14928 results
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,
, Revision: 13, Authorised, Last updated: 12/05/2022
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) Schizophrenia Spectrum and … report (EPAR) for Aripiprazole Mylan Pharma. It explains how the Agency … on how to use Aripiprazole Mylan Pharma. For practical information … -
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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: 19, Authorised, Last updated: 22/02/2022
Clopidogrel Taw Pharma (previously Clopidogrel Mylan) Vascular Diseases Cardiovascular … Overview Clopidogrel Taw Pharma is a medicine used to prevent … attack). Clopidogrel Taw Pharma can be started between a … -
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Human medicine European public assessment report (EPAR): Pregabalin Mylan Pharma (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 25/06/2015,, Revision: 7, Withdrawn, Last updated: 26/04/2022
Pregabalin Mylan Pharma Mental Disorders Nervous … authorisation for Pregabalin Mylan Pharma has been withdrawn at the … Summary documents Pregabalin Mylan Pharma : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 25, Authorised, Last updated: 14/03/2022
previously Clopidogrel Taw Pharma) Vascular Diseases Cardiovascular … or contact your doctor or pharmacist. How does Clopidogrel Viatris … Clopidogrel Viatris Clopidogrel Mylan Pharma received a marketing authorisation … -
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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 … European Medicines Agency's Pharmacovigilance Risk Assessment Committee … -
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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 … Recommendation provided by Pharmacovigilance Risk Assessment Committee … 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 … Recommendation provided by Pharmacovigilance Risk Assessment Committee … Agency completed a review of Diclofenac Sodium Spray Gel 4% following … -
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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: 15/02/2019Recommendation provided by Pharmacovigilance Risk Assessment Committee … is already controlled by diclofenac and omeprazole, the two active … Diotop have different effects. Diclofenac is a nonsteroidal anti-inflammatory … -
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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the marketing … market exclusivity under pharmaceutical legislation (typically 10 … -
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Withdrawn application: Lacosamide Pain UCB Pharma
lacosamide, date of withdrawal: 25/09/2008, Initial authorisation, Last updated: 26/09/2008Lacosamide Pain UCB Pharma: Withdrawn application … for Lacosamide Pain UCB Pharma International non-proprietary … On 25 September 2008, UCB Pharma S.A. officially notified … -
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Human medicine European public assessment report (EPAR): Sugammadex Mylan
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/11/2021,, Authorised, Last updated: 22/11/2021
Sugammadex Mylan Protective Agents Specialty … Uses Physiological Effects of Drugs Pharmacologic Actions Neuromuscular Blocka … Sugammadex Mylan is a medicine used to reverse … -
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Orphan designation: lonapegsomatropin for: Treatment of growth hormone deficiency
Date of designation: 17/10/2019, Positive, Last updated: 17/02/2022European Commission to Ascendis Pharma Endocrinology Division A/S … Lonapegsomatropin Ascendis Pharma since 11 January 2022. Expand … Lonapegsomatropin Ascendis Pharma Lonapegsomatropin Ascendis Pharma lonapegsomatropin lonapegs … -
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Withdrawn application: Oportuzumab monatox DLRC Pharma Services
oportuzumab monatox, date of withdrawal: 20/08/2021, Initial authorisation, Last updated: 20/10/2021Oportuzumab monatox DLRC Pharma Services: Withdrawn applicati … Oportuzumab monatox DLRC Pharma Services: Withdrawal of the … Oportuzumab monatox DLRC Pharma Services (oportuzumab monatox … -
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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: XKey facts Diclofenac Levomenthol OtherP/0027/2014EMEA-001536-PIP01-13 … 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: XKey facts Muscoplus Diclofenac sodium thiocolchicoside PainP/0056/2014EMEA-001558-PIP01-13 … 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: XKey facts Diclofenac (sodium) thiocolchicoside … product specific waiver for diclofenac (sodium) / thiocolchicoside … Diclofenac (sodium) thiocolchicoside … -
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Human medicine European public assessment report (EPAR): Rivastigmine 1 A Pharma
rivastigmine, Alzheimer Disease; Dementia; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 12, Authorised, Last updated: 26/01/2022Rivastigmine 1 A Pharma Nervous System Diseases Central … or contact your doctor or pharmacist. If you want more information … What is Rivastigmine 1 A Pharma? Rivastigmine 1 A Pharma is a medicine containing … -
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Human medicine European public assessment report (EPAR): Lonapegsomatropin Ascendis Pharma
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,
, 
, Authorised, Last updated: 16/03/2022
Lonapegsomatropin Ascendis Pharma Growth and Development … Lonapegsomatropin Ascendis Pharma is a medicine that is used … Lonapegsomatropin Ascendis Pharma was designated an ‘ A medicine … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva Pharma
telmisartan, Hypertension
Date of authorisation: 03/10/2011,, Revision: 10, Authorised, Last updated: 26/10/2021
Telmisartan Teva Pharma Cardiovascular Diseases Vascular … EPAR) for Telmisartan Teva Pharma. It explains how the The committee … use for Telmisartan Teva Pharma. What is Telmisartan Teva Pharma? Telmisartan Teva Pharma is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva Pharma
docetaxel, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Date of authorisation: 21/01/2011,, Revision: 6, Withdrawn, Last updated: 21/01/2014
Docetaxel Teva Pharma Carcinoma, Non-Small-Cell … Docetaxel Teva Pharma … statement on Docetaxel Teva Pharma 7 Westferry Circus … -
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Human medicine European public assessment report (EPAR): Clopidogrel Acino Pharma
clopidogrel, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 1, Withdrawn, Last updated: 26/07/2012
Clopidogrel Acino Pharma Peripheral Vascular Diseases Stroke Myocardial … authorisation for Clopidogrel Acino Pharma has been withdrawn at the … documents Clopidogrel Acino Pharma : EPAR - Summary for the …