1125 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 - 39.33 KB | PDF
- Curriculum Vitae - 21.6 KB | PDF
Norbert Moller … Norbert Moller … Vitae Personal information Norbert Moller Work experience … -
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National expert: Marion Moller, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 23.77 KB | PDF
Marion Moller … Marion Moller … Vitae Personal information Marion Moller Work experience … -
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National expert: Wim Van Molle, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 39.73 KB | PDF
- Curriculum Vitae - 41.84 KB | PDF
Wim Van Molle … Wim Van Molle … Vitae Personal information Wim Van Molle Work experience … -
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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: 36, Authorised, Last updated: 17/07/2023contains small amounts of capsular polysaccharides (sugars from … -
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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
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Human medicine European public assessment report (EPAR): Pelgraz (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,
, Revision: 11, Authorised, Last updated: 15/09/2023
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Human medicine European public assessment report (EPAR): Voriconazole Accord
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 17, Authorised, Last updated: 14/06/2023
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Human medicine European public assessment report (EPAR): Dabigatran Etexilate Accord
Dabigatran etexilate mesilate, Venous Thromboembolism; Arthroplasty, Replacement
Date of authorisation: 26/05/2023,, Authorised, Last updated: 31/05/2023
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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): Zoledronic Acid Accord
zoledronic acid monohydrate, Hypercalcemia; Fractures, Bone; Cancer
Date of authorisation: 16/01/2014,, Revision: 9, Authorised, Last updated: 24/01/2022
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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: 7, Authorised, Last updated: 21/01/2022
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Referral: Cyklo-f
tranexamic acid, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/05/2000, EC decision date: 12/09/2000, Last updated: 27/07/2000Cyklo-f is supplied as white, capsular film coated tablets containing … 1999. Cyklo-f is supplied as white, capsular film coated tablets containing … -
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Human medicine European public assessment report (EPAR): Capecitabine Accord
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 16, Authorised, Last updated: 03/08/2023
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 14, Authorised, Last updated: 24/07/2023
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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: 5, Authorised, Last updated: 07/07/2023
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Human medicine European public assessment report (EPAR): Temozolomide Accord
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 23, Authorised, Last updated: 27/06/2023
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Human medicine European public assessment report (EPAR): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 16, Authorised, Last updated: 21/06/2023
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Human medicine European public assessment report (EPAR): Sondelbay
teriparatide, Osteoporosis
Date of authorisation: 24/03/2022,
, , Authorised, Last updated: 16/06/2022
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Human medicine European public assessment report (EPAR): Vildagliptin / Metformin hydrochloride Accord
metformin hydrochloride, vildagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 24/03/2022,, , Revision: 2, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Eptifibatide Accord
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,, Revision: 6, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Granpidam
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 14/11/2016,, Revision: 8, Authorised, Last updated: 11/04/2023
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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, Withdrawn, Last updated: 30/03/2023