SAI - Detailed view

FEMOSTON Tabl 2/10 mg 28 Stk

Drug

Name

Femoston, comprimés

Field of application

Hormonsubstitution nach der Menopause

ATC

G03FB08 - DYDROGESTERONE AND ESTROGEN

07.08.6. – combinations

Use

HAM – Human medicine

pharmaceutical form

TAB – Tablet

Remedy code

S – synthetic products for human use

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

53128

Initial registration date

12/17/1996

Expiry date

12/31/9999

Dosage strength

Name

Femoston 2/10 mg, comprimés

Field of application

Substitution hormonale après la ménopause

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680531280336

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

28 tablet(s)

Package code

033

Authorisation status

Z – approved

Declaration

Component I)

Active substance

2 mg estradiolum
2.06 mg estradiolum hemihydricum

Excipient

118.2 mg lactosum monohydricum
hypromellosum
maydis amylum
silica colloidalis anhydrica
magnesii stearas
hypromellosum
talcum
macrogolum 400
E 171
E 172 (rubrum)
E 172 (flavum)
E 172 (nigrum)

Component II)

Active substance

2 mg estradiolum
2.06 mg estradiolum hemihydricum
10 mg dydrogesteronum

Excipient

109.4 mg lactosum monohydricum
hypromellosum
maydis amylum
silica colloidalis anhydrica
magnesii stearas
hypromellosum
talcum
macrogolum 400
E 171
E 172 (flavum)