7993 results
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,
, Revision: 8, Authorised, Last updated: 09/11/2023
lmanco (previously Tadalafil Generics) Respiratory Tract Diseases Lung … tadalafil. Talmanco is a ‘ A generic medicine is a medicine that … company can only market a generic medicine once the 10-year … -
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Withdrawn application: Pioglitazone Teva Generics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date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn application … Pioglitazone Teva Generics: Withdrawal of the marketing … authorisation) Pioglitazone Teva Generics pioglitazone On 22 September … -
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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Date of authorisation: 27/03/2014,, Revision: 2, Withdrawn, Last updated: 08/08/2016
Zoledronic acid Teva Generics Osteoporosis Osteitis Defor … for Zoledronic Acid Teva Generics has been withdrawn at the … documents Zoledronic acid Teva Generics : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Generics B.V.
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014
Clopidogrel Teva Generics B.V. Peripheral Vascular … Clopidogrel Teva Generics B.V … Clopidogrel Teva Generics B.V., INN-clopidogrel … -
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Opinion/decision on a Paediatric investigation plan (PIP): Indapamide, Telmisartan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003151-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 13/04/2022, Last updated: 19/04/2023, Compliance check: XKey facts Indapamide Telmisartan Cardiovascular … waiver for telmisartan / indapamide (EMEA-003151-PIP01-21) PDF … 19/04/2023 EMA/145596/2022 Generic Topics: Medicines Paediatri … -
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Opinion/decision on a Paediatric investigation plan (PIP): Indapamide, valsartan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003285-PIP01-22, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 30/12/2022, Last updated: 24/10/2023, Compliance check: XKey facts Indapamide valsartan Cardiovascular … specific waiver for valsartan / indapamide (EMEA-003285-PIP01-22) PDF … 24/10/2023 EMA/934658/2022 Generic Topics: Medicines Paediatri … -
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Opinion/decision on a Paediatric investigation plan (PIP): Indapamide, Perindopril (arginine)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003186-PIP01-22, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/06/2022, Last updated: 21/06/2023, Compliance check: XKey facts Indapamide Perindopril (arginine) Cardiovascular … perindopril (arginine) / indapamide (EMEA-003186- PIP01-22) PDF … 21/06/2023 EMA/365818/2022 Generic Topics: Medicines Paediatri … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, Indapamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002081-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release tablet
Decision date: 05/05/2017, Last updated: 04/07/2017, Compliance check: XActive substance Ramipril Indapamide Therapeutic area Cardiovascular … specific waiver for ramipril / indapamide (EMEA-002081-PIP01-16) in … specific waiver for ramipril / indapamide (EMEA-002081-PIP01-16) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): valsartan, Indapamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001377-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Prolonged-release tablet
Decision date: 27/02/2013, Last updated: 23/04/2013, Compliance check: XActive substance valsartan Indapamide Therapeutic area Cardiovascular … specific waiver for valsartan / indapamide (EMEA-001377-PIP01-12 … specific waiver for valsartan / indapamide (EMEA-001377-PIP01-12) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Telmisartan, Indapamide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002462-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/01/2019, Last updated: 26/04/2019, Compliance check: XActive substance Telmisartan Indapamide Therapeutic area Cardiovascular … Telmisartan Indapamide … -
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Human medicine European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 4, Authorised, Last updated: 23/06/2023
Viatris (previously Rivaroxaban Mylan) Cardiovascular Diseases Vascular … rivaroxaban Overview Rivaroxaban Mylan is an anticoagulant medicine … with aspirin. Rivaroxaban Mylan contains the The substance … -
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Opinion/decision on a Paediatric investigation plan (PIP): perindopril, Indapamide, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001355-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 27/02/2013, Last updated: 23/04/2013, Compliance check: XActive substance perindopril Indapamide amlodipine Therapeutic area … waiver for perindopril / indapamide / amlodipine (EMEA-001355-PIP01-12 … waiver for perindopril / indapamide / amlodipine (EMEA-001355- PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): perindopril, Indapamide, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001358-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 22/01/2013, Last updated: 03/04/2013, Compliance check: XActive substance perindopril Indapamide amlodipine Therapeutic area … waiver for perindopril / indapamide / amlodipine (EMEA-001358- PIP01-12 … waiver for perindopril / indapamide / amlodipine (EMEA-001358- PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): perindopril, Indapamide, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001337-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: XActive substance perindopril Indapamide amlodipine Therapeutic area … waiver for perindopril / indapamide / amlodipine (EMEA-001337-PIP01-12 … waiver for perindopril / indapamide / amlodipine (EMEA-001337- PIP01-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Indapamide, 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-000896-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 27/08/2010, Last updated: 06/10/2010, Compliance check: XActive substance Indapamide Amlodipine besilate Therapeutic … Decision Amlodipine besilate, Indapamide 7 Westferry Circus ● … product specific waiver for indapamide / amlodipine besilate, (EMEA-000896- PIP01-10 … -
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Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan)
clopidogrel hydrochloride, Peripheral Vascular Diseases; Stroke; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 21/09/2009,, Revision: 20, Authorised, Last updated: 01/07/2022
Pharma (previously Clopidogrel Mylan) Vascular Diseases Cardiovascular … substance clopidogrel and is a ‘generic medicine’. This means that … Plavix. For more information on generic medicines, see the question-and-answer … -
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Withdrawn application: Fingolimod Mylan
fingolimod, date of withdrawal: 08/05/2020, Initial authorisation, Last updated: 17/06/2020Fingolimod Mylan: Withdrawn application … Mylan Ireland Limited withdrew … authorisation of Fingolimod Mylan for the treatment of multiple … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015Aripiprazole Mylan: Withdrawn application … zole Overview On 7 May 2015, Generics (UK) Limited officially notified … authorisation for Aripiprazole Mylan, for the treatment of schizophrenia … -
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Withdrawn application: Rotigotine Mylan
rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018Rotigotine Mylan: Withdrawn application … Overview On 22 December 2017, Mylan SAS officially notified the … authorisation for Rotigotine Mylan, for the treatment of Parkinson's … -
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Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010Docetaxel Mylan: Withdrawn application … Overview On 8 March 2010, Mylan S.A.S. officially notified … authorisation for Docetaxel Mylan intended to be used to treat … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 08/01/2016, Initial authorisation, Last updated: 29/03/2016Aripiprazole Mylan: Withdrawn application … Overview On 8 January 2016, Mylan S.A.S. officially notified … authorisation for Aripiprazole Mylan, for the treatment of schizophrenia … -
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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: XActive substance Indapamide Perindopril erbumine Amlodipine … perindopril (erbumine) /indapamide (EMEA-001948-PIP01-16 … perindopril (erbumine) / indapamide (EMEA-001948-PIP01-16) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): perindopril arginine, Indapamide, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: P/17/2011, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 21/01/2011, Last updated: 24/02/2011, Compliance check: Xsubstance perindopril arginine Indapamide Amlodipine besilate Therapeutic … for perindopril arginine / indapamide / amlodipine besilate (EMEA-001048-PIP01-10 … for perindopril arginine / indapamide / amlodipine besilate (EMEA-001048-PIP01-10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine besilate, Indapamide, perindopril arginine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002849-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/12/2020, Last updated: 20/09/2021, Compliance check: Xsubstance Amlodipine besilate Indapamide perindopril arginine Therapeutic … for amlodipine (besilate)/ indapamide/ perindopril (arginine) (EMEA-002849-PIP01-20 … for amlodipine (besilate)/ indapamide/ perindopril (arginine) (EMEA-002849-PIP01-20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, atorvastatin, Indapamide, perindopril arginine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003173-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 20/05/2022, Last updated: 10/05/2023, Compliance check: Xsubstance amlodipine atorvastatin Indapamide perindopril arginine Therapeutic … perindopril (arginine) / indapamide / amlodipine (EMEA-003173-PIP01-21 … perindopril (arginine) / indapamide / amlodipine (EMEA-003173-PIP01-21 …