Last updated: 10/03/2009non-proprietary name (INN): levodopa, carbidopa and entacapone On 6 March 2009, Orion … in adults who are starting levodopa treatment. What is Stalevo … Stalevo Stalevo levodopa carbidopa entacapone levodopa … -
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Human medicine European public assessment report (EPAR): Numient
levodopa, carbidopa, Parkinson Disease
Date of authorisation: 19/11/2015, Revision: 3, Withdrawn, Last updated: 09/08/2018Withdrawn levodopacarbidopa Overview The marketing authorisation … Numient levodopa carbidopa levodopa carbidopa … -
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Human medicine European public assessment report (EPAR): Entacapone Teva
entacapone, Parkinson Disease
Date of authorisation: 18/02/2011,
, Revision: 10, Authorised, Last updated: 28/09/2021
Entacapone Teva Nervous System Diseases Central … assessment report (EPAR) for Entacapone Teva. It explains how the Committee … the conditions of use for Entacapone Teva. Expand section Collapse section … -
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Opinion/decision on a Paediatric investigation plan (PIP): levodopa, carbidopa monohydrate, entacapone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002421-PIP01-18, Route(s) of administration: Intestinal use, Pharmaceutical form(s): Intestinal gel
Decision date: 03/01/2019, Last updated: 25/04/2019, Compliance check: XKey facts levodopa carbidopa monohydrate entacapone NeurologyP/0011/2019EMEA-002421-PIP01-18 … product specific waiver for levodopa … levodopa entacapone … -
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Orphan designation: levodopa, carbidopa for: Treatment of advanced idiopathic Parkinson's disease with severe motor fluctuations
Date of designation: 10/05/2001, Withdrawn, Last updated: 19/01/2016levodopacarbidopa Overview Please note that … Production AB, Sweden, for levodopa carbidopa (gastroenteral use) for the … dopamine precursor called levodopa is effective in the early … -
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Opinion/decision on a Paediatric investigation plan (PIP): levodopa, carbidopa
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002687-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 30/07/2020, Compliance check: XActive substance levodopa carbidopa Therapeutic area Neurology … levodopa carbidopa … -
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Levodopa/carbidopa/entacapone product-specific bioequivalence guidance
Last updated: 03/01/2017Levodopa/carbidopa/entacapone product-specific bioequivalence … Levodopa/carbidopa/entacapone product-specific bioequivalence … Levodopa_Carbidopa_Entacapone Part B 30 Churchill …
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015Tablet Oral use Belgium Teva Pharma Belgium NV Laarstraat … Desloratadine Desloratadine Teva 2,5 mg Orodispersible tablet … administration Belgium Teva Pharma Belgium NV Laarstraat … -
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Press release: Orion Corporation withdraws its application for an extension of indication for Stalevo (levodopa/carbidopa/entacapone)
Last updated: 10/03/2009of indication for Stalevo (levodopa/carbidopa/entacapone … authorised medicine Stalevo (levodopa/carbidopa/entacapone) film-coated tablets. On … use in the initiation of levodopa therapy in early Parkinson's … -
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Human medicine European public assessment report (EPAR): Entacapone Orion
entacapone, Parkinson Disease
Date of authorisation: 18/08/2011, Revision: 10, Authorised, Last updated: 10/11/2021Entacapone Orion Nervous System Diseases Central … assessment report (EPAR) for Entacapone Orion. It explains how the … the conditions of use for Entacapone Orion. Expand section Collapse … -
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Human medicine European public assessment report (EPAR): Comtess
entacapone, Parkinson Disease
Date of authorisation: 16/09/1998, Revision: 28, Authorised, Last updated: 05/11/2021contains the active substance entacapone. It is available as brown-orange … Comtess is used together with levodopa (either a combination of levodopa and benserazide or a combination … Comtess, INN-entacapone European Medicines … -
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Human medicine European public assessment report (EPAR): Comtan
entacapone, Parkinson Disease
Date of authorisation: 22/09/1998, Revision: 26, Authorised, Last updated: 26/10/2021contains the active substance entacapone. It is available as brown-orange … Comtan is used together with levodopa (either a combination of levodopa and benserazide or a combination … Comtan, INN-entacapone European Medicines … -
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Human medicine European public assessment report (EPAR): Inbrija
levodopa, Parkinson Disease
Date of authorisation: 19/09/2019, Revision: 4, Authorised, Last updated: 04/01/2022levodopa … hard capsule contains 42 mg levodopa. Each delivered dose contains … delivered dose contains 33 mg levodopa. For the full list of … -
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Opinion/decision on a Paediatric investigation plan (PIP): levodopa
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001874-PIP01-15, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder
Decision date: 22/04/2016, Last updated: 02/06/2016, Compliance check: XKey facts levodopa NeurologyP/0117/2016EMEA-001874-PIP01-15 … product specific waiver for levodopa (EMEA-001874-PIP01-15) PDF … product specific waiver for levodopa (EMEA-001874-PIP01-15 … -
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Human medicine European public assessment report (EPAR): Pramipexole Teva
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 18/12/2008,, Revision: 22, Authorised, Last updated: 23/11/2021
Pramipexole Teva Nervous System Diseases Central … section What is Pramipexole Teva? Pramipexole Teva is a medicine containing … and 0.7 mg). Pramipexole Teva is a ‘generic medicine’ … -
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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn applicati … Pioglitazone Teva Generics: Withdrawal of the … authorisation) Pioglitazone Teva Generics pioglitazone On … -
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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the … application for Clopidogrel Teva Pharma clopidogrel … -
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Human medicine European public assessment report (EPAR): Olanzapine Teva
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 29, Authorised, Last updated: 22/11/2022
Olanzapine Teva Schizophrenia Spectrum and … EPAR). What is Olanzapine Teva? Olanzapine Teva is a medicine containing … in the mouth. Olanzapine Teva is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 13, Authorised, Last updated: 17/11/2022
Lamivudine Teva Infections Communicable … Lamivudine Teva … for the public Lamivudine Teva lamivudine This is a summary … -
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Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 19, Authorised, Last updated: 06/07/2022
Levetiracetam Teva Nervous System Diseases Central … levetiracetam Overview Levetiracetam Teva is an epilepsy medicine … whole brain. Levetiracetam Teva can also be used as an add-on … -
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Human medicine European public assessment report (EPAR): Sildenafil Teva
sildenafil, Erectile Dysfunction
Date of authorisation: 30/11/2009,, Revision: 17, Authorised, Last updated: 04/07/2022
Sildenafil Teva Male Urogenital Diseases Genital … Sildenafil Teva … Sildenafil Teva, INN-sildenafil 7 … -
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Human medicine European public assessment report (EPAR): Imatinib Teva
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 18, Authorised, Last updated: 09/06/2022
Imatinib Teva Leukemia, Myelogenous, Chronic … Imatinib Teva … Imatinib Teva, INN-imatinib 30 Churchill …