PROPESS 10 mg vaginal delivery system
*Company:
Ferring Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 January 2022
File name
ie-smpc-propess-Nov 21.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 updated - restrict usage
Section 4.2, 4.3, 4.4 updated to strengthen wording
section 4.8 updated to add uterine hyperstimulation and complications
Updated on 09 March 2020
File name
Propess SPC_In line with license dated 06 03 2020.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to SPC Section 2 - Addition of "and releases approximately 0.3 mg/hour dinoprostone over a 24-hour period"
Update to SPC Section 3 - Addition of dimentions of vaginal delivery system
Update to SPC Section 5.1 - Change to Pharmacotherapeutic group
Update to SPC Section 6.1 - Change name of excipient 'polyethylene glycol' to 'macrogol'
Updated on 12 July 2019
File name
Propess SPC_in line with licence dated 15 01 2019.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)