EMA/PE/0000241119

Key facts

Active substance

(12m)-(1s,2s)-n-((63s,4s,z)-11-ethyl-12-(2-((s)-1-methoxyethyl)-5-(4-methylpiperazin-1-yl)pyridin-3-yl)-10,10-dimethyl-5,7-dioxo-61,62,63,64,65,66-hexahydro-11h-8-oxa-2(4,2)-thiazola-1(5,3)-indola-6(1,3)-pyridazinacycloundecaphane-4-yl)-2-methylcyclopropane-1-carboxamide

Therapeutic area

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Decision number

EMA/PE/0000241119

PIP number

EMA/PE/0000241119

Pharmaceutical form(s)

All pharmaceutical forms

Condition(s) / indication(s)

Treatment of pancreatic cancer

Route(s) of administration

All routes of administration

Contact for public enquiries

Revolution Medicines Inc. E-mail: [email protected] Tel.: +1 844 273 8633

Decision type

P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision date

16/05/2025

Compliance check done

No

Decision

EMA/PE/0000241119 : EMA decision of 16 May 2025 on the granting of a product specific waiver for (12M)-(1S,2S)-N-((63S,4S,Z)-11-ethyl-12-(2-((S)-1-methoxyethyl)-5-(4-methylpiperazin...

Adopted

Reference Number:

EMADOC-1700519818-2116009

English (EN) (241.12 KB - PDF)

First published:

07/07/2026

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