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Medicines
Spain
Cyproterone

AEMPS 2011

Cyproterone, Ethinyl estradiol

Diane 35 Comprimidos Recubiertos

2 mg + 0,035 mg comprimido recubiertoSpainWithdrawnAuthorised 3 Nov 2011

Open in the registerAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

This page is kept for reference and is not offered to search engines.

In other countries

The same active substances on other registers, the same brand first.

Diane 35Brazil · Bayer S.A.Same brand
Diane 35Brazil · Uniao Quimica Internacional LtdaSame brand
Diane-35Canada · 2 MG + 35 MCG · Tablet · Bayer INCSame brand
Diane-35 obložene tableteCroatia · obložena tableta · Bayer d.o.o., Radnička cesta 80, Zagreb, HrvatskaSame brand
DianeItaly · Compressa rivestita · Farmed S.R.L.Same brand
DianeItaly · Compressa rivestita · GMM Farma S.R.L.Same brand

More with the same substance on this register

DIANE DIARIO 2 mg/0,035 mg COMPRIMIDOS RECUBIERTOSCyproterone + Ethinyl estradiol · 2 mg + 0,035 mg · comprimido recubiertoSpain
ACETATO DE CIPROTERONA/ETINILESTRADIOL GINESERVICE 2 mg/0,035 mg/COMPRIMIDOS RECUBIERTOS EFGCyproterone + Ethinyl estradiol · 2 mg + 0,035 mg · comprimido recubierto

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

DianeItaly · Compressa rivestita · Bayer S.P.A.

Same brand

🇷🇸Diane®-35Serbia · 2mg+0.035mg · obložena tableta · Bayer D.O.O. BeogradSame brand

🇷🇸Diane®-35Serbia · 2mg+0.035mg · obložena tableta · Bayer D.O.O. BeogradSame brand

🇸🇦Diane-35 TabSaudi Arabia · BAYER WEIMAR GmbH UND CO. KGSame brand

🇸🇦Diane-35 TabSaudi Arabia · Bayer WeimarSame brand

🇸🇬Diane-35 TabletSingapore · 2 mg + 0.035 mg · tablet, sugar coated · Bayer (South East Asia) Pte LTDSame brand

🇹🇼Diane-35 S.C. TabletsTaiwan · 糖衣錠 · 台灣拜耳股份有限公司Same brand

🇨🇦Amb-Cyproterone Acetate / Ethinyl EstradiolCanada · 2 MG + 0.035 MG · Tablet · Ambicare Pharmaceuticals INC.Same form

🇨🇦Cléo -35Canada · 2 MG + 0.035 MG · Tablet · Altius Healthcare INCSame form

🇭🇷Axira 35 filmom obložene tableteCroatia · filmom obložena tableta · Mibe Pharmaceuticals d.o.o., Zavrtnica 17, Zagreb, HrvatskaSame form

🇳🇱Cyproteronacetaat/Ethinylestradiol Xiromed 2 mg/0,035 mg, omhulde tablettenNetherlands · Omhulde tablet · Medical Valley Invest ABSame form

🇳🇱Ethinylestradiol 0,035 mg /Cyproteronacetaat 2 mg, omhulde tablettenNetherlands · Omhulde tablet · Stragen FranceSame form

🇳🇿GinetNew Zealand · Tab 2 mg with ethinyloestradiol 35 mcg and 7 inert tabsSame form

🇳🇿GinetNew Zealand · Tab 2 mg with ethinyloestradiol 35 mcg and 7 inert tabletsSame form

🇸🇬Estelle-35 TabletSingapore · 2 mg + 0.035 mg · tablet, film coated · Apex Pharma Marketing Pte. LTD.Same form

🇧🇷acetato de ciproterona + etinilestradiolBrazil · União Química Farmacêutica Nacional S/ASame substance

🇹🇼Nortin F.C. TabletsTaiwan · 膜衣錠 · 盛弘醫藥股份有限公司Same substance

Packs

Pack	Code	Status
DIANE 35 COMPRIMIDOS RECUBIERTOS, 21 comprimidos	685366

Documents

The official texts, at the regulator.

Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substances: Cyproterone, Ethinyl estradiol
Strength: 2 mg + 0,035 mg
Dosage form: comprimido recubierto
Route: vía oral
Register: Spain (AEMPS)
Status: Withdrawn
Status in the register: Revocado
Authorised: 3 Nov 2011
Registration: 8507020
Marketing authorisation holder: Berlifarma Especialidades Farmaceuticas Lda.
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica

🇪🇸SpainWithdrawn

AEMPSACETATO DE CIPROTERONA/ETINILESTRADIOL SANDOZ 2 mg/ 0.035 mg COMPRIMIDOS RECUBIERTOS EFGCyproterone + Ethinyl estradiol · 2 mg + 0,035 mg · comprimido recubierto🇪🇸SpainWithdrawn

AEMPSGYNEPLEN 2 mg/0,035 mg COMPRIMIDOS RECUBIERTOS CON PELICULACyproterone + Ethinyl estradiol · 0,035 mg + 2 mg · comprimido recubierto con película🇪🇸SpainWithdrawn

AEMPSDiane 35 Comprimidos RecubiertosCyproterone + Ethinyl estradiol · 2 mg + 0,035 mg · comprimido recubierto con película🇪🇸SpainWithdrawn