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RegisterCrushed Rivaroxaban? [Regulatives / Guidelines]
» This point of the Q&A may be confusing and may clash to what is indicated in the product specific quidelines of some products. An example:
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» -Ticagrelor: SmPC of Ticagrelor indicates that the tablets can be crushed to a fine powder mixed with 1/2 glass of water and administered. It also allows to administer via nasogastric tube. However the Product specific guideline here ask only for fasting study.
I just realized the same may apply to Rivaroxaban: According to point 3.6 of EMA's Q&A regulators could ask for a BE study on crushed tablets while the Product Specific Guideline ask "only" for fast (10 mg) and fed (20 mg) studies.
Could we expect a new version of this Product Specific Guideline?
Thanks,
»
» -Ticagrelor: SmPC of Ticagrelor indicates that the tablets can be crushed to a fine powder mixed with 1/2 glass of water and administered. It also allows to administer via nasogastric tube. However the Product specific guideline here ask only for fasting study.
I just realized the same may apply to Rivaroxaban: According to point 3.6 of EMA's Q&A regulators could ask for a BE study on crushed tablets while the Product Specific Guideline ask "only" for fast (10 mg) and fed (20 mg) studies.
Could we expect a new version of this Product Specific Guideline?
Thanks,
Complete thread:
- EMA Q&A vs EMA Product Specific guideline Averroes 2017-10-04 12:01 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Crushed Rivaroxaban?Averroes 2018-01-09 12:00
- Crushed Rivaroxaban? lukamar 2018-08-20 12:24
- specific BE study with administration of crushed/disintegrated tablet wienui 2019-12-03 18:20
- Crushed Rivaroxaban? lukamar 2018-08-20 12:24
- Crushed Rivaroxaban?Averroes 2018-01-09 12:00
Ing. Helmut Schütz