12944 results
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Orphan designation: Ethyl Eicosapentaenoate for: Treatment of Huntington’s disease
Date of designation: 29/12/2000, Positive, Last updated: 04/01/2006condition, the existence or not of alternative methods of diagnosis, prevention … ii) the existence or not of alternative methods of diagnosis, prevention … Ethyl Eicosapent soft gelatin capsules Ethyl Eicosapent soft gelatin … -
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Withdrawn application: Ethyl Eicosapent soft gelatin capsules
date of withdrawal: 01/12/2009, Initial authorisation, Last updated: 08/12/2009Ethyl Eicosapent soft gelatin capsules: Withdrawn application … thyl Eicosapent soft gelatin capsules? e ethyl eicosapent. It … Ethyl Eicosapent soft gelatin capsules expected to oms of patients … -
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Herbal medicinal product: Melaleucae aetheroleum
Melaleuca alternifolia (Maiden and Betche) Cheel, Tea-tree oil, F: Assessment finalised, Last updated: 15/03/2022branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … Tea tree oil Melaleuca alternifolia (Maiden and Betch) Cheel … branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … -
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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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Clinical efficacy and safety: blood products (including biotech alternatives)
Last updated: 11/02/2016products (including biotech alternatives) …
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Referral: Fluconazol Tiefenbacher 50mg, 100mg, 150mg, 200mg capsules, hard
fluconazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 24/07/2003, EC decision date: 01/12/2003, Last updated: 11/02/200450mg, 100mg, 150mg, 200mg capsules, hard … 50mg, 100mg, 150mg, 200mg capsules, hard … mg, 100 mg, 150 mg, 200 mg capsules, hard, INN-Fluconazole … -
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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: 15/02/2019Diotop capsules … diclofenac / omeprazole capsules) in the EU PDF icon application/pdf … About this medicineDiotop capsulesdiclofenacomeprazoleAbout this procedureEMEA/H/A-29(4)/1474 … -
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Promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU - Scientific guideline
Last updated: 26/07/2021omoting the authorisation of alternatives to antimicrobial veterinary … omoting the authorisation of alternatives to antimicrobial veterinary … promoting the authorisation of alternatives to antimicrobial veterinary …
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Press release: Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels
CMDh, Last updated: 20/12/2013be used as additional or alternative treatment to reduce high … only as an additional or alternative treatment in type IIb and … role as an additional or alternative treatment to reduce triglycerides … -
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Press release: PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels
PRAC, Last updated: 08/11/2013acipimox only as additional or alternative treatment to lower high triglyceride … acipimox only as additional or alternative treatment to lower high triglyceride … acipimox only as additional or alternative treatment to lower high triglyceride … -
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Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products - Scientific guideline
Last updated: 23/04/2009rabbit pyrogen testing by an alternative test for plasma derived medicinal … rabbit pyrogen testing by an alternative test for plasma derived medicinal … RABBIT PYROGEN TESTING BY AN ALTERNATIVE TEST FOR PLASMA DERIVED MEDICINAL …
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News: Public statement on supply of Norvir hard capsules
Last updated: 28/07/1998on supply of Norvir hard capsules … European Union (EU) as a hard capsule 100 mg and an oral solution … the manufacture of the hard capsule. The following is a summary … -
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Press release: European Medicines Agency agrees to precautionary recall of Advagraf 0.5 mg capsule batches
CHMP, Last updated: 20/10/2011recall of Advagraf 0.5 mg capsule batches … recall of Advagraf 0.5 mg capsule batches … recall of Advagraf 0.5 mg capsule batches 7 Westferry … -
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Press release: Amarin Neuroscience Ltd withdraws its marketing authorisation application for Ethyl Eicosapent Soft Capsules (ethyl eicosapent)
Last updated: 08/12/2009for Ethyl Eicosapent Soft Capsules (ethyl eicosapent … eicosapent), 500 mg soft gelatine capsules. Ethyl Eicosapent was expected … Ethyl Eicosapent Soft Gelatin Capsules and the state of the scientific … -
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Direct healthcare professional communication (DHPC): Risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations to Alkindi (hydrocortisone granules in capsules for opening)
Active substance: hydrocortisone, DHPC type: Safety signal, Last updated: 04/02/2021hydrocortisone granules in capsules for opening) Adrenal Insuffi … hydrocortisone granules in capsules for opening … hydrocortisone granules in capsules for opening) Dear … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,
, Revision: 18, Authorised, Last updated: 09/11/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … process of bone growth is altered, which causes bones to become … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zometa
zoledronic acid, zoledronic acid monohydrate, Cancer; Fractures, Bone
Date of authorisation: 20/03/2001, Revision: 36, Authorised, Last updated: 09/07/2021breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … any fractures or any spinal compression. Zometa has also been compared … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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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
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 13, Authorised, Last updated: 24/06/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 05/01/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva
zoledronic acid, Fractures, Bone; Cancer
Date of authorisation: 16/08/2012,, Revision: 14, Authorised, Last updated: 11/10/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
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Human medicine European public assessment report (EPAR): VeraSeal
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 10/11/2017, Revision: 7, Authorised, Last updated: 12/01/2023worked better than manual compression, with 76% of patients having … compared with 23% after manual compression (13 out of 57). In a second … intermittent application of compresses, swabs, use of suction devices … -
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National expert: Gaelle Weiss, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 16.8 KB | PDF
wet and dry granulation, compression, film coating, sugar coating … coating, sachet filling, capsule filling, pellets loading … Therapies (CAT) member or alternate Not a CAT member or alternate CONFIDENTIALITY UNDERTAKING In … -
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Human medicine European public assessment report (EPAR): Cresemba
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,
, Revision: 15, Authorised, Last updated: 17/01/2023
drip) into a vein and as capsules to be taken by mouth. The … dosage for the infusions and capsules are the same: 200 mg every … the infusion and the oral capsule if needed. The medicine can …