19075 results
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Withdrawn application: Diractin
date of withdrawal: 23/07/2008, Initial authorisation, Last updated: 24/07/2008Diractin: Withdrawn application … Diractin, INN ketoprofen European Medicines … marketing application for Diractin International non-proprietary … -
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Referral: Ketoprofen topical
ketoprofen, associated names: Fastum, Ketum, Orudis, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 22/07/2010, EC decision date: 29/11/2010, Last updated: 28/10/2011Ketoprofen topical … procedure under Article 107 of Directive 2001/83/EC The European Medicines … safety and effectiveness of ketoprofen-containing medicines used topically … -
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Referral: Dolovet Rifen
ketoprofen, Article 33
Status: European Commission final decision, opinion/position date: 09/11/2006, EC decision date: 17/04/2007, Last updated: 07/12/201115g, each containing 2.4g ketoprofen and is authorised for the … procedure under Article 33(4) of Directive 2001/82/EC, as amended. The … the number of animals used did not allow equivalence to … -
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Referral: Ketoprofene Ethypharm LP
ketoprofen, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 29/06/2000, EC decision date: 27/12/2000, Last updated: 28/12/2000Ketoprofene Ethypharm LP … to article 10 of Council Directive 75/319/EEC as amended for … 2001 Reproduction and/or distribution of this document is authorised … -
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Opinion/decision on a Paediatric investigation plan (PIP): ketoprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001783-PIP02-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Medicated plaster
Decision date: 21/12/2015, Last updated: 02/02/2016, Compliance check: XKey facts ketoprofen PainP/0317/2015EMEA-001783-PIP02-15 … product-specific waiver for ketoprofen (EMEA-001783-PIP02-15) PDF … product specific waiver for ketoprofen (EMEA-001783-PIP02-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): ketoprofen, omeprazole
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001361-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Modified release capsule
Decision date: 03/07/2013, Last updated: 13/08/2013, Compliance check: XKey facts ketoprofen omeprazole PainP/0148/2013EMEA-001361-PIP01-12 … product-specific waiver for ketoprofen / omeprazole (EMEA-001361-PIP01-12 … product specific waiver for ketoprofen / omeprazole (EMEA-001361-PIP01-12 … -
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Press release: Idea AG withdraws its marketing authorisation application for Diractin (ketoprofen)
Last updated: 24/07/2008authorisation application for Diractin ketoprofen … authorisation for the medicine Diractin ketoprofen) 22.9 mg gel Diractin was expected to be used for … authorisation application for Diractin ketoprofen) The European Medicines … -
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Questions and Answers on ketoprofen, ketorolac and piroxicam
Last updated: 31/12/2009Questions and Answers on ketoprofen, ketorolac and piroxicam …
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Veterinary medicine European public assessment report (EPAR): Suiseng Diff/A
Clostridioides difficile toxoid A, Clostridioides difficile toxoid B, Clostridium perfringens, type A, alpha toxoid, Pigs
Date of authorisation: 07/12/2021, Authorised, Last updated: 24/01/2022Suiseng Diff/A … Suiseng Diff/A … EMEA/V/C/005596 Suiseng Diff/A (Clostridioides difficile and Clostridium perfringens … -
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Press release: European Medicines Agency confirms positive benefit-risk balance of topical formulations of ketoprofen
Last updated: 22/07/2010of topical formulations of ketoprofen … Topical ketoprofen-containing medicines (creams, gels … since 1978. The review of Ketoprofen was conducted in the context … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,
, Revision: 3, Authorised, Last updated: 12/12/2022
Dimethyl fumarate Mylan Nervous System … fumarate Mylan Nervous System Diseases Autoimmune Diseases of the Nervous System Demyelinating … System Demyelinating Autoimmune Diseases, CNS Nervous System … -
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Veterinary medicine European public assessment report (EPAR): Dicural
difloxacin, Turkeys; Dogs; Cattle; Chicken
Date of authorisation: 16/01/1998, Revision: 7, Withdrawn, Last updated: 29/10/2015Dicural … Withdrawn difloxacin Overview The marketing authorisation … marketing authorisation for Dicural has been withdrawn at the … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Neuraxpharm
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 4, Authorised, Last updated: 13/04/2023
Dimethyl fumarate Neuraxpharm Multiple … Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous … Nervous System Nervous System Diseases Immune System … -
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Human medicine European public assessment report (EPAR): Tookad
padeliporfin di-potassium, Prostatic Neoplasms
Date of authorisation: 10/11/2017,
, Revision: 6, Authorised, Last updated: 07/12/2022
Male Urogenital Neoplasms Prostatic Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Neoplasms … with 14 months in those who did not receive treatment. What … procedures on the prostate, men diagnosed with cholestasis (a liver … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Polpharma
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 3, Authorised, Last updated: 16/01/2023
Dimethyl fumarate Polpharma Nervous … Polpharma Nervous System Diseases Autoimmune Diseases of the Nervous System Demyelinating … System Demyelinating Autoimmune Diseases, CNS Multiple Sclerosis Demyelinating … -
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)
Dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, 
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, Revision: 14, Authorised, Last updated: 31/03/2023
Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) Neuroectodermal … Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron … Qarziba, INN-dinutuximab beta 30 Churchill … -
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 16, Authorised, Last updated: 20/09/2022
Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … Infections Communicable Diseases Infections Sexually Transmitted … ctions Sexually Transmitted Diseases Sexually Transmitted … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Teva
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 12/12/2022,, Authorised, Last updated: 21/12/2022
Dimethyl fumarate Teva Nervous System … fumarate Teva Nervous System Diseases Autoimmune Diseases of the Nervous System Demyelinating … System Demyelinating Autoimmune Diseases, CNS Multiple Sclerosis Immune … -
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Withdrawn application: Dimherity
dimethyl fumarate, date of withdrawal: 22/02/2022, Initial authorisation, Last updated: 03/11/2022Dimherity: Withdrawn application … Dimherity: Withdrawal of the marketing … marketing authorisation of Dimherity dimethyl fumarate) Sandoz GmbH withdrew … -
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Veterinary medicine European public assessment report (EPAR): Innovax-ND-IBD
Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus, Chicken; Embryonated chicken eggs
Date of authorisation: 22/08/2017, Revision: 5, Authorised, Last updated: 04/11/2021Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant … Innovax-ND-IBD (avian Newcastle disease, infectious bursal disease and Marek’s disease vaccine (live recombinant … -
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 12, Authorised, Last updated: 15/09/2022
Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … Infections Communicable Diseases Infections Sexually Transmitted … ctions Sexually Transmitted Diseases Sexually Transmitted … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Accord
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 15/02/2023,, Authorised, Last updated: 22/02/2023
Dimethyl fumarate Accord Demyelinating … Accord Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous … Nervous System Nervous System Diseases Demyelinating … -
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Summary of opinion: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022Dimethyl fumarate Accord: Pending … initial authorisation) Dimethyl fumarate Accord dimethyl fumarate On 15 December … for the medicinal product Dimethyl fumarate Accord, intended … -
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Veterinary medicine European public assessment report (EPAR): Vectra 3D
dinotefuran, pyriproxyfen, permethrin, Dogs
Date of authorisation: 04/12/2013, Revision: 7, Authorised, Last updated: 21/02/2022Authorised dinotefuran, permethrin, and pyriproxyfen … medicine. active substances : dinotefuran, pyriproxyfen and permethrin … solution in applicators of five different strengths for use on dogs of … -
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Veterinary medicine European public assessment report (EPAR): Ultifend ND IBD
Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant, Embryonated chicken eggs; Chicken
Date of authorisation: 20/04/2021, Authorised, Last updated: 21/09/2021Authorised Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant … Ultifend ND IBD (Newcastle disease, infectious bursal disease and Marek’s disease vaccine (live recombinant …