795 results
Keyword HYDROGEN PEROXIDE Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Hydrogen Peroxide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-001884-PIP02-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 20/05/2016, Last updated: 18/07/2016, Compliance check: XKey facts Hydrogen Peroxide DermatologyP/0143/2016EMEA-001884-PIP02-15 … product specific waiver for hydrogen peroxide (EMEA-001884-PIP02-15) PDF … product specific waiver for hydrogen peroxide (EMEA-001884-PIP02-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Hydrogen Peroxide
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Dermatology
PIP number: EMEA-001884-PIP03-18, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 25/07/2019, Last updated: 12/11/2019, Compliance check: XKey facts Hydrogen Peroxide DermatologyP/0268/2019EMEA-001884-PIP03-18 … granting of a waiver for hydrogen peroxide (45%) (EMEA-001884-PIP03-18 … Hydrogen Peroxide … -
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Referral: Basiron AC and associated names
benzoyl peroxide, Article 13 referrals
Status: European Commission final decision, opinion/position date: 28/03/2019, EC decision date: 04/07/2019, Last updated: 19/07/2019authorisation for Basiron AC (benzoyl peroxide 5% and 10% gel) in the EU … benzoyl peroxide … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate)
clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome; Peripheral Vascular Diseases; Myocardial Infarction; Stroke
Date of authorisation: 27/07/2009,
, Revision: 18, Authorised, Last updated: 10/06/2022
Clopidogrel Teva (hydrogen sulphate) Cardiovascular … Clopidogrel Teva (hydrogen sulphate … Clopidogrel Teva (hydrogen sulphate) clopidogrel clopidogrel … -
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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 1, Authorised, Last updated: 26/04/2022potassium citratepotassium hydrogen carbonate Overview Sibnayal … potassium citrate and potassium hydrogen carbonate. How is Sibnayal … potassium citrate and potassium hydrogen carbonate. Because the combination … -
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Human medicine European public assessment report (EPAR): Plavix
clopidogrel hydrogen sulfate, Stroke; Peripheral Vascular Diseases; Atrial Fibrillation; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 15/07/1998, Revision: 45, Authorised, Last updated: 20/01/2022ix clopidogrel clopidogrel hydrogen sulfate … -
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Human medicine European public assessment report (EPAR): Zyllt
clopidogrel (as hydrogen sulfate), Peripheral Vascular Diseases; Stroke; Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 28/09/2009,, Revision: 16, Authorised, Last updated: 10/06/2022
75 mg of clopidogrel (as hydrogen sulphate). Excipients with … clopidogrel clopidogrel (as hydrogen sulfate … -
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm
clopidogrel (as hydrogen sulfate), Myocardial Infarction; Acute Coronary Syndrome; Peripheral Vascular Diseases; Stroke
Date of authorisation: 18/02/2015,, Revision: 13, Authorised, Last updated: 07/06/2022
clopidogrel (as clopidogrel hydrogen sulphate) a non- competitive … ratiopharm clopidogrel clopidogrel (as hydrogen sulfate … -
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Human medicine European public assessment report (EPAR): Rivastigmine Actavis
rivastigmine hydrogen tartrate, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 16/06/2011,, Revision: 16, Authorised, Last updated: 10/05/2022
ActavisEMEA/H/C/002036rivastigmine hydrogen tartraterivastigmineDementiaAlzheimer … Actavis rivastigmine rivastigmine hydrogen tartrate … -
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Referral: Tiamulin hydrogen fumarate presented as premix for medicated feeding stuff and oral powder for in-feed use to be administered to pigs
tiamulin hydrogen fumarate, Article 35
Status: European Commission final decision, opinion/position date: 09/09/2020, EC decision date: 09/12/2020, Last updated: 05/02/2021Tiamulin hydrogen fumarate presented as premix … medicines containing tiamulin hydrogen fumarate presented as premix … medicines containing tiamulin hydrogen fumarate presented as premix … -
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Human medicine European public assessment report (EPAR): Clopidogrel BMS
clopidogrel (as hydrogen sulfate), Stroke; Peripheral Vascular Diseases; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 16/07/2008, Revision: 3, Withdrawn, Last updated: 26/01/2010substance clopidogrel (as hydrogen sulfate) International non-proprietary … BMS clopidogrel clopidogrel (as hydrogen sulfate … -
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Referral: Methylprednisolone injection for cattle
methylprednisolone hydrogen succinate, Article 35
Status: European Commission final decision, opinion/position date: 16/03/2017, EC decision date: 20/06/2017, Last updated: 04/08/2017containing methylprednisolone hydrogen succinate presented as solutions … containing methylprednisolone hydrogen succinate. What is methylprednisolone … What is methylprednisolone hydrogen succinate? Methylprednisolone … -
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Referral: Tiamutin
tiamulin hydrogen fumarate, Article 34
Status: European Commission final decision, opinion/position date: 10/03/2010, EC decision date: 27/07/2010, Last updated: 30/07/2010formulations are based on tiamulin hydrogen fumarate in a variety of … Key facts Tiamutintiamulin hydrogen fumarateV-A-042 Article 34 … formulations are based on tiamulin hydrogen fumarate in a variety of … -
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Opinion/decision on a Paediatric investigation plan (PIP): Terguride (hydrogenmaleate)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002015-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 02/12/2016, Last updated: 30/01/2017, Compliance check: XKey facts Terguride (hydrogenmaleate) Immunology-Rheumatology-TransplantationP/0349/2016EMEA-002015-PIP01-16 … specific waiver for terguride (hydrogenmaleate) (EMEA-002015-PIP01-16) PDF … specific waiver for terguride (hydrogenmaleate) (EMEA-002015-PIP01-16) in … -
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Orphan designation: Lisuride hydrogen maleate for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 13/05/2011, Positive, Last updated: 09/04/2013Lisuride hydrogen maleate Overview On 13 May … UG, Germany, for lisuride hydrogen maleate for the treatment … information to show that lisuride hydrogen maleate might be of potential … -
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Orphan designation: Hydrocortisone hydrogen succinate for: Prevention of bronchopulmonary dysplasia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022Hydrocortisone hydrogen succinate Overview This medicine … Hydrocortisone hydrogen succinate … -
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Human medicine European public assessment report (EPAR): Clopidogrel BGR (previously Zylagren)
clopidogrel (as hydrogen sulfate), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 17, Authorised, Last updated: 11/03/2020
substance clopidogrel (as hydrogen sulfate) International non-proprietary … Zylagren) clopidogrel clopidogrel (as hydrogen sulfate … -
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Opinion/decision on a Paediatric investigation plan (PIP): acetylsalicylic acid, clopidogrel hydrogen sulfate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001463-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/07/2013, Last updated: 03/09/2013, Compliance check: Xacetylsalicylic acid clopidogrel hydrogen sulfate Cardiovascular diseasesP/0179/2013EMEA-001463-PIP01-13 … product-specific waiver for clopidogrel (hydrogen sulphate) / acetylsalicylic … specific waiver for clopidogrel (hydrogen sulphate) / acetylsalicylic … -
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Opinion/decision on a Paediatric investigation plan (PIP): clopidogrel hydrogen sulfate, acetylsalicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001257-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 25/04/2012, Last updated: 24/05/2012, Compliance check: XKey facts clopidogrel hydrogen sulfate acetylsalicylic acid … specific waiver for clopidogrel (hydrogen sulfate) / acetyl salicylic … specific waiver for clopidogrel (hydrogen sulfate), acetyl salicylic … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021citrate monohydratePotassium hydrogen carbonate Overview On 20 … monohydrate and potassium hydrogen carbonate (also known as … potassium citrate) and potassium hydrogen carbonate (also known as … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of cystinuria
Date of designation: 09/01/2020, Positive, Last updated: 06/04/2021citrate monohydratePotassium hydrogen carbonate Overview On 9 January … monohydrate and potassium hydrogen carbonate (also known as … citrate monohydrate Potassium hydrogen carbonate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated, Potassium hydrogen carbonate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001357-PIP01-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules
Decision date: 07/12/2018, Last updated: 19/02/2019, Compliance check: V, 15/11/2019citrate monohydrated Potassium hydrogen carbonate Therapeutic area … monohydrated / Potassium hydrogen carbonate for treatment … monohydrated / Potassium hydrogen carbonate for treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Plavix, clopidogrel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000049-PIP01-07-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral formulation, Film-coated tablet
Decision date: 26/11/2010, Last updated: 20/12/2010, Compliance check: V, 10/12/2010el clopidogrel clopidogrel hydrogen sulfate … -
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)
acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 02/08/2022
75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic … 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic … acid acetylsalicylic acid clopidogrel hydrogen sulfate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated, potassium hydrogen carbonate (ADV7103)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001535-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules
Decision date: 17/07/2018, Last updated: 27/11/2018, Compliance check: Xcitrate monohydrated potassium hydrogen carbonate (ADV7103) Uro-nephrologyP/0214/2018EMEA-001535-PIP01-13-M01 … monohydrated / potassium hydrogen carbonate (ADV7103) (EMEA-001535-PIP01-13-M01 … monohydrated / potassium hydrogen carbonate for treatment of …