722 results
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Withdrawn application: Ibandronic Acid Hexal
ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011Ibandronic Acid Hexal: Withdrawn application … Ibandronic Acid Hexal: Withdrawal of the marketing … authorisation) Ibandronic Acid Hexal ibandronic acid On … -
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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, Revision: 17, Withdrawn, Last updated: 27/02/2023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 … Temozolomide Hexal … statement Temozolomide Hexal (temozolomide) Withdrawal … -
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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: 21, Authorised, Last updated: 10/02/2023
Filgrastim Hexal Agranulocytosis Leukopenia Leukocyte … EPAR). What is Filgrastim Hexal? Filgrastim Hexal is a solution for injection … million units). Filgrastim Hexal is a ‘ A medicine that … -
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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: 14, Authorised, Last updated: 13/10/2022Rivastigmine Hexal Nervous System Diseases Central … EPAR). What is Rivastigmine Hexal? Rivastigmine Hexal is a medicine containing … be used for Rivastigmine Hexal (‘informed consent’ … -
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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Date of authorisation: 28/07/2009,, Revision: 2, Withdrawn, Last updated: 26/07/2012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 … Clopidogrel Hexal … Public statement Clopidogrel Hexal (clopidogrel) Withdrawal … -
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Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal
epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer
Date of authorisation: 27/08/2007,, Revision: 22, Authorised, Last updated: 09/10/2019
Epoetin Alfa Hexal Female Urogenital Diseases Female … Epoetin Alfa Hexal … dossier The applicant Hexal Biotech Forschungs GmbH submitted … -
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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 … New safety advice for diclofenac … EMA/592685/2013 New safety advice for diclofenac New measures aim to minimise … -
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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 … authorisation of the medicine diclofenac epolamine (50 mg tablets … France and Slovakia. What is 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 … Agency completed a review of Diclofenac Sodium Spray Gel 4% following … marketing authorisation. What is Diclofenac Sodium Spray Gel 4 Diclofenac Sodium Spray Gel 4% contains … -
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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: 15/02/2019is already controlled by diclofenac and omeprazole, the two active … Diotop have different effects. Diclofenac is a nonsteroidal anti-inflammatory … acid the stomach makes. Both diclofenac and omeprazole have been … -
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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 … product specific waiver for diclofenac (sodium) (Pennsaid), (EMEA-002132-PIP01 … product specific waiver for diclofenac (sodium) (Pennsaid), (EMEA-002132-PIP01-17 … -
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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 of a waiver for diclofenac / levomenthol (EMEA-001536-PIP01-13 … granting of a waiver for diclofenac / levomenthol (EMEA-001536-PIP01-13 … -
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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 … product specific waiver for diclofenac (sodium) / capsaicin (EMEA-001861-PIP01-15 … 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 … product specific waiver for diclofenac sodium / thiocolchicoside … paediatric investigation plan: Diclofenac sodium/thiocolchicoside for … -
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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 … product specific waiver for diclofenac sodium / thiocolchicoside … product specific waiver for diclofenac sodium / thiocolchicoside … -
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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 … product specific waiver for diclofenac sodium / omeprazole (EMEA-000820-PIP01-09 … product specific waiver for diclofenac sodium / omeprazole (EMEA-000820-PIP01-09 … -
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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 … Diclofenac (sodium) thiocolchicoside … -
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Press release: Hexal AG withdraws its marketing authorisation application for Ibandronic acid Hexal (ibandronic acid)
Last updated: 27/07/2011Hexal AG withdraws its marketing … application for Ibandronic acid Hexal (ibandronic acid … Hexal AG withdraws its marketing … -
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Referral: Methylphenidate Hexal
methylphenidate hydrochloride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 09/10/2013, Last updated: 05/12/2013Methylphenidate Hexal … medicine Methylphenidate Hexal. The Agency's Committee for … benefits of Methylphenidate Hexal outweigh its risks, and the … -
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Referral: Alendronate HEXAL
alendronic acid (as sodium alendronate trihydrate), Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/01/2007, EC decision date: 13/04/2007, Last updated: 20/08/2007Alendronate HEXAL … decision Overview Alendronate HEXAL and associated names, 10 … post-menopausal osteoporosis. Hexal A/S submitted applications … -
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Referral: Lansoprazol HEXAL 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/06/2005, EC decision date: 15/09/2005, Last updated: 15/09/2005Lansoprazol HEXAL 15 mg and 30 mg … decision Overview Lansoprazol HEXAL (lansoprazole) is a proton … Authorisation for Lansoprazol HEXAL (15 mg and 30 mg) was previously … -
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News: Is diclofenac a threat to European vultures?
CVMP, Last updated: 12/09/2014Is diclofenac a threat to European vultures … veterinary medicines containing diclofenac to vultures and other necrophagous … Diclofenac - Art. 30(3) - Consultation … -
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Press release: Diclofenac use in animals poses a risk to European vultures
CVMP, Last updated: 12/12/2014Diclofenac use in animals poses a risk … at risk due to residues of diclofenac if they feed on carcasses … be exposed to residues of diclofenac in the EU and, for each scenario … -
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Press release: New safety advice for diclofenac – CMDh endorses PRAC recommendation
CMDh, Last updated: 28/06/2013New safety advice for diclofenac – CMDh endorses PRAC recomm … majority new safety advice for diclofenac-containing medicines that are given … that the effects of systemic diclofenac on the heart and circulation … -
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Press release: PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors
PRAC, Last updated: 14/06/2013cardiovascular precautions for diclofenac as for selective COX-2 inhibi … cardiovascular precautions for diclofenac as for selective COX-2 inhibi … cardiovascular precautions for diclofenac as for selective COX-2 inhibitors …