411 results
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Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated virus serotype 2 encoding human aromatic L-amino acid decarboxylase
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002753-PIP01-19, Route(s) of administration: Intracerebral use, Pharmaceutical form(s): Solution for infusion
Decision date: 16/06/2020, Last updated: 09/03/2021, Compliance check: Xserotype 2 encoding human aromatic L-amino acid decarboxylase … serotype 2 (AAV2) encoding human aromatic L-amino acid decarboxylase … 2 (AAV2) encoding human aromatic L-amino acid decarboxylase … -
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Herbal medicinal product: Caryophylli floris aetheroleum
Syzygium aromaticum (L.) Merr. et L.M. Perry (syn. Eugenia caryophyllus (Spreng.) Bullock et S.G. Harrison), Clove oil, F: Assessment finalised, Last updated: 16/09/2021oil Botanical name Syzygium aromaticum (L.) Merr. et L.M. Perry … floris aetheroleum Syzygium aromaticum (L.) Merr. et L.M. Perry … -
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Herbal medicinal product: Caryophylli flos
Syzygium aromaticum (L.) Merr. et L.M.Perry (syn. Eugenia caryophyllus (Spreng.) Bullock et S.G.Harrison), Clove, F: Assessment finalised, Last updated: 16/09/2021Caryophylli flosCloveSyzygium aromaticum (L.) Merr. et L.M.Perry (syn … assessment report on Syzygium aromaticum (L.) Merill et L.M. Perry … Perry, flos and Syzygium aromaticum (L.) Merill et L.M. Perry … -
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Orphan designation: recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein, Eladocagene exuparvovec for: Treatment of aromatic L-amino acid decarboxylase deficiency
Date of designation: 18/11/2016, Positive, Last updated: 10/08/2022designation for the treatment of aromatic L-amino acid decarboxylase … carrying the gene for the human aromatic L-amino acid decarboxylase … protein for the treatment of aromatic L-amino acid decarboxylase … -
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Orphan designation: Refusal of orphan designation for the treatment of off-periods in adult patients with advanced Parkinson's disease
Date of refusal of designation: 09/09/2010, Negative, Last updated: 30/03/2012tyrosine hydroxylase gene, human aromatic L amino-acid decarboxylase … hydroxylase gene, human aromatic L amino-acid decarboxylase … tyrosine hydroxylase gene, human aromatic L amino-acid decarboxylase … -
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Polycyclic Aromatic Hydrocarbons in herbal medicinal products/traditional herbal medicinal products - Scientific guideline
Last updated: 29/06/2016Polycyclic Aromatic Hydrocarbons in herbal medicinal … Polycyclic Aromatic Hydrocarbons in herbal medicinal … flection paper on Polycyclic Aromatic Hydrocarbons in herbal medicinal …
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Human medicine European public assessment report (EPAR): Tyverb (updated)
lapatinib, Breast Neoplasms
Date of authorisation: 10/06/2008, Revision: 35, Authorised, Last updated: 10/05/2023chemotherapy); in combination with an aromatase inhibitor (another type of … a day when taken with an aromatase inhibitor. All of the tablets … together with letrozole (an aromatase inhibitor). It involved 1,286 … -
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Human medicine European public assessment report (EPAR): Verzenios
abemaciclib, Breast Neoplasms
Date of authorisation: 26/09/2018,
, Revision: 9, Authorised, Last updated: 22/02/2023
medicine, such as tamoxifen, an aromatase inhibitor or fulvestrant … medicine, such as tamoxifen, an aromatase inhibitor or fulvestrant … treatment (tamoxifen or aromatase inhibitor). After a study … -
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Human medicine European public assessment report (EPAR): Kisqali
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017, Revision: 13, Authorised, Last updated: 31/03/2023oestrogen receptors) or an aromatase inhibitor (which reduces … in combination with an aromatase inhibitor or fulvestrant … 2.5 mg letrozole or another aromatase inhibitor or with 500 mg … -
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Human medicine European public assessment report (EPAR): Afinitor
everolimus, Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms
Date of authorisation: 02/08/2009, Revision: 30, Authorised, Last updated: 27/06/2022treatments called ‘non-steroidal aromatase inhibitors’ have not worked … cancer, in combination with an aromatase inhibitor, in postmenopausal … Δ4A) through the action of aromatase, an enzyme of the cytochrome … -
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Human medicine European public assessment report (EPAR): Ibrance (updated)
Palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,, Revision: 16, Authorised, Last updated: 06/06/2023
following ways: together with an aromatase inhibitor (a hormonal medicine … Ibrance and letrozole (an aromatase inhibitor) or placebo and … combination with letrozole (an aromatase inhibitor) or fulvestrant … -
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018,
, Revision: 10, Authorised, Last updated: 24/03/2023
class of medicines called aromatase inhibitors; metastatic gastric … class of medicines called aromatase inhibitors; • metastatic … -
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Human medicine European public assessment report (EPAR): Trazimera
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/07/2018,, , Revision: 11, Authorised, Last updated: 17/10/2022
class of medicines called aromatase inhibitors; metastatic gastric … class of medicines called aromatase inhibitors; • metastatic … -
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Human medicine European public assessment report (EPAR): Herceptin
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 28/08/2000, Revision: 42, Authorised, Last updated: 17/03/2023or docetaxel, or with an aromatase inhibitor; When used as an … Herceptin and anastrozole (an aromatase inhibitor) in 208 women who … or docetaxel, or with an aromatase inhibitor; When used as … -
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Human medicine European public assessment report (EPAR): Zercepac
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 27/07/2020,, , Revision: 8, Authorised, Last updated: 09/02/2023
type of medicine called an aromatase inhibitor; metastatic gastric … in combination with an aromatase inhibitor for the treatment … Administration in combination with an aromatase inhibitor In the pivotal … -
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Human medicine European public assessment report (EPAR): Ogivri
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018,, , Revision: 9, Authorised, Last updated: 30/09/2022
type of medicine called an aromatase inhibitor; metastatic gastric … in combination with an aromatase inhibitor for the treatment … Administration in combination with an aromatase inhibitor In the pivotal … -
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Human medicine European public assessment report (EPAR): Ontruzant
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 15/11/2017,, Revision: 14, Authorised, Last updated: 20/09/2022
class of medicines called aromatase inhibitors; metastatic gastric … class of medicines called aromatase inhibitors; • metastatic … -
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Referral: Femara
letrozole, associated names: Femar, Fémara, Loxifan, Article 30 referrals
Status: European Commission final decision, opinion/position date: 15/03/2012, EC decision date: 22/05/2012, Last updated: 12/06/2012Femara, letrozole, is an 'aromatase inhibitor'. This means that … action of an enzyme called 'aromatase', which is involved in the … blocking the activity of aromatase and thereby reducing the … -
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,, Revision: 19, Authorised, Last updated: 11/04/2023
class of medicines called aromatase inhibitors; metastatic gastric … class of medicines called aromatase inhibitors; metastatic … -
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Human medicine European public assessment report (EPAR): Upstaza
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, 
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, Revision: 4, Authorised, Last updated: 05/04/2023
months and older with severe aromatic L-amino acid decarboxylase … months and older with severe aromatic L-amino acid decarboxylase … -
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Referral: Arimidex
anastrozole, Article 30 referrals
Status: European Commission final decision, opinion/position date: 17/03/2011, EC decision date: 18/05/2011, Last updated: 27/07/2011group of medicines called 'aromatase inhibitors' which reduce … enzyme in the body called 'aromatase'. Decreasing the production … of medicines called ‘aromatase inhibitors’ which reduce … -
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Press release: Re-analysis of data on use of breast cancer medicine Tyverb following treatment with trastuzumab
CHMP, Last updated: 30/04/2019was used together with an aromatase inhibitor. The detected errors … Tyverb in combination with an aromatase inhibitor, whose disease … -
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Press release: No change to product information for breast cancer medicine Tyverb following re-assessment of data
CHMP, Last updated: 27/03/2020Tyverb used together with an aromatase inhibitor compared with trastuzumab … trastuzumab used with an aromatase inhibitor in patients previously … medicine was used with an aromatase inhibitor. However, in April … -
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Opinion/decision on a Paediatric investigation plan (PIP): Eladocagene exuparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002435-PIP01-18-M02, Route(s) of administration: Intracerebral use, Pharmaceutical form(s): Solution for infusion
Decision date: 17/03/2021, Last updated: 19/11/2021, Compliance check: Xindication(s) Treatment of aromatic L-amino acid decarboxylase … Condition(s): Treatment of aromatic L-amino acid decarboxylase … Condition Treatment of aromatic L-amino acid decarboxylase … -
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Opinion/decision on a Paediatric investigation plan (PIP): Zometa, zoledronic acid
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000024-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion, Concentrate for solution for infusion
Decision date: 24/06/2008, Last updated: 21/07/2008, Compliance check: V, 12/12/2008breast cancer treated with aromatase inhibitors Prevention of … breast cancer treated with aromatase inhibitors Pharmaceutical … breast cancer treated with aromatase inhibitors in o Subset(s …