Is Selpercatinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Selpercatinib, including Retevmo (40 mg, Capsule, SAR 11768.60); Retevmo (80 mg, Capsule, SAR 23537.15).

Is Selpercatinib approved by the US FDA?

Drugs@FDA lists 3 application product lines for Selpercatinib, including RETEVMO (Prescription); RETEVMO (Prescription); RETEVMO (Prescription).

Is Selpercatinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Selpercatinib: Retsevmo.

Are there safety signals or safety updates for Selpercatinib?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2026-07-14).

Active substance

Selpercatinib

SFDA 3
US FDA 3
EMA 1
Health Canada 3
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Retevmo	40 mg	Capsule · Oral use	60 Bottle	SAR 11768.60	NCE · Prescription	Eli Lilly and Company	Valid
Retevmo	80 mg	Capsule · Oral use	60 Bottle	SAR 23537.15	NCE · Prescription	Eli Lilly and Company	Valid
Retevmo	80 mg	Capsule · Oral use	120 Bottle	SAR 47074.35	NCE · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

Cervical Cancer; COLORECTAL CANCER-ADVANCED/ METASTATIC; ESOPHAGEAL CANCER; GASTRIC CANCER; MALIGNANT NEOPLASM OF THE PANCREAS; NEUROENDOCRINE TUMORS; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); OVARIAN CANCER; SOFT TISSUE SARCOMA; THYROID CANCER

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
RETEVMO	40MG; 80MG	capsule · oral	ELI LILLY AND CO	Prescription	8 May 2020
RETEVMO	40MG; 80MG; 120MG; 160MG	tablet · oral	ELI LILLY AND CO	Prescription	10 Apr 2024
RETEVMO	40MG; 80MG	capsule · oral	ELI LILLY AND CO	Prescription	10 Apr 2024

EMA European Union — centrally authorised medicines

Retsevmo Eli Lilly Nederland B.V. · Authorised · authorised 11 Feb 2021 · ATC L01EX22

Therapeutic indication (EMA)

Retsevmo as monotherapy is indicated for the treatment of adults with: advanced RET fusion positive non small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. For biomarker-based patient selection, see section 4.2. Retsevmo as monotherapy is indicated for the treatment of adults and paediatric patients 2 years of age and older with: advanced RET fusion positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate) . For biomarker-based patient selection, see section 4.2. advanced RET mutant medullary thyroid cancer (MTC) . For biomarker-based patient selection, see section 4.2. advanced RET fusion positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1). For biomarker-based patient selection, see section 4.2.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
RETEVMO	02516918	40 MG	CAPSULE · ORAL	ELI LILLY CANADA INC
RETEVMO	02516926	80 MG	CAPSULE · ORAL	ELI LILLY CANADA INC
RETEVMO	02565676	80 MG	TABLET · ORAL	ELI LILLY CANADA INC

Safety signals and safety-related labeling changes

US FDA 14 Jul 2026 RETEVMO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Jul 2026 RETEVMO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 9 Jul 2026 PRAC signal: Lymphangiectasia intestinal
Action for MAH: update of the product information: No
EMA PRAC 29 Sep 2022 PRAC signal: Hypothyroidism
Action for MAH: update of the product information: No

All safety entries for selpercatinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.