12298 results
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001914-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/06/2016, Last updated: 26/08/2016, Compliance check: XKey facts Olmesartan medoxomil rosuvastatin calcium Cardiovascular … product specific waiver for olmesartan medoxomil) / rosuvastatin (calcium … product specific waiver for olmesartan medoxomil) / rosuvastatin (calcium … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001538-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … for amlodipine (besilate) / olmesartan medoxomil) (EMEA-001538-PIP01-13) PDF … for amlodipine (besilate) / olmesartan medoxomil) (EMEA-001538-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001852-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/11/2015, Last updated: 07/01/2016, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … product specific waiver for olmesartan medoxomil / amlodipine (besilate) (EMEA-001852-PIP01-15 … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/228/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/226/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/227/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, hydrochlorothiazide, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002104-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/07/2017, Last updated: 24/07/2017, Compliance check: XActive substance Olmesartan medoxomil hydrochlorothiazide Amlodipine … product specific waiver for olmesartan medoxomil / amlodipine (besilate … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
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Human medicine European public assessment report (EPAR): Edarbi
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011, Revision: 10, Authorised, Last updated: 17/03/2022Authorised azilsartan medoxomil Overview This is a summary … active substance azilsartan medoxomil. It is available as tablets … substance in Edarbi, azilsartan medoxomil, is an ‘angiotensin-II-receptor … -
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Human medicine European public assessment report (EPAR): Ipreziv
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011,
, Revision: 4, Withdrawn, Last updated: 19/12/2014
Withdrawn azilsartan medoxomil Overview The marketing authorisation … gt;IprezivEMEA/H/C/002517Azilsartan medoxomilazilsartan medoxomilHypertensionC09CA09 This medicine is under additional … for Ipreziv (azilsartan medoxomil) in the European Union (EU … -
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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): Edarbi, Azilsartan medoxomil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000237-PIP01-08-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules for oral suspension
Decision date: 03/12/2021, Last updated: 16/02/2023, Compliance check: XActive substance Azilsartan medoxomil Therapeutic area Cardiovascular … investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M10 … investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Azilsartan medoxomil, chlortalidone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001294-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/10/2012, Last updated: 27/11/2012, Compliance check: XKey facts Azilsartan medoxomil chlortalidone Cardiovascular … specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294 … specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294-PIP01-12 … -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014Actavis captopril imidapril zofenopril candesartan delapril telmisartan aliskiren moexipril enalapril valsartan fosinopril irbesartan perindopril quinapril ramipril eprosartan olmesartan trandolapril losartan azilsartan lisinopril spirapril benazepril cilazapril telmisartan hydrochlorothiazide telmisartan telmisartan telmisartan telmisartan amlodipine telmisartan amlodipine telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide amlodipine valsartan hydrochlorothiazide amlodipine … -
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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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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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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021candesartan, irbesartan, losartan, olmesartan, valsartan) Questions … candesartan, irbesartan, losartan, olmesartan, valsartan) EMA/86733/2021 … candesartan, irbesartan, losartan, olmesartan, valsartan) EMA/86733/2021 … -
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National expert: Thomas Sudhop, Federal Institute For Drugs And Medical Devices (updated)
- Declaration of interests - 80.02 KB | PDF
- Curriculum Vitae - 34.38 KB | PDF
Therapies (CAT) member or alternate Not a CAT member or alternate CONFIDENTIALITY UNDERTAKING In … -
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Press release: Valsartan: review of impurities extended to other sartan medicines
CHMP, Last updated: 21/09/2018irbesartan, losartan and olmesartan. Like valsartan, these active … irbesartan, losartan and olmesartan. Like valsartan, these active … Candesartan, irbesartan, losartan, olmesartan and valsartan belong to a … -
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News: Nitrosamines: EMA aligns recommendations for sartans with those for other medicines
CHMP, Last updated: 13/11/2020candesartan, irbesartan, losartan, olmesartan and valsartan, which belong … -
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National expert: Miguel-Angel Macia, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 22.52 KB | PDF
Committee on Drug Safety, Spain alternate member of the Pharmacovigilance … Prescribing Patterns of Codeine and Alternative Medicines in Children in … Martin-Serrano G, Macia MA, Montero D. Olmesartan for the prevention or delay … -
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Press release: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
Last updated: 15/10/2018candesartan, irbesartan, losartan, olmesartan and valsartan, which belong … -
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Press release: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
Last updated: 19/11/2018irbesartan, losartan and olmesartan. The review is being carried …