Tuzulby

Active substance: methylphenidate

methylphenidate hydrochloride

Centralised EU authorisationActive

Marketing holder: Neuraxpharm Pharmaceuticals S.L.

Verified 2026-10-09 · EMA

Analogues in other countries

Source: EMA
Countries with the substance registered: 2
Countries with import data: 11

Composition

methylphenidate hydrochloride

Analogues by country

Products with the same active substance registered in other countries.

Country	Products
US 245	CONCERTA TABLET, EXTENDED RELEASE · METHYLPHENIDATE HYDROCHLORIDE 27 mg/1 50458-588 Janssen Pharmaceuticals, Inc. CONCERTA TABLET, EXTENDED RELEASE · METHYLPHENIDATE HYDROCHLORIDE 36 mg/1 50458-586 Janssen Pharmaceuticals, Inc. CONCERTA TABLET, EXTENDED RELEASE · METHYLPHENIDATE HYDROCHLORIDE 54 mg/1 50458-587 Janssen Pharmaceuticals, Inc. CONCERTA TABLET, EXTENDED RELEASE · METHYLPHENIDATE HYDROCHLORIDE 18 mg/1 50458-585 Janssen Pharmaceuticals, Inc. Cotempla XR-ODT TABLET, ORALLY DISINTEGRATING · METHYLPHENIDATE 25.9 mg/1 70165-300 Neos Therapeutics Brands, LLC All products in this country (245)

Country

Products

US 245

CONCERTA
TABLET, EXTENDED RELEASE · METHYLPHENIDATE HYDROCHLORIDE 27 mg/1
50458-588
Janssen Pharmaceuticals, Inc.
CONCERTA
TABLET, EXTENDED RELEASE · METHYLPHENIDATE HYDROCHLORIDE 36 mg/1
50458-586
Janssen Pharmaceuticals, Inc.
CONCERTA
TABLET, EXTENDED RELEASE · METHYLPHENIDATE HYDROCHLORIDE 54 mg/1
50458-587
Janssen Pharmaceuticals, Inc.
CONCERTA
TABLET, EXTENDED RELEASE · METHYLPHENIDATE HYDROCHLORIDE 18 mg/1
50458-585
Janssen Pharmaceuticals, Inc.
Cotempla XR-ODT
TABLET, ORALLY DISINTEGRATING · METHYLPHENIDATE 25.9 mg/1
70165-300
Neos Therapeutics Brands, LLC

All products in this country (245)

Import and control

Import by country

United Arab Emiratespermit requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table1a_sea:methylphenidate:AE · valid from 2026-04-01 · verified 2026-10-08
Germanypermit requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table2_europe:methylphenidate:DE · valid from 2026-04-01 · verified 2026-10-08
Spainpermit requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table2_europe:methylphenidate:ES · valid from 2026-04-01 · verified 2026-10-08
Georgiapermit requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table2_europe:methylphenidate:GE · valid from 2026-04-01 · verified 2026-10-08
Indonesiaprohibitedfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table1a_sea:methylphenidate:ID · valid from 2026-04-01 · verified 2026-10-08
Japanpermit requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table1b_eastasia:methylphenidate:JP · valid from 2026-04-01 · verified 2026-10-08
South Koreapermit requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table1b_eastasia:methylphenidate:KR · valid from 2026-04-01 · verified 2026-10-08
Sri Lankaprescription requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table2_europe:methylphenidate:LK · valid from 2026-04-01 · verified 2026-10-08
Singaporepermit requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table1a_sea:methylphenidate:SG · valid from 2026-04-01 · verified 2026-10-08
Thailandpermit requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table1a_sea:methylphenidate:TH · valid from 2026-04-01 · verified 2026-10-08
Vietnampermit requiredfrom any country
Source: Article “Which medicines cannot be brought in: table for 15 countries” · record table1b_eastasia:methylphenidate:VN · valid from 2026-04-01 · verified 2026-10-08

Control by country

United StatescontrolledSchedule: CII
Source: openFDA NDC · record 01a1208c-2993-78cd-b3ad-4c797b86597d,01a1208c-2ba6-77ab-ac25-380268b68a05,01a1208c-3bd9-7963-90d8-dd6b2a78ad38,01a1208c-48da-74d5-8681-19db064abfa1,01a1208c-4b09-7ee8-a584-1168d62bdc21;count=245 · valid from 2026-10-09 · verified 2026-10-09