Oedien 2 mg - 0,03 mg film-coat. tabl.

Country: Belgium

Language: English

Source: AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

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Active ingredient:

Dienogest 2 mg (white tablet); Ethinylestradiol 0,03 mg (white tablet); Placebo (pink tablet)

Available from:

Laboratoires Bailleul S.A.

ATC code:

G03FA15

INN (International Name):

Dienogest; Ethinylestradiol; Placebo

Dosage:

2 mg - 0,03 mg

Pharmaceutical form:

Film-coated tablet

Composition:

Dienogest 2 mg; Ethinylestradiol 0.03 mg; Placebo

Administration route:

Oral use

Therapeutic area:

Dienogest and Estrogen; G03AA16 Dienogest and Ethinylestradiol

Product summary:

CTI code: 512231-01 - Pack size: 28 (7 + 21) - Commercialisation status: NO - Delivery mode: Medical prescription; CTI code: 512231-02 - Pack size: 3 x 28 (21 + 7) - Commercialisation status: YES - FMD code: 03660398502264 - CNK code: 3734860 - Delivery mode: Medical prescription; CTI code: 512231-03 - Pack size: 6 x 28 (21 + 7) - Commercialisation status: YES - FMD code: 03660398502271 - CNK code: 3734852 - Delivery mode: Medical prescription; CTI code: 512231-04 - Pack size: 13 x 28 (21 + 7) - Commercialisation status: YES - FMD code: 03660398502288 - CNK code: 3734878 - Delivery mode: Medical prescription

Authorization status:

Commercialised: Yes

Authorization date:

2017-06-26

Documents in other languages

Patient Information leaflet Patient Information leaflet German 13-12-2023
Patient Information leaflet Patient Information leaflet French 13-12-2023
DHPC DHPC French 25-08-2022
Patient Information leaflet Patient Information leaflet Dutch 13-12-2023
DHPC DHPC Dutch 25-08-2022