396 results
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Opinion/decision on a Paediatric investigation plan (PIP): purified diphtheria toxoid, Purified Tetanus Toxoid, Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)], Inactivated poliomyelitis vaccine (Vero) – Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett), Purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: Purified diphtheria toxoid / Purified tetanus toxoid / Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)] / Inactivated p..., Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection (in a pre-filled syringe), Suspension for injection in a vial
Decision date: 31/03/2009, Last updated: 18/05/2009, Compliance check: V, 18/09/2009polyribosylribitol phosphate capsular polysaccharide of Haemophilus … polyribosylribitol phosphate capsular polysaccharide of Haemophilus … polyribosylribitol phosphate capsular polysaccharide of Haemophilus … -
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National expert: Helena Mollby, Medical Products Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 18.06 KB | PDF
Vitae PERSONAL INFORMATION Helena Mollby WORK EXPERIENCE June 2016 … Mollby 2020-12-30 Classified as … declaration of interests I, Helena Mollby Organisation/Company: Medical … -
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National expert: Norbert Moller, Federal Office of Consumer Protection and Food Safety (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.09 KB | PDF
Vitae PERSONAL INFORMATION Norbert Moller WORK EXPERIENCE January … Moller 2020-12-18 Classified as … of interests I, Norbert Moller Organisation/Company: Federal … -
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National expert: Marion Moller, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 16.51 KB | PDF
Vitae PERSONAL INFORMATION Marion Moller WORK EXPERIENCE November … Marion Moller … Marion Moller … -
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National expert: Wim Van Molle, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 27.55 KB | PDF
Vitae PERSONAL INFORMATION Wim Van Molle WORK EXPERIENCE May 2008 … Libert, C., Takahashi, N., Van Molle, W. & Fiers, W. Receptor selective … 190, 1994. Libert, C., Van Molle, W., Brouckaert, P. & Fiers … -
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National expert: Kirstine Moll Harboe, Danish Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 18.36 KB | PDF
Vitae PERSONAL INFORMATION Kirstine Moll Harboe WORK EXPERIENCE December … prednisolone treatment]. Moll Harboe K1, Midtgaard H, Wewer … of interests I, Kirstine Moll Harboe Organisation/Company … -
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Human medicine European public assessment report (EPAR): Granpidam
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,
, Revision: 4, Authorised, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Grastofil
filgrastim, Neutropenia
Date of authorisation: 17/10/2013,
, Revision: 13, Authorised, Last updated: 16/10/2020
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Human medicine European public assessment report (EPAR): Repaglinide Accord
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 22/12/2011,, Revision: 6, Authorised, Last updated: 30/09/2020
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Human medicine European public assessment report (EPAR): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 5, Authorised, Last updated: 22/07/2020
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Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,
, , Revision: 5, Authorised, Last updated: 25/05/2020
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National expert: Kai-Uwe Riedel, Medical Products Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 18.92 KB | PDF
electrons to Rhodobacter capsulatus nitrogenase. Eur.J.Biochem … purple bacterium Rhodobacter capsulatus. J Mol Microbiol Biotechnol … nitrogen fixation in Rhodobacter capsulatus: identification of new anf … -
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Human medicine European public assessment report (EPAR): Palonosetron Accord (updated)
Palonosetron, Vomiting, Nausea, Cancer
Date of authorisation: 26/05/2016,, Revision: 4, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 5, Authorised, Last updated: 17/02/2021
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Human medicine European public assessment report (EPAR): Levetiracetam Accord (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 12, Authorised, Last updated: 10/02/2021
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Human medicine European public assessment report (EPAR): Zercepac (updated)
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,, , Revision: 2, Authorised, Last updated: 09/02/2021
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Human medicine European public assessment report (EPAR): Bortezomib Accord (updated)
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 8, Authorised, Last updated: 02/02/2021
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Human medicine European public assessment report (EPAR): Entecavir Accord
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 3, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Tigecycline Accord
Tigecycline, Soft Tissue Infections, Intraabdominal Infections, Bacterial Infections, Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Authorised, Last updated: 24/04/2020
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Human medicine European public assessment report (EPAR): Fampridine Accord
Fampridine, Multiple Sclerosis
Date of authorisation: 24/09/2020,, Authorised, Last updated: 02/10/2020
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Human medicine European public assessment report (EPAR): Pramipexole Accord
pramipexole dihydrochloride monohydrate, Parkinson Disease, Restless Legs Syndrome
Date of authorisation: 29/09/2011,, Revision: 10, Authorised, Last updated: 11/12/2020
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 1, Authorised, Last updated: 24/11/2020
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 5, Authorised, Last updated: 05/11/2020
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Human medicine European public assessment report (EPAR): Zoledronic Acid Accord
zoledronic acid monohydrate, Hypercalcemia, Fractures, Bone, Cancer
Date of authorisation: 16/01/2014,, Revision: 7, Authorised, Last updated: 26/10/2020
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 11, Authorised, Last updated: 21/10/2020
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