Spevigo 450 mg concentrate for solution for infusion
*Company:
Boehringer Ingelheim LimitedStatus:
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 10 December 2024
File name
S11a-EU-SPC-4.pdf
Reasons for updating
- 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
Annual renewal of the conditional MA; no updates were made to the SmPC text, only date of revision
Updated on 11 October 2024
File name
X-0006G -PIL - Spevigo.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 11 October 2024
File name
S11a-EU-SPC-3 medicines.ie.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 4.1 Therapeutic indications: now includes the treatment of flares in GPP in adolescents as monotherapy
Section 4.2 Posology and method of administration: updated to include reference to the pre-filled syringe; revised dosing information for adolescents including adolescents weighing ≥ 30 and < 40 kg; new heading ‘Special populations’.
Section 4.4 Special warnings and precautions for use: update to information relating to Hypersensitivity and infusion-related reactions; Re-treatment; Immunisations
Section 4.5 Interaction with other medicinal products and other forms of interaction: updated wording
Section 4.6: Fertility, pregnancy and lactation: updated wording for breastfeeding
Section 4.8 Undesirable effects: update to summary and Table 1; update to wording on infections; text on immunogenicity removed; text on paediatric populations added.
Section 4.9 Overdose: additional text
Section 5.1 Pharmacodynamic properties: main changes, update to Table 2 for Effisayil 1; inclusion of information from Effasayil 2; text on immunogenicity added; paediatric population statement updated.
Section 5.2 Pharmacokinetic properties: updated information
Section 6.6 Special precautions for disposal and other handling: update to the handling instructions
Section 10 Date of revision of the text: updated to 25 September 2024
Updated on 01 November 2023
File name
Spevigo pil text MAA.pdf
Reasons for updating
- New PIL for new product
Updated on 01 November 2023
File name
S11-EU-SPC-2.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)