Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Bayer AG, 51368, Leverkusen, Germany
Adempas 0.5 mg film-coated tablets.
Adempas 1 mg film-coated tablets.
Adempas 1.5 mg film-coated tablets.
Adempas 2 mg film-coated tablets.
Adempas 2.5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). 0.5 mg tablet: white, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 0.5 and an “R” on the other side. 1 mg tablet: pale yellow, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1 and an “R” on the other side. 1.5 mg tablet: yellow-orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 1.5 and an “R” on the other side. 2 mg tablet: pale orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 2 and an “R” on the other side. 2.5 mg tablet: red-orange, round, biconvex tablets of 6 mm, marked with the Bayer cross on one side and 2.5 and an “R” on the other side. |
Adempas 0.5 mg film-coated tablets: Each film-coated tablet contains 0.5 mg of riociguat.
Adempas 1 mg film-coated tablets: Each film-coated tablet contains 1 mg of riociguat.
Adempas 1.5 mg film-coated tablets: Each film-coated tablet contains 1.5 mg of riociguat.
Adempas 2 mg film-coated tablets: Each film-coated tablet contains 2 mg of riociguat.
Adempas 2.5 mg film-coated tablets: Each film-coated tablet contains 2.5 mg of riociguat.
Excipient with known effect:
Adempas 0.5 mg film-coated tablets: Each 0.5 mg film-coated tablet contains 37.8 mg lactose (as monohydrate).
Adempas 1 mg film-coated tablets: Each 1 mg film-coated tablet contains 37.2 mg lactose (as monohydrate).
Adempas 1.5 mg film-coated tablets: Each 1.5 mg film-coated tablet contains 36.8 mg lactose (as monohydrate).
Adempas 2 mg film-coated tablets: Each 2 mg film-coated tablet contains 36.3 mg lactose (as monohydrate).
Adempas 2.5 mg film-coated tablets: Each 2.5 mg film-coated tablet contains 35.8 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Riociguat |
Riociguat is a stimulator of soluble guanylate cyclase (sGC), an enzyme in the cardiopulmonary system and the receptor for nitric oxide (NO). Riociguat restores the NO-sGC-cGMP pathway and leads to increased generation of cGMP. |
| List of Excipients |
|---|
|
Tablet core: Cellulose microcrystalline Film-coat: Hydroxypropylcellulose |
PP/Aluminium foil blister.
Pack sizes: 42, 84, 90 or 294 film-coated tablets.
Not all pack sizes may be marketed.
Bayer AG, 51368, Leverkusen, Germany
Adempas 0.5 mg film-coated tablets:
EU/1/13/907/001
EU/1/13/907/002
EU/1/13/907/003
EU/1/13/907/016
Adempas 1 mg film-coated tablets:
EU/1/13/907/004
EU/1/13/907/005
EU/1/13/907/006
EU/1/13/907/017
Adempas 1.5 mg film-coated tablets:
EU/1/13/907/007
EU/1/13/907/008
EU/1/13/907/009
EU/1/13/907/018
Adempas 2 mg film-coated tablets:
EU/1/13/907/010
EU/1/13/907/011
EU/1/13/907/012
EU/1/13/907/019
Adempas 2.5 mg film-coated tablets:
EU/1/13/907/013
EU/1/13/907/014
EU/1/13/907/015
EU/1/13/907/020
Date of first authorisation: 27 March 2014
Date of latest renewal: 18 January 2019
| Drug | Countries | |
|---|---|---|
| ADEMPAS | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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