1252 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: EMEA-000278-PIP01-08-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in 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: Norbert Moller, Federal Office Of Consumer Protection And Food Safety (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 16.25 KB | PDF
Norbert Moller … Norbert Moller … Vitae PERSONAL INFORMATION Norbert Moller WORK EXPERIENCE January … -
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National expert: Marion Moller, Federal Institute For Drugs And Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.68 KB | PDF
Marion Moller … Marion Moller … Vitae PERSONAL INFORMATION Marion Moller WORK EXPERIENCE November … -
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National expert: Wim Van Molle, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 79.89 KB | PDF
- Curriculum Vitae - 29.09 KB | PDF
Wim Van Molle … Wim Van Molle … Vitae PERSONAL INFORMATION Wim Van Molle WORK EXPERIENCE May 2008 … -
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Human medicine European public assessment report (EPAR): Nimenrix
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 20/04/2012, Revision: 35, Authorised, Last updated: 25/05/2022contains small amounts of capsular polysaccharides (sugars from … -
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National expert: Anne-Mette Hoberg, Danish Medicines Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 19.43 KB | PDF
039;Biomarkers' Griffiths, H.R; Moller, L.; Bartosz, G.; Bast, A … preparations from Methylococcus capsulatus (Bath) comprise methanol … -
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Veterinary medicine European public assessment report (EPAR): Suprelorin
deslorelin acetate, Dogs; Ferrets
Date of authorisation: 10/07/2007, Revision: 13, Authorised, Last updated: 22/04/2020needle is shielded until the moment of implantation. In case … needle is shielded until the moment of implantation. In case … -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fe receptor human monoclonal antibody {M281)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002559-PIP03-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for infusion
Decision date: 09/09/2020, Last updated: 06/07/2021, Compliance check: Xhaemolytic aneamia Intravenous use Momenta Pharmaceuticals, Inc. E-mail … application submitted by Momenta Pharmaceuticals, Inc. on … decision is addressed to Momenta Pharmaceuticals, Inc., 301 … -
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Human medicine European public assessment report (EPAR): Caspofungin Accord
caspofungin acetate, Candidiasis; Aspergillosis
Date of authorisation: 11/02/2016,
, Revision: 6, Withdrawn, Last updated: 20/08/2021
Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona … -
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Human medicine European public assessment report (EPAR): Voriconazole Accord
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 16, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Orgovyx
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,
, Revision: 4, Authorised, Last updated: 17/08/2022
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, 
, Revision: 8, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accord
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Authorised, Last updated: 20/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Accord
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 15, Authorised, Last updated: 09/01/2023
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Human medicine European public assessment report (EPAR): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 11, Authorised, Last updated: 30/11/2022
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Human medicine European public assessment report (EPAR): Sorafenib Accord
Sorafenib tosilate, Carcinoma, Hepatocellular; Carcinoma, Renal Cell
Date of authorisation: 09/11/2022,, Authorised, Last updated: 25/11/2022
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Human medicine European public assessment report (EPAR): Teriflunomide Accord
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Authorised, Last updated: 14/11/2022
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Human medicine European public assessment report (EPAR): Zubsolv
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 8, Authorised, Last updated: 29/07/2022Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona … -
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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,, Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Granpidam
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 7, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Fampridine Accord
Fampridine, Multiple Sclerosis
Date of authorisation: 24/09/2020,, Revision: 1, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 13, Authorised, Last updated: 25/03/2022
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Human medicine European public assessment report (EPAR): Temozolomide Accord
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 22, Authorised, Last updated: 21/03/2022
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Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Revision: 2, Authorised, Last updated: 26/01/2022
Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona …