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Medicines
Saudi Arabia
Isotretinoin

SFDA

Isotretinoin

Roaccutane 10MG Caps

Saudi ArabiaAuthorised

Ask Osler about it

On this page

In other countries
Sources and licences

This entry comes from a historical list and may no longer be current.

In other countries

The same active substances on other registers, the same brand first.

Roaccutane 10 mg meke kapsuleCroatia · kapsula, meka · CHEPLAPHARM Registration GmbH, Weiler Straβe 5 E, Lörrach, NjemačkaSame brand
ROACCUTANE 10 mgRomania · 10mg · caps. moi · Roche Romania S.R.L.Same brand
ROACCUTANE CAPSULE 10 mgSingapore · 10 mg · capsule, liquid filled · Zuellig Pharma Pte. LTD.Same brand
ROACCUTANE CAPSULE 20 mgSingapore · 20 mg · capsule, liquid filled · Zuellig Pharma Pte. LTD.Same brand
IsotanArgentina · 20 MG · cápsula blanda · Oxapharma S.A.Same form
Absorica LDCanada · 8 MG · Capsule · Sun Pharmaceutical Industries Limited

More with the same substance on this register

Curacne 10MG Soft Gelatin CapsuleIsotretinoinSaudi ArabiaAuthorised
Curacne 20MG Soft Gelatin CapsuleIsotretinoinSaudi ArabiaAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Same form

🇨🇦Absorica LDCanada · 32 MG · Capsule · Sun Pharmaceutical Industries LimitedSame form

🇨🇦Absorica LDCanada · 24 MG · Capsule · Sun Pharmaceutical Industries LimitedSame form

🇪🇸Acnemin 10 MG Capsulas Blandas EfgSpain · 10 mg · cápsula blanda · Laboratorios Vinas S.A.Same form

🇪🇸Acnemin 20 MG Capsulas Blandas EfgSpain · 20 mg · cápsula blanda · Laboratorios Vinas S.A.Same form

🇪🇸DERCUTANE 10 mg CAPSULAS BLANDASSpain · 10 mg · cápsula blanda · Industrial Farmaceutica Cantabria S.A.Same form

🇭🇷Izotretinoin Bonifarm 10 mg meke kapsuleCroatia · Kapsula, meka · Bonifarm d.o.o., Ulica Aleksandra Hondla 2/11, Zagreb, HrvatskaSame form

🇭🇷Izotretinoin Bonifarm 20 mg meke kapsuleCroatia · Kapsula, meka · Bonifarm d.o.o., Ulica Aleksandra Hondla 2/11, Zagreb, HrvatskaSame form

🇮🇹AisoskinItaly · Capsula molle · Fidia Farmaceutici S.P.A.Same form

🇮🇹IsdibenItaly · Capsula molle · Isdin S.R.L.Same form

🇮🇹IsodifaItaly · Capsula molle · Difa Cooper S.P.A.Same form

🇳🇱Isotretinoïne Aurobindo 10 mg, capsulesNetherlands · Capsule, zacht · Aurobindo Pharma B.V.Same form

🇳🇱Isotretinoïne Aurobindo 20 mg, capsulesNetherlands · Capsule, zacht · Aurobindo Pharma B.V.Same form

🇳🇱Isotretinoïne DOC 10 mg, zachte capsulesNetherlands · Capsule, zacht · DOC Generici S.r.l.Same form

🇳🇿OrataneNew Zealand · Cap 5 mgSame form

🇳🇿OrataneNew Zealand · Cap 10 mgSame form

🇳🇿OrataneNew Zealand · Cap 20 mgSame form

🇷🇴SOTRET 10 mgRomania · 10mg · caps. moi · Terapia S.A.Same form

🇷🇴SOTRET 20 mgRomania · 20mg · caps. moi · Terapia S.A.Same form

🇷🇸Aknova®Serbia · 10mg · kapsula, meka · Galenika Ad BeogradSame form

🇷🇸Aknova®Serbia · 20mg · kapsula, meka · Galenika Ad BeogradSame form

🇷🇸Isoskin®Serbia · 40mg · kapsula, meka · Hemofarm Ad VRŠAcSame form

🇸🇬Acnotin 10Singapore · 10MG · capsule · Goldplus Universal Pte LTDSame form

🇺🇸AbsoricaUnited States · 10MG, 20MG, 25MG … · capsule · Sun Pharm Inds INCSame form

🇺🇸Absorica LDUnited States · 16MG, 20MG, 24MG … · capsule · Sun PharmSame form

🇺🇸ClaravisUnited States · 10MG, 20MG, 30MG … · capsule · Teva Pharms USASame form

🇧🇷AcnovaBrazil · Germed Farmaceutica LtdaSame substance

🇧🇷AmalfiBrazil · Eurofarma Laboratorios S.A.Same substance

🇧🇷IsoacBrazil · Cosmed Industria de Cosmeticos e Medicamentos S.A.Same substance

🇹🇼Retin-A Cream 0.05%Taiwan · 乳膏劑 · 嬌生股份有限公司Same substance

🇹🇼Retin-A Gel 0.01%Taiwan · 外用凝膠劑 · 嬌生股份有限公司Same substance

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Saudi Food and Drug Authority

Saudi Food and Drug Authority (SFDA), foreign human medicine open-data listing, source scope 2023, retrieved 11 October 2026 UTC; exact original file and response modification date retained.

Licence: Exact SFDA open-data section explicitly offers freely usable named human medicine workbooks; factual-data scope only · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Isotretinoin
Register: Saudi Arabia (SFDA)
Status: Authorised
Status in the register: Listed by SFDA (2023 file)
Manufacturer: CATALENT GERMANY EBERBACH GmbH
Manufacturer: CATALENT GERMANY EBERBACH GmbH, Germany
Procedure: Foreign manufacture
Supply: Prescription

SFDACuracne 40MG Soft Gelatin CapsuleIsotretinoin🇸🇦Saudi ArabiaAuthorised

SFDAIsotrex Gel 0.05%Isotretinoin🇸🇦Saudi ArabiaAuthorised

SFDAORATANE 10 mg Soft CapsulesIsotretinoin🇸🇦Saudi ArabiaAuthorised

SFDAORATANE 20 mg Soft CapsulesIsotretinoin🇸🇦Saudi ArabiaAuthorised

SFDARoaccutane 20MG CapsIsotretinoin🇸🇦Saudi ArabiaAuthorised

SFDARuatine 20MG CapsuleIsotretinoin🇸🇦Saudi ArabiaAuthorised

SFDAXeractan 10 MG Soft Gelatin CapsuleIsotretinoin🇸🇦Saudi ArabiaAuthorised

SFDAXeractan 20 MG Soft Gelatin CapsuleIsotretinoin🇸🇦Saudi ArabiaAuthorised