164 results
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Human medicine European public assessment report (EPAR): Drovelis
drospirenone, estetrol monohydrate, Contraceptives, Oral
Date of authorisation: 19/05/2021, Revision: 4, Authorised, Last updated: 31/03/2023medicine. active substances drospirenone and estetrol monohydrate … medicine. active substances , drospirenone (a progestogen) and estetrol … present during pregnancy, and drospirenone is a hormone with similar … -
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Human medicine European public assessment report (EPAR): Lydisilka
estetrol monohydrate, drospirenone, Contraceptives, Oral
Date of authorisation: 19/05/2021, Revision: 3, Authorised, Last updated: 31/03/2023medicine. active substances drospirenone and estetrol monohydrate … medicine. active substances , drospirenone (a progestogen) and estetrol … present during pregnancy, and drospirenone is a hormone with similar … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lydisilka, Estetrol, drospirenone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001332-PIP01-12-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 31/12/2021, Last updated: 28/03/2023, Compliance check: XActive substance Estetrol drospirenone Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … investigation plan for estetrol / drospirenone (Lydisilka), (EMEA-001332-PIP01-12-M05 … investigation plan for estetrol / drospirenone (Lydisilka), (EMEA-001332-PIP01-12-M05 … -
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Opinion/decision on a Paediatric investigation plan (PIP): drospirenone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001495-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 20/05/2016, Last updated: 27/07/2016, Compliance check: V, 23/03/2018Active substance drospirenone Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … paediatric investigation plan for drospirenone (EMEA- 001495-PIP01-13-M01 … paediatric investigation plan for drospirenone (EMEA- 001495-PIP01-13-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): drospirenone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001495-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XActive substance drospirenone Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … product specific waiver for drospirenone (Slinda and associated names … product specific waiver for drospirenone (Slinda and associated names),(EMEA- 001495-PIP02-21 … -
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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: 11/01/2013substances, ethinylestradiol and drospirenone, which are derived from natural … derived from oestrogen and drospirenone is derived from progesterone … 24+4 (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) PDF … -
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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: 03/01/2013substances, ethinylestradiol and drospirenone, which are derived from natural … derived from oestrogen and drospirenone is derived from progesterone … names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) PDF … -
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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: 03/07/2008ethinylestradiol and 3 mg of drospirenone. The MAH submitted variation … Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol: Background … Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol BACKGROUND … -
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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: 11/01/2013substances, ethinylestradiol and drospirenone, which are derived from natural … derived from oestrogen and drospirenone is derived from progesterone … 24+4 (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) PDF … -
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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: 03/07/2008ethinylestradiol and 3 mg of drospirenone. The MAH submitted variation … Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol: Background … About this medicineBelanette drospirenoneethinyl estradiolAbout this procedureCHMP/332403/08 … -
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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-Gynaecology-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 … Drospirenone / ethinylestradiol bethadex … Word - Decision and Opinion drospirenone - ethinylestradiol 00014… … -
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Referral: Combined hormonal contraceptives
desogestrel, gestodene, norgestimate, etonogestrel, drospirenone, dienogest, chlormadinone, nomegestrol, norelgestromin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/01/2014, Last updated: 31/01/2014drospirenone, gestodene or desogestrel … Women using a CHC containing drospirenone, gestodene or desogestrel … desogestrel, dienogest, drospirenone, etonogestrel, gestodene … -
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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-Gynaecology-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 … Drospirenone / ethinylestradiol, betadex … granting of a waiver for drospirenone / ethinylestradiol, betadex … -
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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-Gynaecology-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 … Drospirenone / ethinylestradiol, betadex … Word - Decision and Opinon drospirenone 000475-PIP01-08 for publi… … -
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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-Gynaecology-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 … Drospirenone / ethinylestradiol, betadex … granting of a waiver for drospirenone / ethinylestradiol, betadex … -
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National expert: Norbert Benda, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.63 KB | PDF
- Curriculum Vitae - 201.02 KB | PDF
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Combined hormonal contraceptives
Last updated: 22/11/2013drospirenone, gestodene …
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 April 2012
CHMP, Last updated: 20/04/2012Ethinylestradiol-Drospirenone 24+4 ethinylestradiol / drospirenone Bayer PLC Yvidually ethinylestradiol … Yvidually ethinylestradiol / drospirenone Bayer B.V … -
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Press release: PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks
PRAC, Last updated: 11/10/2013progestogens gestodene, desogestrel, drospirenone, with between 9 and 12 cases … gestodene, desogestrel, drospirenone, with between 9 and 12 cases … desogestrel, dienogest, drospirenone, etonogestrel, gestodene … -
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Press release: Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation
CHMP, Last updated: 22/11/2013drospirenone, gestodene or desogestrel … Women using a CHC containing drospirenone, gestodene or desogestrel … desogestrel, dienogest, drospirenone, etonogestrel, gestodene … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021
CHMP, Last updated: 26/03/2021active substances estetrol and drospirenone, received positive opinions … -
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Press release: European Medicines Agency starts safety review of Diane 35 and its generics
PRAC, Last updated: 08/02/2013chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene … desogestrel, dienogest, drospirenone, etonogestrel, gestodene … -
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Press release: Benefits of Diane 35 and its generics outweigh risks in certain patient groups - PRAC recommendation endorsed by CMDh
CMDh, Last updated: 30/05/2013gestodene, desogestrel or drospirenone. You should be aware that … gestodene, desogestrel or drospirenone. • You should be aware … gestodene, desogestrel or drospirenone. Data on the risk of arterial … -
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Human medicine European public assessment report (EPAR): Zoely
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011, Revision: 23, Authorised, Last updated: 16/02/2023contraceptive pill containing drospirenone and ethinyl estradiol for … contraceptive pill containing drospirenone and ethinyl estradiol for … contraceptive pill containing drospirenone and ethinyl estradiol for … -
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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: 05/08/2013gestodene, desogestrel or drospirenone. You should be aware that … gestodene, desogestrel or drospirenone. Data on the risk of arterial … gestodene, desogestrel or drospirenone. • You should be aware …