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Angelini Pharma S.p.A., Rom, Zweigniederlassung Zug - Ontozry 12.5 mg, Tabletten und Ontozry 25 mg, Filmtabletten

Swissmedic Registration	68051	Sequence	07
Product name	Ontozry 12.5 mg, Tabletten und Ontozry 25 mg	Description	Filmtabletten
ATC-Classification	N03AX25	ATC-Description	Cenobamate
Introduction of Sequence	19.05.2022

Composition

I) Ontozry 12.5 mg, Tablette: cenobamatum 12.5 mg, cellulosum microcristallinum, lactosum monohydricum 39.67 mg, carboxymethylamylum natricum A corresp. natrium 0.16 mg, silica colloidalis anhydrica, magnesii stearas, pro compresso. II) Ontozry 25 mg, Filmtablette: cenobamatum 25 mg, cellulosum microcristallinum, lactosum monohydricum 79.34 mg, carboxymethylamylum natricum A corresp. natrium 0.32 mg, silica colloidalis anhydrica, magnesii stearas, Überzug: poly(alcohol vinylicus), E 171, macrogolum, talcum, E 172 (flavum), E 172 (rubrum), E 132, pro compresso obducto.

Packungsbestandteile

Label

Galenic Form

Coated tablets

Active Agent	Dose	additional_information
Cenobamatum	12.5 mg	Tablette

BAG: Active Agent	Dose
Cenobamatum	25 mg

Inactive agents	Dose
Carboxymethylamylum Natricum A
Cellulosum Microcristallinum
Lactose Monohydrate	39.67 mg
Magnesii Stearas
Ontozry	12.5 mg
Pro Compresso
Silica Colloidalis Anhydrica

Label

Galenic Form

Coated tablets

Active Agent	Dose	additional_information
Cenobamatum	25 mg	Filmtablette

BAG: Active Agent	Dose
Cenobamatum	25 mg

Inactive agents	Dose	additional_information
(Flavum)
(Rubrum)
Carboxymethylamylum Natricum A
Cellulosum Microcristallinum
E 132		color.
E 171		color.
E 172		color.
Lactose Monohydrate	79.34 mg
Macrogol
Magnesii Stearas
Ontozry	25 mg
Poly(Alcohol Vinylicus)		Überzug
Pro Compresso Obducto
Silica Colloidalis Anhydrica
Talcum

Package number	Package Size	EFP	CP	Category	SL	Out of trade (MedRef)
011	2 x 14	93.33	117.90	B	SL	No

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