770 results
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Opinion/decision on a Paediatric investigation plan (PIP): Estradiol valerate, Dienogest
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Estradiol valerate / Dienogest, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2009, Last updated: 16/09/2009, Compliance check: XEstradiol valerate / Dienogest Endocrinology … Key facts Qlaira Estradiol valerate Dienogest Endocrinology … gynacology-fertility-metabolismP/140/2009Estradiol valerate / Dienogest Film-coated tablet … -
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Herbal medicinal product: Valerianae aetheroleum
Valeriana officinalis, Valerian essential oil, F: Assessment finalised, Last updated: 20/06/2016Valerianae aetheroleum Sleep disorders … on the medicinal uses of valerian essential oil. The Committee … herbal medicines containing valerian essential oil. What is valerian essential oil Valerian essential oil is the common … -
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Herbal medicinal product: Valerianae radix
Valeriana officinalis L., Valerian Root, F: Assessment finalised, Last updated: 28/04/2016Valerianae radix Sleep disorders and … on the medicinal uses of valerian root. The Committee on Herbal … herbal medicines containing valerian root. This summary is not … -
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Combination Herbal medicinal product: Valerianae radix and Lupuli flos
Combination: Valeriana officinalis L. and Humulus lupulus L., Valerian Root and Hop Strobile, F: Assessment finalised, Last updated: 05/02/2020Valerianae radix and Lupuli flos Sleep … on the medicinal uses of valerian root and hop strobile as … herbal medicines containing valerian root and hop strobile. This … -
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Human medicine European public assessment report (EPAR): Zoely
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011, Revision: 22, Authorised, Last updated: 16/12/2022nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow … acetate (a progestogen) and estradiol (an oestrogen Estradiol is the same as a hormone … drospirenone and ethinyl estradiol for one year (13 menstrual … -
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Human medicine European public assessment report (EPAR): Evra
norelgestromin, ethinyl estradiol, Contraception
Date of authorisation: 22/08/2002, Revision: 25, Authorised, Last updated: 09/11/2022orised norelgestrominethinyl estradiol Overview This is a summary … ethinylestradiol (EE) or with estradiol (E2). In February 2013 … Evra norelgestromin ethinyl estradiol norelgestromin ethinyl estradiol … -
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Human medicine European public assessment report (EPAR): Ioa
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 16/11/2011, Revision: 4, Withdrawn, Last updated: 26/08/2014Ioa nomegestrol acetate / estradiol This is a summary of the … nomegestrol acetate (2.5 mg) and estradiol (1.5 mg), and four yellow … acetate (a progestogen) and estradiol (an oestrogen … -
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Human medicine European public assessment report (EPAR): Ryeqo
relugolix, norethisterone acetate, estradiol hemihydrate, Leiomyoma
Date of authorisation: 16/07/2021,
, Revision: 4, Authorised, Last updated: 27/07/2022
active substances relugolix, estradiol and norethisterone acetate … active substance of Ryeqo, estradiol, is a natural sex hormone … bone density loss. However, estradiol used alone can cause hyperplasia … -
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Referral: Nomegestrol and chlormadinone
nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: European Commission final decision, opinion/position date: 01/09/2022, EC decision date: 28/11/2022, Last updated: 14/12/2022chlormadinone nomegestrol estradiol Nomegestrol acetate estradiol … -
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Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use
estradiol, associated names: Linoladiol, Linoladiol N, Linoladiol Estradiol, Estradiol Wolff, Montadiol, Article 31 referrals
Status: CMDh final position, opinion/position date: 30/01/2020, Last updated: 08/04/2020Estradiol-containing (0.01% w/w) medicinal products … for use of high-strength estradiol creams confirmed … estradiol … -
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Direct healthcare professional communication (DHPC): Risks associated with systemic exposure to estradiol creams
Active substance: estradiol, DHPC type: Referral - Article 31, Last updated: 20/02/2020with systemic exposure to estradiol creams … with systemic exposure to estradiol creams 20/02/2020 20/02/2020 … with systemic exposure to estradiol creams Key facts estradiolEMEA/H/A-31/1482VariationReferral - Article 31 Estradiol-containing (0.01% w/w) medicinal products … -
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Referral: Linoladiol N and Linoladiol HN
estradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/04/2014, EC decision date: 19/08/2014, Last updated: 11/09/2014Linoladiol N and Linoladiol HN estradiol-containing creams … Estradiol Art 31 referral_14-08_public … Linoladiol N and Linoladiol HN estradiol-containing creams A limit to the duration … -
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Referral: Cyproterone- and ethinylestradiol-containing medicines
cyproterone, ethinyl estradiol, associated names: Acnemine, Acneson, Chloe, Clairette, Cyprest, Cyprodiol, Diane 35, Dianette, Feminil, Minerva, Zyrona, Article 107i procedures
Status: European Commission final decision, opinion/position date: 29/05/2013, EC decision date: 25/07/2013, Last updated: 05/08/2013cyproterone ethinyl estradiol … -
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Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne
dienogest, ethinyl estradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/01/2017, EC decision date: 22/03/2017, Last updated: 24/03/2017dienogest ethinyl estradiol … -
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Referral: Activelle
estradiol, norethisterone acetate, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 26/06/2008, EC decision date: 11/09/2008, Last updated: 25/09/2008and associated names, estradiol 0.5mg and norethisterone … and associated names, INN-estradiol and norethisterone acetate … Non-Proprietary Name (INN): Estradiol and norethisterone acetate … -
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Referral: Ethinylestradiol-Drospirenone 24+4
ethinyl estradiol, drospirenone, associated names: Yaz 24+4, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 06/07/2012, Last updated: 11/01/2013ethinyl estradiol drospirenone … -
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Referral: Belanette
drospirenone, ethinyl estradiol, Article 5(11) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 14/12/2007, EC decision date: 17/06/2008, Last updated: 03/07/2008medicineBelanette drospirenoneethinyl estradiolAbout this procedureCHMP/332403/08 … drospirenone ethinyl estradiol … -
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Referral: Laurina
desogestrel, ethinyl estradiol, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 25/09/2003, EC decision date: 05/02/2004, Last updated: 01/03/2004medicineLaurinadesogestrelethinyl estradiolAbout this procedureCPMP/1390/04 … desogestrel ethinyl estradiol … -
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Opinion/decision on a Paediatric investigation plan (PIP): relugolix, estradiol, norethisterone acetate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002428-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 22/03/2019, Last updated: 24/06/2019, Compliance check: XActive substance Relugolix estradiol norethisterone acetate Therapeutic … relugolix estradiol … -
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Opinion/decision on a Paediatric investigation plan (PIP): relugolix, estradiol, norethisterone acetate
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002428-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: XActive substance Relugolix estradiol norethisterone acetate Therapeutic … relugolix estradiol … -
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Orphan designation: estradiol hemihydrate, Progesterone for: Bronchopulmonary dysplasia in premature neonates of less than 30 weeks of gestational age
Date of designation: 11/04/2005, Positive, Last updated: 18/11/2011estradiol hemihydrateProgesterone Overview … Melsungen AG, Germany, for estradiol hemihydrate and progesterone … medicine expected to work? Estradiol hemihydrate and progesterone … -
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Opinion/decision on a Paediatric investigation plan (PIP): Dienogest, ethinyl estradiol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002229-PIP01-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 14/04/2021, Last updated: 18/01/2022, Compliance check: XKey facts Dienogest ethinyl estradiol Endocrinology, -gynacology-fertility-metabolismP/0169/2021EMEA-002229-PIP01-17-M02 … plan for dienogest / ethinyl estradiol (EMEA-002229-PIP01-17-M02 … for dienogest / ethinyl estradiol (EMEA-002229-PIP01-17-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): 17 beta-estradiol, etonogestrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001718-PIP01-14, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 29/01/2016, Last updated: 29/03/2016, Compliance check: XKey facts 17 beta-estradiol etonogestrel Endocrinology … granting of a waiver for 17 beta-estradiol / etonogestrel (EMEA-001718-PIP01-1 … Related information 17 beta-estradiol / etonogestrel - Notification … -
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Opinion/decision on a Paediatric investigation plan (PIP): Nomegestrol acetate, 17 beta-estradiol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000250-PIP01-08-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/03/2010, Last updated: 28/07/2010, Compliance check: V, 21/05/2010Nomegestrol acetate 17 beta-estradiol Endocrinology, -gynacology-fertility-metabolismP/61/2010EMEA-000250-PIP01-08-M02 … nomegestrol acetate, 17 beta -estradiol 000250-PIP01-08-M02 for publishing.doc … nomegestrol acetate / 17 beta - estradiol (EMEA-000250-PIP01-08-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Nomegestrol acetate, 17 beta-estradiol
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000658-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/11/2009, Last updated: 23/12/2009, Compliance check: XNomegestrol acetate 17 beta-estradiol Endocrinology, -gynacology-fertility-metabolismP/230/2009EMEA-000658-PIP01-08 … nomegestrol acetate, 17beta – estradiol (EMEA-000658-PIP01-09) in … nomegestrol acetate, 17beta – estradiol (EMEA-000658-PIP01-09) in …