384 results
Keyword Ethinylestradiol Remove keyword
-
List item
Referral: Perlinring and associated names
etonogestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/10/2018, EC decision date: 18/12/2018, Last updated: 21/01/2019Perlinring (etonogestrel / ethinylestradiol vaginal ring) in the EU … etonogestrel ethinylestradiol … -
List item
Referral: Seasonique and associated names
levonorgestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/11/2014, EC decision date: 12/01/2015, Last updated: 29/01/2015containing levonorgestrel and ethinylestradiol and then for the remaining … takes tablets containing only ethinylestradiol. Levonorgestrel (a progestogen … Levonorgestrel (a progestogen) and ethinylestradiol (an oestrogen) are both hormones … -
List item
Referral: Yaz 24+4
ethinylestradiol, drospirenone, associated names: Ethinylestradiol-Drospirenone 24+4, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 03/07/2012, Last updated: 11/01/2013procedure for Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4. The Agency's Committee … granted. What are Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4? Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 are combined contraceptive … Yaz 24+4 and Ethinylestradiol-Drospirenone Q&A 6 July 2012 EMA/257547/2012 … -
List item
Referral: Yvidually
ethinylestradiol, drospirenone, associated names: Flexyess, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 28/09/2012, Last updated: 03/01/2013contains two active substances, ethinylestradiol and drospirenone, which are … produced in the ovaries: ethinylestradiol is derived from oestrogen … Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 … -
List item
Referral: Yasminelle
drospirenone, ethinylestradiol, 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: 03/07/2008contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone … Name (INN): Drospirenone + Ethinylestradiol: Background information PDF … Name (INN): Drospirenone + Ethinylestradiol BACKGROUND INFORMATION … -
List item
Referral: Rigevidon
levonorgestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/01/2005, EC decision date: 10/05/2005, Last updated: 08/06/2005levonorgestrel (LNG) and 30μg ethinylestradiol (EE2). A Marketing Authorisation … INN): levonorgestrel and ethinylestradiol: Background information PDF … idon, INN-levonorgestrel and ethinylestradiol European Medicines … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): levonorgestrel, ethinylestradiol
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-000829-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/07/2010, Last updated: 26/08/2010, Compliance check: XKey facts levonorgestrel ethinylestradiol Endocrinology, -gynacology-fertility-metabolismP/135/2010EMEA-000829-PIP01-09 … substance(s): Levonorgestrel Ethinylestradiol Condition(s): Contraception … levonorgestrel ethinylestradiol … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): drospirenone, ethinylestradiol bethadex clathrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Drospirenone / ethinylestradiol bethadex clathrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 23/02/2009, Last updated: 23/04/2009, Compliance check: XDrospirenone / ethinylestradiol bethadex clathrate Endocrinology … associated names drospirenone ethinylestradiol bethadex clathrate Endocrinology … gynacology-fertility-metabolismP/24/2009Drospirenone / ethinylestradiol bethadex clathrate Film-coated … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Prasterone, levonorgestrel, ethinylestradiol (new)
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-002960-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 08/09/2021, Last updated: 11/01/2023, Compliance check: XPrasterone levonorgestrel ethinylestradiol Endocrinology, -gynacology-fertility-metabolismP/0359/2021EMEA-002960-PIP02-21 … prasterone / levonorgestrel / ethinylestradiol (EMEA- 002960-PIP02-21) PDF … prasterone / levonorgestrel / ethinylestradiol (EMEA- 002960-PIP02-21) in … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): drospirenone, L-5-methyltetrahydrofolic acid, calcium salt, ethinylestradiol, betadex clathrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid, calcium salt, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 14/07/2009, Last updated: 16/09/2009, Compliance check: XDrospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic … L-5-methyltetrahydrofolic acid, calcium salt ethinylestradiol betadex clathrate Endocrinology … gynacology-fertility-metabolismP/130/2009Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): drospirenone, L-5-methyltetrahydrofolic acid, calcium salt, ethinylestradiol, betadex clathrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid, calcium salt, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 18/05/2009, Last updated: 09/07/2009, Compliance check: XDrospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic … L-5-methyltetrahydrofolic acid, calcium salt ethinylestradiol betadex clathrate Endocrinology … gynacology-fertility-metabolismP/90/2009Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): drospirenone, L-5-methyltetrahydrofolic acid, calcium salt, ethinylestradiol, betadex clathrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic acid, calcium salt, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 18/05/2009, Last updated: 09/07/2009, Compliance check: XDrospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic … L-5-methyltetrahydrofolic acid, calcium salt ethinylestradiol betadex clathrate Endocrinology … gynacology-fertility-metabolismP/89/09Drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahydrofolic … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dienogest, ethinylestradiol (as betadex clathrate), L-5-methyltetrahydrofolic acid, calcium salt
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: Dienogest / ethinylestradiol (as betadex clathrate) / L-5-methyltetrahydrofolic acid, calcium salt, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/06/2009, Last updated: 11/08/2009, Compliance check: XDienogest / ethinylestradiol (as betadex clathrate … Key facts Dienogest ethinylestradiol (as betadex clathrate) L-5-methyltetrahydrofolic … gynacology-fertility-metabolismP/121/2009Dienogest / ethinylestradiol (as betadex clathrate … -
List item
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: 11/01/2013Ethinylestradiol-Drospirenone 24+4 … procedure for Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4. The Agency's Committee … granted. What are Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4? Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 are combined contraceptive … -
List item
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- and ethinylestradiol-containing medicines … cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics … cyproterone acetate 2 mg and ethinylestradiol 35 micrograms have been approved … -
List item
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: 24/03/2017combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be … containing dienogest and ethinylestradiol should only be used to treat … at least as effective as ethinylestradiol/norgestimate and … -
List item
Etonogestrel and ethinylestradiol vaginal delivery system product-specific bioequivalence
Last updated: 01/04/2020Etonogestrel and ethinylestradiol vaginal delivery system product-specific … of the etonogestrel and ethinylestradiol vaginal delivery system 0.12m …
-
List item
Press release: Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed
Last updated: 27/01/2017combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be … combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be … containing dienogest and ethinylestradiol should only be used to treat … -
List item
Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, Revision: 27, Authorised, Last updated: 12/08/2022impairment and in women taking ethinylestradiol, an oestrogen found in hormonal … impairment and in women taking ethinylestradiol, an oestrogen found in hormonal … -
List item
Human medicine European public assessment report (EPAR): Evra
norelgestromin, ethinyl estradiol, Contraception
Date of authorisation: 22/08/2002, Revision: 25, Authorised, Last updated: 09/11/2022norelgestromin (6 mg) and ethinylestradiol (600 micrograms). How is … in Evra are two hormones, ethinylestradiol (an oestrogen) and norelgestromin … norelgestromin (a progestogen). Ethinylestradiol has been in use extensively … -
List item
Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,
, Revision: 25, Authorised, Last updated: 12/08/2022
not be used in women taking ethinylestradiol, an oestrogen found in hormonal … not be used in women taking ethinylestradiol, an oestrogen found in hormonal … -
List item
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: 03/07/2008contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone … Name (INN): Drospirenone + Ethinylestradiol: Background information PDF … names, INN- Drospirenone + Ethinylestradiol European Medicines … -
List item
News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 February 2013
PRAC, Last updated: 08/02/2013Cyproterone- and ethinylestradiol-containing medicines … -
List item
News: Pharmacovigilance Risk Assessment Committee (PRAC) invites stakeholders' feedback in review of Diane 35 and its generics
PRAC, Last updated: 12/02/2013cyproterone acetate 2 mg and ethinylestradiol 35 micrograms, the European … page for cyproterone- and ethinylestradiol-containing medicines . All data should … cyproterone acetate 2 mg / ethinylestradiol 35 micrograms), associated … -
List item
List of medicines under additional monitoring (updated)
Last updated: 25/01/2023of cyproterone-acetate / ethinylestradiol-containing medicinal products in the … of cyproterone-acetate / ethinylestradiol-containing medicinal products in the …