742 results
-
List item
Human medicine European public assessment report (EPAR): Levodopa/Carbidopa/Entacapone Orion
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 23/08/2011, Revision: 11, Authorised, Last updated: 15/12/2020Levodopa/Carbidopa/Entacapone Orion Parkinson Disease … Authorised levodopacarbidopaentacapone Overview This is a summary … assessment report (EPAR) for Levodopa/Carbidopa/Entacapone Orion. It explains how the … -
List item
Human medicine European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 11/11/2013, Revision: 8, Authorised, Last updated: 14/12/2020Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) Parkinson Disease … Authorised levodopacarbidopaentacapone Overview This is a summary … three active substances: levodopa, carbidopa and entacapone. It is used to treat adults … -
List item
Human medicine European public assessment report (EPAR): Stalevo
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 17/10/2003, Revision: 27, Authorised, Last updated: 21/12/2020Authorised levodopacarbidopaentacapone Overview This is a summary … three 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 … -
List item
Withdrawn application: Stalevo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 … -
List item
Human medicine European public assessment report (EPAR): Entacapone Teva
entacapone, Parkinson Disease
Date of authorisation: 18/02/2011,
, Revision: 9, Authorised, Last updated: 11/03/2021
Entacapone Teva Parkinson Disease … Authorised entacapone Overview This is a summary … assessment report (EPAR) for Entacapone Teva. It explains how the Committee … -
List item
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Date of authorisation: 19/11/2015, Revision: 3, Withdrawn, Last updated: 09/08/2018Withdrawn levodopacarbidopa Overview The marketing authorisation … Numient levodopa carbidopa levodopa carbidopa … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
Levodopa/carbidopa/entacapone product-specific bioequivalence guidance
Last updated: 03/01/2017Levodopa/carbidopa/entacapone product-specific bioequivalence … of the bioequivalence of levodopa, carbidopa and entacapone. … Levodopa_Carbidopa_Entacapone Part B 30 Churchill …
-
List item
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 … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Entacapone Orion
entacapone, Parkinson Disease
Date of authorisation: 18/08/2011, Revision: 9, Authorised, Last updated: 04/11/2020Entacapone Orion Parkinson Disease … Authorised entacapone Overview This is a summary … assessment report (EPAR) for Entacapone Orion. It explains how the … -
List item
Human medicine European public assessment report (EPAR): Comtan
entacapone, Parkinson Disease
Date of authorisation: 22/09/1998, Revision: 25, Authorised, Last updated: 28/04/2021Authorised entacapone Overview This is a summary … contains the active substance entacapone. It is available as brown-orange … Comtan is used together with levodopa (either a combination of … -
List item
Human medicine European public assessment report (EPAR): Comtess
entacapone, Parkinson Disease
Date of authorisation: 16/09/1998, Revision: 27, Authorised, Last updated: 04/11/2020Authorised entacapone Overview This is a summary … contains the active substance entacapone. It is available as brown-orange … Comtess is used together with levodopa (either a combination of … -
List item
Human medicine European public assessment report (EPAR): Inbrija
levodopa, Parkinson Disease
Date of authorisation: 19/09/2019, Revision: 2, Authorised, Last updated: 06/04/2021Authorised levodopa Overview Inbrija is a medicine … treatment of a combination of levodopa and an inhibitor of dopa-decarboxylase … contains the active substance levodopa. How is Inbrija used? Inbrija … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Pramipexole Teva
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 18/12/2008,, Revision: 21, Authorised, Last updated: 09/03/2021
Pramipexole Teva Parkinson Disease … EPAR). What is Pramipexole Teva? Pramipexole Teva is a medicine containing … and 0.7 mg). Pramipexole Teva is a ‘generic medicine’ … -
List item
Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn applicati … authorisation) Pioglitazone Teva Generics pioglitazone On … medicinal product Pioglitazone Teva Generics 15, 30, 45 mg tablet … -
List item
Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … application for Clopidogrel Teva Pharma clopidogrel … clopidogrel On 22 April 2009, Teva Pharma B.V. officially notified … -
List item
Human medicine European public assessment report (EPAR): Telmisartan Teva (updated)
telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 11, Withdrawn, Last updated: 17/09/2021
Telmisartan Teva Hypertension … Telmisartan Teva … Public statement Telmisartan Teva Withdrawal of the marketing … -
List item
Human medicine European public assessment report (EPAR): Irbesartan Teva (updated)
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 15, Authorised, Last updated: 06/09/2021
Irbesartan Teva Hypertension … EPAR). What is Irbesartan Teva? Irbesartan Teva is a medicine that contains … 150 and 300 mg). Irbesartan Teva is a ‘ A generic medicine … -
List item
Human medicine European public assessment report (EPAR): Desloratadine Teva (updated)
desloratadine, Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Date of authorisation: 24/11/2011,, Revision: 17, Authorised, Last updated: 14/09/2021
Desloratadine Teva Rhinitis, Allergic, Perennial Rhinitis … EPAR) for Desloratadine Teva. It explains how the The committee … of use for Desloratadine Teva. What is Desloratadine Teva? Desloratadine Teva is a medicine containing … -
List item
Human medicine European public assessment report (EPAR): Capecitabine Teva (updated)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,
, , Revision: 15, Authorised, Last updated: 08/09/2021
Capecitabine Teva Colonic Neoplasms Breast … capecitabine Overview Capecitabine Teva is a cancer medicine that … bowel) cancer. Capecitabine Teva is used on its own or with … -
List item
Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 18, Authorised, Last updated: 19/08/2021
Levetiracetam Teva Epilepsy … levetiracetam Overview Levetiracetam Teva is an epilepsy medicine … whole brain. Levetiracetam Teva can also be used as an add-on …