PV Bulletin

PRAC 6-9 July 2026: Agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata News Human Pharmacovigilance Download medicine d

PRAC agreed on new safety communications for desogestrel- and etonogestrel-containing contraceptives and the JAK inhibitor Litfulo regarding safety risks.

Primary source: View

PV Impact Brief

Urgency: HighConfidence: high

What changed

Marketing Authorisation Holders (MAHs) of desogestrel- and etonogestrel-containing medicines are required to update product information to include meningioma as a side effect and implement new contraindications. For Litfulo, a boxed warning will be added on cardiovascular issues and serious infections.

Why it matters

These changes highlight significant safety concerns that may affect prescribing behaviors and patient safety. Prompt updates to product information are crucial to ensure that healthcare professionals are aware of these new risks.

Action needed

MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.

Relevant for
Regulatory Intelligence LeadSignal Management LeadLabeling LeadQPPV
Processes impacted
Signal ManagementLabelingCountry Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Meeting Highlights
Policy status
final
Publication date
2026-07-10
Policy change
The EMA Pharmacovigilance Risk Assessment Committee (PRAC) concluded its July 2026 meeting, agreeing on new safety information for several medicines. Key decisions include the dissemination of a Direct Healthcare Professional Communication (DHPC) for desogestrel- and etonogestrel-containing contraceptives regarding the risk of meningioma, and a boxed warning update for the JAK inhibitor Litfulo (ritlecitinib) to align with other Janus kinase inhibitors.

Key changes

MAHs of desogestrel- or etonogestrel-containing medicines must update product information to include meningioma as a side effect and implement new contraindications and warnings. A DHPC will be disseminated. For Litfulo, a boxed warning on cardiovascular problems, blood clots, cancer, and serious infections will be added, and educational materials must be amended.

Affected workflows

Signal ManagementLabelingCountry Compliance

Responsible groups

Pharmacovigilance OperationsRegulatory AffairsMedical AffairsQPPV

PV impact

Marketing Authorisation Holders (MAHs) must execute safety communication plans, update Risk Management Plans (RMPs), revise product information (SmPC and Package Leaflet), and update physician educational materials where applicable.

View regulator source

Source document details

Exact policy details

New safety information on desogestrel and etonogestrel-containing contraceptives
New safety information agreed
Applies to: Desogestrel and etonogestrel-containing contraceptives
PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives · p. 1 · Medium · Source
New safety information on Litfulo
New safety information agreed
Applies to: Litfulo for treating alopecia areata
PRAC agrees new safety information on Litfulo, a medicine to treat alopecia areata · p. 1 · Medium · Source
PRAC Meeting Dates
2026-07-06 to 2026-07-09
Applies to: Dates of PRAC meeting
PRAC meeting on 06-09 July 2026 · p. 1 · High · Source
Organisational and Regulatory Matters Meeting Date
2026-07-23
Applies to: Health and safety information briefing
Organisational, regulatory and methodological matters on 23 July 2026, via teleconference · p. 1 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Jul 10, 2026

Full briefing

Practical implication

MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.

During its July 2026 meeting, the EMA PRAC concluded with new safety information for desogestrel- and etonogestrel-containing contraceptives, including the risk of meningioma. A Direct Healthcare Professional Communication (DHPC) will be disseminated, and Marketing Authorisation Holders (MAHs) must update product information to reflect these changes. Additionally, for Litfulo (ritlecitinib), a boxed warning will be added related to serious cardiovascular and oncological risks, requiring MAHs to amend safety communication and educational materials.

What changed: Marketing Authorisation Holders (MAHs) of desogestrel- and etonogestrel-containing medicines are required to update product information to include meningioma as a side effect and implement new contraindications. For Litfulo, a boxed warning will be added on cardiovascular issues and serious infections.

Why it matters: These changes highlight significant safety concerns that may affect prescribing behaviors and patient safety. Prompt updates to product information are crucial to ensure that healthcare professionals are aware of these new risks.

Practical implication: MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Labeling#Safety Signals#European Medicines Agency (EMA)#final#policy-change#firecrawl-policy-agent#Meeting Highlights

Related updates for your role

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Urgency: High

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Urgency: High

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Urgency: High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward