20275 results
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Human medicine European public assessment report (EPAR): Filgrastim Hexal
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,
, Revision: 23, Authorised, Last updated: 04/10/2023
Filgrastim Hexal Agranulocytosis Leukopenia Leukocyte Disorders Hematologic … on the European Medicines Agency website. European public … responsible for preparing the Agency's opinions on questions concerning … -
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Withdrawn application: Ibandronic Acid Hexal
ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011Ibandronic Acid Hexal: Withdrawn application … On 21 July 2011, Hexal AG officially notified the Committee … authorisation for Ibandronic Acid Hexal, for the prevention of skeletal … -
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Human medicine European public assessment report (EPAR): Temozolomide Hexal
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,
, Revision: 17, Withdrawn, Last updated: 27/02/2023
Temozolomide Hexal Cancer Neuroectodermal … details Name Temozolomide Hexal Agency product number EMEA/H/C/001127 … Marketing-authorisation holder Hexal AG Revision 17 Date of issue … -
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Human medicine European public assessment report (EPAR): Rivastigmine Hexal
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 15, Authorised, Last updated: 21/06/2023Rivastigmine Hexal Nervous System Diseases Central … EPAR). What is Rivastigmine Hexal? Rivastigmine Hexal is a medicine containing … company that makes Exelon has agreed that its scientific data … -
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Human medicine European public assessment report (EPAR): Clopidogrel Hexal
clopidogrel, Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/07/2009,, Revision: 2, Withdrawn, Last updated: 26/07/2012
Clopidogrel Hexal Peripheral Vascular Diseases Acute … details Name Clopidogrel Hexal Agency product number EMEA/H/C/001139 … Website www.ema.europa.eu An agency of the European Union … -
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Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal (updated)
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,, Revision: 24, Authorised, Last updated: 21/11/2023
Epoetin Alfa Hexal Female Urogenital Diseases Female … alfa Overview Epoetin Alfa Hexal is a medicine used for the … defective). Epoetin Alfa Hexal is used when patients are … -
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013Diclofenac-containing medicines … majority new safety advice for diclofenac-containing medicines that are given … by the European Medicines Agency's Pharmacovigilance Risk Assessment … -
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Referral: Diclofenac epolamine 50 mg tablets
diclofenac, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 22/09/2016, Last updated: 10/10/2016Diclofenac epolamine 50 mg tablets … 2016, the European Medicines Agency completed an arbitration … authorisation of the medicine diclofenac epolamine (50 mg tablets … -
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Referral: Diclofenac Sodium Spray Gel 4%
diclofenac sodium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 18/01/2019, Last updated: 14/02/2019Diclofenac Sodium Spray Gel 4 … 2018, the European Medicines Agency completed a review of Diclofenac Sodium Spray Gel 4% following … regarding its authorisation. The Agency concluded that the benefits … -
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Referral: Diotop capsules
diclofenac, omeprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 31/01/2019, Last updated: 15/02/20192018, the European Medicines Agency completed a review of Diotop … regarding its authorisation. The Agency concluded that the benefits … is already controlled by diclofenac and omeprazole, the two active … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac (sodium)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002132-PIP01-17, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: XKey facts Pennsaid Diclofenac (sodium) PainP/0203/2017EMEA-002132-PIP01-17 … granting a waiver in all age groups for all conditions … product specific waiver for diclofenac (sodium) (Pennsaid), (EMEA-002132-PIP01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): diclofenac, Levomenthol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001536-PIP01-13, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Gel
Decision date: 24/01/2014, Last updated: 20/02/2014, Compliance check: XActive substance diclofenac Levomenthol Therapeutic area … granting a waiver in all age groups for all conditions … European Medicines Agency decision P/0027/2014 of 24 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac sodium, thiocolchicoside
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001558-PIP01-13, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 07/03/2014, Last updated: 16/04/2014, Compliance check: XMuscoplus Active substance Diclofenac sodium thiocolchicoside Therapeutic … granting a waiver in all age groups for all conditions … EMA/53679/2014 European Medicines Agency decision P/0056/2014 of … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac sodium, omeprazole
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/117/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified release capsule
Decision date: 07/07/2010, Last updated: 29/07/2010, Compliance check: XKey facts Diclofenac sodium omeprazole Immunology-Rheumatology-TransplantationP/117/2010P/117/2010 … granting a waiver in all age groups for all conditions … P/117/2010: European Medicines Agency decision of 7 July 2010 on … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac (sodium), capsaicin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001861-PIP01-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Gel
Decision date: 20/05/2016, Last updated: 18/07/2016, Compliance check: XKey facts Diclofenac (sodium) capsaicin PainP/0142/2016EMEA-001861-PIP01-15 … granting a waiver in all age groups for all conditions … product specific waiver for diclofenac (sodium) / capsaicin (EMEA-001861-PIP01-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac sodium, thiocolchicoside
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001558-PIP02-14, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous patch
Decision date: 25/11/2014, Last updated: 12/12/2014, Compliance check: XKey facts Diclofenac sodium thiocolchicoside PainP/0311/2014EMEA-001558-PIP02-14 … granting a waiver in all age groups for all conditions … product specific waiver for diclofenac sodium / thiocolchicoside … -
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Opinion/decision on a Paediatric investigation plan (PIP): diclofenac, orphenadrine (citrate) (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-003337-PIP01-22, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Solution for infusion, Tablet
Decision date: 31/01/2023, Last updated: 09/11/2023, Compliance check: XKey facts diclofenac orphenadrine (citrate) PainP/0036/2023EMEA-003337-PIP01-22 … granting a waiver in all age groups for all conditions … product specific waiver for diclofenac / orphenadrine (citrate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac (sodium), thiocolchicoside
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002580-PIP01-19, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2019, Last updated: 03/04/2020, Compliance check: XActive substance Diclofenac (sodium) thiocolchicoside … granting a waiver in all age groups for all conditions … Diclofenac (sodium) thiocolchicoside … -
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Opinion/decision on a Paediatric investigation plan (PIP): cyanocobalamin, Diclofenac (potassium), pyridoxine (hydrochloride), Thiamine (hydrochloride)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation; Pain
PIP number: EMEA-003292-PIP01-22, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 02/12/2022, Last updated: 24/10/2023, Compliance check: XKey facts cyanocobalamin Diclofenac (potassium) pyridoxine (hydrochloride … granting a waiver in all age groups for all conditions … product specific waiver for diclofenac (potassium) / thiamine (hydrochloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac (sodium), Thiamine (hydrochloride), pyridoxine (hydrochloride), cyanocobalamin (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-003292-PIP02-22, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Treatment of familial Mediterranean fever
Decision date: 31/01/2023, Last updated: 09/11/2023, Compliance check: XKey facts Diclofenac (sodium) Thiamine (hydrochloride … granting a waiver in all age groups for all conditions … product specific waiver for diclofenac (sodium) / thiamine (hydrochloride … -
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Herbal medicinal product: Agni casti fructus
Vitex agnus-castus L., Agnus Castus Fruit, F: Assessment finalised, Last updated: 22/10/2018Agni casti fructus Urinary tract … monographs and preparing the Agency’s opinions on questions relating … monographs and preparing the Agency’s opinions on questions relating … -
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Herbal medicinal product: Agrimoniae herba
Agrimonia eupatoria L., Agrimony, F: Assessment finalised, Last updated: 20/02/2023Agrimoniae herba Mouth and throat disorders Skin … monographs and preparing the Agency’s opinions on questions relating … monographs and preparing the Agency’s opinions on questions relating … -
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Human medicine European public assessment report (EPAR): Thymanax
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009,
Date of refusal: 18/11/2006, Revision: 24, Withdrawn, Last updated: 08/08/2022Withdrawn Agomelatine Overview This is a summary … on the European Medicines Agency website. European public … Thymanax. It explains how the Agency assessed the medicine to … -
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Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 24, Authorised, Last updated: 08/08/2022Authorised Agomelatine Overview This is a summary … on the European Medicines Agency website. European public … Valdoxan. It explains how the Agency assessed the medicine to … -
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Human medicine European public assessment report (EPAR): Thymanax
Agomelatine, Depressive Disorder, Major
Date of refusal: 16/01/2007, Refused, Last updated: 27/07/2006Refused Agomelatine Overview On 27 July 2006 … European Medicines Agency Evaluation of Medicines … International Nonproprietary Name: Agomelatine Procedure No. EMEA/H/C/656 …