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Medicines
Croatia
Isotretinoin

HALMED 2024

Isotretinoin

Roaccutane 10 mg meke kapsule

kapsula, mekaCroatiaMarketedAuthorised 6 Aug 2024

Ask Osler about it

On this page

In other countries
Packs
Sources and licences

In other countries

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

ROACCUTANE 10 mgRomania · 10mg · caps. moi · Roche Romania S.R.L.Same brand
Roaccutane 10MG CapsSaudi Arabia · CATALENT GERMANY EBERBACH GmbHSame brand
Roaccutane 20MG CapsSaudi Arabia · CATALENT GERMANY EBERBACH GmbHSame 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 · 24 MG · Capsule · Sun Pharmaceutical Industries LimitedSame form

More with the same substance on this register

Izotretinoin Bonifarm 10 mg meke kapsuleIsotretinoin · Kapsula, mekaCroatia
Izotretinoin Bonifarm 20 mg meke kapsuleIsotretinoin · Kapsula, mekaCroatia

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.

🇨🇦Absorica LDCanada · 16 MG · Capsule · Sun Pharmaceutical Industries LimitedSame form

🇨🇦Absorica LDCanada · 8 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

🇮🇹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

🇷🇴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 · 10mg · kapsula, meka · Hemofarm Ad VRŠAcSame form

🇸🇦Curacne 10MG Soft Gelatin CapsuleSaudi Arabia · CatalentSame 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

Packs

Pack	Code	Status
30 kapsula u blisteru, u kutiji	HR-H-462694255-01	stavljeno u promet

Sources and licences

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

HALMED — Agencija za lijekove i medicinske proizvode RH

HALMED, Baza lijekova, source export 08.10.2026., acquired 2026-10-08; factual structured adaptation; Otvorena dozvola RH, NN 67/2017.

Licence: Otvorena dozvola RH NN 67/2017 · Added 8 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
Dosage form: kapsula, meka
Register: Croatia (HALMED)
Status: Marketed
Status in the register: stavljeno u promet; nema nestašice
Authorised: 6 Aug 2024
Registration: HR-H-462694255
Marketing authorisation holder: CHEPLAPHARM Registration GmbH, Weiler Straβe 5 E, Lörrach, Njemačka
Manufacturer: Roche Pharma AG, Grenzach-Wyhlen, Njemačka Catalent Germany Eberbach GmbH, Eberbach/Baden, Njemačka
ATC code: D10BA01
Group: Dermatologicals
Procedure: National, MRP or DCP
Supply: na recept; u ljekarni