2812 results
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Orphan designation: Ethyl Eicosapentaenoate for: Treatment of Huntington’s disease
Date of designation: 29/12/2000, Positive, Last updated: 04/01/2006Ethyl Eicosapent soft gelatin capsules: Withdrawn application Ethyl … Ethyl Eicosapent soft gelatin capsules: Orphan designation … Ethyl Eicosapent soft gelatin capsules Ethyl Eicosapent soft gelatin … -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Withdrawn application: Ethyl Eicosapent soft gelatin capsules
date of withdrawal: 01/12/2009, Initial authorisation, Last updated: 08/12/2009Ethyl Eicosapent soft gelatin capsules: Withdrawn application … thyl Eicosapent soft gelatin capsules?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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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP04-13-M01, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 31/01/2017, Last updated: 20/03/2017, Compliance check: V, 19/10/2018Invented name Lucentis Active substance ranibizumab … EMEA- 000527-PIP04-13). What is Lucentis (ranibizumab), and how is … is it expected to work? Lucentis (ranibizumab) is a medicine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP03-13, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 06/08/2014, Last updated: 22/08/2014, Compliance check: XInvented name Lucentis Active substance ranibizumab … EMEA-000527-PIP03-13). What is Lucentis (ranibizumab), and how is … is it expected to work? Lucentis (ranibizumab) is a medicine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP02-10, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection – single-use vial, Solution for injection – single-use pre-filled syringe
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: XInvented name Lucentis Active substance ranibizumab … specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP02-10 … specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP02-10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP01-08, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection – single-use vial, Solution for injection – single-use pre-filled syringe
Decision date: 07/09/2009, Last updated: 07/12/2009, Compliance check: XInvented name Lucentis Active substance ranibizumab … specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP01-08 … specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP01-08 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP05-17, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 07/05/2018, Last updated: 22/11/2018, Compliance check: XInvented name Lucentis Active substance ranibizumab … Lucentis Lucentis ranibizumab ranibizumab ra … -
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Human medicine European public assessment report (EPAR): Lucentis (updated)
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetes Complications; Myopia, Degenerative
Date of authorisation: 22/01/2007, Revision: 42, Authorised, Last updated: 17/05/2023Lucentis Eye Diseases Retinal Diseases Retinal … Lucentis … Lucentis, INN-ranibizumab 1 … -
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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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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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National expert: María Isabel Lucena, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 39.44 KB | PDF
- Curriculum Vitae - 43.93 KB | PDF
María Isabel Lucena … María Isabel Lucena … information María Isabel Lucena Work experience … -
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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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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): Byooviz
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021,
, 
, Revision: 6, Authorised, Last updated: 14/04/2023
reference medicine for Byooviz is Lucentis. For more information on biosimilar … studies comparing Byooviz with Lucentis have shown that the active … highly similar to that in Lucentis in terms of structure, purity … -
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Human medicine European public assessment report (EPAR): Ximluci
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 09/11/2022,, , Authorised, Last updated: 29/11/2022
reference medicine for Ximluci is Lucentis. For more information on A … studies comparing Ximluci with Lucentis have shown that the The substance … highly similar to that in Lucentis in terms of structure, purity … -
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Human medicine European public assessment report (EPAR): Ranivisio
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022,, , Revision: 2, Authorised, Last updated: 30/01/2023
medicine for Ranivisio is Lucentis. For more information on A … comparing Ranivisio with Lucentis have shown that the The substance … highly similar to that in Lucentis in terms of structure, purity … -
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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 Actavis (updated)
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,, Revision: 15, Authorised, Last updated: 01/06/2023
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 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 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 … 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: 14, Authorised, Last updated: 20/04/2023
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 …