Drovelis 3 mg/14.2 mg film-coated tablets
*Company:
Gedeon Richter IrelandStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 05 March 2025
File name
Drovelis PIL.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 6 - date of revision
- Change to warnings or special precautions for use
Updated on 05 March 2025
File name
Drovelis SmPC.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 - Updated information with reference to patients with renal impairment and the paediatric population.
Section 4.8 - New subheading to include additional information with reference to the paediatric population.
Section 5.1 - Updated information under the subheading Paediatric Population.
Section 5.2 - Average peak plasma concentration after intake of Drovelis updated from 17.9 to 18 ng/mL 0.5-2 hours after single ingestion.
Updated information under the subheading Renal Impairment
Updated information under the subheading Paediatric Population.
Section 10 - Updated to 30/1/2025
Updated on 17 July 2024
File name
Drovelis SmPC Jul 2024.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.2 and 5.2 - Updated to include additional information under the subheading Hepatic Impairment.
Updated on 11 January 2024
File name
Drovelis_UK_IE_MT__PIL_completed.pdf
Reasons for updating
- Change to date of revision
File name
pcard_DROVELIS_UK-IE-MT_K31053-12_29430790.pdf
Reasons for updating
- Add New Doc
File name
CHC prescriber-checklist - IE Gedeon Richter FINAL.pdf
Reasons for updating
- Add New Doc
Updated on 05 July 2023
File name
Drovelis 3 mg-14,2 mg fctbl_PIL_en_EU-1-21-1547-001-004.pdf
Reasons for updating
- New PIL for new product
Updated on 05 July 2023
File name
Drovelis 3 mg-14,2 mg fctbl_SmPC_en_EU-1-21-1547-001-004.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Gedeon Richter Ireland
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Address:
4045 Kingswood Road, Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
medinfo.uk@gedeonrichter.euTelephone:
00 44 207 604 8800Medical Information Direct Line:
00 44 207 604 8806