Is Mecasermin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Mecasermin, including Increlex 40 mg per 4 ml (10 mg/ml, Solution for injection, SAR 2518.40).

Is Mecasermin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mecasermin: Increlex.

Are there safety signals or safety updates for Mecasermin?

MHRA: 1 entry (latest 2020-01-27).

Active substance

Mecasermin

SFDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Increlex 40 mg per 4 ml	10 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 2518.40	Biological · Prescription	IPSEN PHARMA	Valid

Indications — CHI Daman Drug Formulary

CHILD GROWTH HORMONE DEFICIENCY

EMA European Union — centrally authorised medicines

Increlex Esteve Pharmaceuticals, S.A. · Authorised · authorised 2 Aug 2007 · ATC H01AC03

Therapeutic indication (EMA)

For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD). Severe primary IGFD is defined by: height standard deviation score ? -3.0 and; basal insulin-like growth factor-1 (IGF-1) levels below the 2.5th percentile for age and gender and; growth hormone (GH) sufficiency; exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
INCRELEX	02509733	10 MG / ML	SOLUTION · SUBCUTANEOUS	ESTEVE PHARMACEUTICALS S.A.

Safety signals and safety-related labeling changes

MHRA 27 Jan 2020 Mecasermin (Increlex▼): risk of benign and malignant neoplasia
Cases of benign and malignant neoplasms have been observed among children and adolescents who received treatment with mecasermin. Do not use mecasermin in children or adolescents with active or suspected neoplasia or with any condition or medical history that increases the risk of benign or malignant neoplasia.

All safety entries for mecasermin →

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.