The reference to rice hulls should be removed from the SPC.
Se suprimirá del RCP la referencia a las cáscaras de arroz.
The wording of the SPC was updated to reflect this.
El texto del RCP se actualizó para reflejar ese cambio.
Please refer to the SPC for further details.
For further details, refer to the SPC.
Relevant information relating to the supporting studies should be added to the SPC.
Se debe añadir al RCP información relevante sobre los estudios de apoyo.
Italy could have accepted the application but with revised wording in the SPC.
Italia podría haber aceptado la solicitud si se modificaba el texto del RCP.
However, several amendments to the SPC were introduced.
No obstante, se introdujeron varias modificaciones en el RCP.
Several amendments to various sections of the SPC were introduced.
Se han introducido cambios en algunas secciones del RCP.
The effect on serology is adequately reflected in the SPC.
El efecto en la serología se refleja debidamente en el RCP.
The indication and the associated posology were removed from the harmonised SPC.
Se suprimieron del RCP armonizado la indicación y la posología relacionada.
The SPC reflects the results of the various safety studies.
En el RCP se recogen los resultados de diversos estudios de seguridad.
Other sections of the SPC were harmonised accordingly.
Otras secciones del RCP se armonizaron en consecuencia.
This wording was considered in the proposed harmonised SPC.
Se analizó el texto del RCP armonizado propuesto.