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.

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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.

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

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