List Item Isotretinoin
ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER, PACKAGING AND PACKAGE SIZES IN THE MEMBER STATES
EMEA/CPMP/2811/03 1/22 EMEA 2003
Applicant / Invented name Pharmaceutical Route of Package-sizes Marketing Form administration Member State Strength Packaging Authorisation Holder Austria Schering Lurantal 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, Lurantal 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
Belgium Schering Lurantal 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, Lurantal 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
Denmark Schering Scheritonin 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, Scheritonin 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
Finland Schering Lurantal 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180
EMEA/CPMP/2811/03 2/22 EMEA 2003
Burgess Hill, Lurantal 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
France Schering Scheritonin 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, Scheritonin 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
Germany Schering Lurantal 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, Lurantal 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
Greece Schering Scheritonin 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, Scheritonin 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
Ireland Schering Scheritonin 5 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180
EMEA/CPMP/2811/03 3/22 EMEA 2003
Burgess Hill, Scheritonin 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom Scheritonin 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 & 180 Italy Schering Rexidal 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, West Sussex, RH15 9NE, United Kingdom
Luxembourg Schering Lurantal 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, Lurantal 20mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
The Netherlands Schering Lurantal 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, Lurantal 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
Portugal Schering Scheritonin 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180
EMEA/CPMP/2811/03 4/22 EMEA 2003
Burgess Hill, Scheritonin 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
Spain Schering Trivane 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Healthcare Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, Trivane 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, West Sussex, 84, 90, 100, 112, 120, RH15 9NE, 168 & 180 United Kingdom
UK Schering Health Isotretinoin 5 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, Care Ltd 84, 90, 100, 112, 120, The Brow, 168 & 180 Burgess Hill, West Sussex, sotretinoin 10 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, RH15 9NE, 84, 90, 100, 112, 120, United Kingdom 168 & 180
Isotretinoin 20 mg Soft capsules Oral use Blister 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 & 180
EMEA/CPMP/2811/03 5/22 EMEA 2003
ANNEX II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
EMEA/CPMP/2811/03 6/22 EMEA 2003
SCIENTIFIC CONCLUSIONS
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Isotretinoin / Lurantal / Trivane / Rexidal / Scheritonin (see Annex I) Isotretinoin (13-cis-retinoic acid) is a retinoid compound and a derivative of vitamin A. Isotretinoin is used for the systemic treatment of acne. Like all retinoids, isotretinoin is teratogen and is contraindicated during pregnancy to avoid congenital defects.
Isotretinoin / Lurantal / Rexidal / Scheritonin / Trivane has been granted a marketing authorisation in UK, as essentially similar (generic) to the originator Roaccutane from Roche. Before the end of a mutual recognition procedure in all EU Members States (except Sweden), France presented to the EMEA a referral considering that the pregnancy prevention programme as proposed in the MRP summary of product characteristics was not acceptable and requested amendments to various sections of the SPCs. In addition, France considered that a PSUR reporting of 5 years for isotretinoin was not acceptable.
Based on the ground for referrals and the CPMP questions, the applicant proposed a Pregnancy Prevention Programme and an updated summary of product characteristics.