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Medicines
Spain
Isotretinoin

AEMPS 2006

Isotretinoin

ISOACNE 20 mg CAPSULAS BLANDAS

20,000 mg cápsula blandaSpainMarketedAuthorised 21 Feb 2006

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

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

IsoacneBrazil · Mantecorp Indústria Química e Farmacêutica S.A.Same brand
IsotanArgentina · 20 MG · cápsula blanda · Oxapharma S.A.Same form
Absorica LDCanada · 16 MG · Capsule · Sun Pharmaceutical Industries LimitedSame form
Absorica LDCanada · 24 MG · Capsule · Sun Pharmaceutical Industries LimitedSame form
Absorica LDCanada · 8 MG · Capsule · Sun Pharmaceutical Industries LimitedSame form
Roaccutane 10 mg meke kapsuleCroatia · kapsula, meka · CHEPLAPHARM Registration GmbH, Weiler Straβe 5 E, Lörrach, NjemačkaSame form
Izotretinoin Bonifarm 10 mg meke kapsuleCroatia · Kapsula, meka · Bonifarm d.o.o., Ulica Aleksandra Hondla 2/11, Zagreb, Hrvatska

More with the same substance on this register

Acnemin 10 MG Capsulas Blandas EfgIsotretinoin · 10 mg · cápsula blandaSpain
Acnemin 20 MG Capsulas Blandas EfgIsotretinoin · 20 mg · cápsula blandaSpain

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

🇭🇷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 10 mgSame form

🇳🇿OrataneNew Zealand · Cap 5 mgSame form

🇳🇿OrataneNew Zealand · Cap 20 mgSame form

🇷🇴ROACCUTANE 10 mgRomania · 10mg · caps. moi · Roche Romania S.R.L.Same 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 · 20mg · kapsula, meka · Galenika Ad BeogradSame form

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

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

🇸🇦Curacne 10MG Soft Gelatin CapsuleSaudi Arabia · CatalentSame form

🇸🇦Curacne 20MG Soft Gelatin CapsuleSaudi Arabia · CatalentSame form

🇸🇦Curacne 40MG Soft Gelatin CapsuleSaudi Arabia · CatalentSame form

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

🇸🇬Acnotin 20Singapore · 20 mg · capsule · Goldplus Universal Pte LTDSame form

🇸🇬NIMEGEN SOFT CAP. 10 mgSingapore · 10 mg · capsule, liquid filled · Zyfas Pharma 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

🇹🇼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

Packs

Pack	Code	Status
ISOACNE 20 mg CAPSULAS BLANDAS, 50 cápsulas	653861

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

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

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · 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
Strength: 20,000 mg
Dosage form: cápsula blanda
Route: vía oral
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 21 Feb 2006
Registration: 67571
Marketing authorisation holder: Pierre Fabre Iberica S.A.
Procedure: National, MRP or DCP
Supply: Diagnóstico Hospitalario

AEMPSDERCUTANE 10 mg CAPSULAS BLANDASIsotretinoin · 10 mg · cápsula blanda🇪🇸Spain

AEMPSDERCUTANE 20 mg CAPSULAS BLANDASIsotretinoin · 20 mg · cápsula blanda🇪🇸Spain

AEMPSDercutane 30 MG Capsulas BlandasIsotretinoin · 30 mg · cápsula blanda🇪🇸Spain

AEMPSDERCUTANE 40 mg CAPSULAS BLANDASIsotretinoin · 40 mg · cápsula blanda🇪🇸Spain

AEMPSDERCUTANE 5 mg CAPSULAS BLANDASIsotretinoin · 5 mg · cápsula blanda🇪🇸Spain

AEMPSFLEXRESAN 10 mg CAPSULAS BLANDASIsotretinoin · 10 mg · cápsula blanda🇪🇸Spain

AEMPSFLEXRESAN 20 mg CAPSULAS BLANDASIsotretinoin · 20 mg · cápsula blanda🇪🇸Spain

AEMPSISDIBEN 10 mg CAPSULAS BLANDAS EFGIsotretinoin · 10,00 mg · cápsula blanda🇪🇸Spain

AEMPSISDIBEN 20 mg CAPSULAS BLANDAS EFGIsotretinoin · 20,00 mg · cápsula blanda🇪🇸Spain

AEMPSISDIBEN 40 mg CAPSULAS BLANDASIsotretinoin · 40 mg · cápsula blanda🇪🇸Spain