EUROPEAN MEDICINES AGENCY DECISION. of 14 October 2008

Transcription

1 Eurpean Medicines Agency Dc. Ref. EMEA/522876/2008 P/84/2008 EUROPEAN MEDICINES AGENCY DECISION f 14 Octber 2008 n the applicatin fr agreement f a Paediatric Investigatin Plan fr valsartan (Divan) (EMEA PIP01-07) in accrdance with Regulatin (EC) N 1901/2006 f the Eurpean Parliament and f the Cuncil as amended (ONLY THE ENGLISH TEXT IS AUTHENTIC) 7 Westferry Circus, Canary Wharf, Lndn, E14 4HB, UK Tel. (44-20) Fax (44-20) mail@emea.eurpa.eu

2 EUROPEAN MEDICINES AGENCY DECISION f 14 Octber 2008 n the applicatin fr agreement f a Paediatric Investigatin Plan fr valsartan (Divan) (EMEA PIP01-07) in accrdance with Regulatin (EC) N 1901/2006 f the Eurpean Parliament and f the Cuncil as amended THE EUROPEAN MEDICINES AGENCY, Having regard t the Treaty establishing the Eurpean Cmmunity, Having regard t Regulatin (EC) N 1901/2006 f the Eurpean Parliament and f the Cuncil f 12 December 2006 n medicinal prducts fr paediatric use as amended and amending Regulatin (EEC) N. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulatin (EC) N 726/2004 1, Having regard t Regulatin (EC) N 726/2004 f the Eurpean Parliament and f the Cuncil f 31 March 2004 laying dwn Cmmunity prcedures fr the authrisatin and supervisin f medicinal prducts fr human and veterinary use and establishing a Eurpean Medicines Agency 2, Having regard t the applicatin submitted by Nvartis Eurpharm Limited n 1 August 2007 under Article 16(1) f Regulatin (EC) N 1901/2006 as amended als requesting a waiver under Article 13 f said Regulatin, Having regard t the pinin f the Paediatric Cmmittee f the Eurpean Medicines Agency, issued n 29 August 2008, in accrdance with Article 18 f Regulatin (EC) N 1901/2006 as amended, and Article 13 f said Regulatin, Having regard t Article 25 f Regulatin (EC) N 1901/2006 as amended, WHEREAS: (1) The Paediatric Cmmittee f the Eurpean Medicines Agency, has given a psitive pinin, (2) It is therefre apprpriate t adpt a Decisin fllwing the Paediatric Cmmittee s pinin n the Paediatric Investigatin Plan. (3) It is therefre apprpriate t adpt a Decisin granting a waiver. 1 OJ L 378, , p.1 2 OJ L 136, , p. 1 EMEA/522876/2008 Page 2/10

3 HAS ADOPTED THIS DECISION: Article 1 A Paediatric Investigatin Plan fr Valsartan (Divan), film-cated tablet, hard gelatin capsule; age apprpriate frmulatin: liquid frmulatin, ral use, the details f which are set ut in the Opinin f the Paediatric Cmmittee f the Eurpean Medicines Agency annexed heret, tgether with its appendices, is hereby agreed. Article 2 A waiver fr Valsartan (Divan), film-cated tablet, hard gelatin capsule; age apprpriate frmulatin: liquid frmulatin, ral use, the details f which are set ut in the Opinin f the Paediatric Cmmittee the Eurpean Medicines Agency annexed heret, tgether with its appendices, is hereby granted. Article 3 This decisin is addressed t Nvartis Eurpharm Limited, Wimblehurst Rad, Hrsham, West Sussex RH12 5AB, United Kingdm. Dne at Lndn, 14 Octber 2008 Fr the Eurpean Medicines Agency Thmas Lönngren Executive Directr (Signature n file) EMEA/522876/2008 Page 3/10

4 Eurpean Medicines Agency Pre-authrisatin Evaluatin f Medicines fr Human Use POSITIVE OPINION OF THE PAEDIATRIC COMMITTEE ON A REQUEST FOR AGREEMENT OF A PAEDIATRIC INVESTIGATION PLAN FOR EMEA/PDCO/445606/2008 EMEA PIP01-07 Scpe f the applicatin Active substance: Valsartan Invented name and assciated names Divan Cnditin(s): Hypertensin; Heart failure; Heart failure fllwing recent mycardial infarctin Pharmaceutical frm(s): Film-cated tablet, hard gelatin capsule Age apprpriate frmulatin: liquid frmulatin, Rute(s) f administratin: Oral use Name/crprate name f the PIP applicant: Nvartis Eurpharm Limited Infrmatin abut the authrised medicinal prduct: see Annex II Basis fr pinin Pursuant t Article 16.1f Regulatin (EC) N 1901/2006 as amended, Nvartis Eurpharm Limited submitted fr agreement t the EMEA n 26 June 2007 a paediatric investigatin plan and request fr a waiver fr the abve mentined medicinal prduct. The prcedure started n 1 August Supplementary infrmatin was prvided by the applicant n 16 June 2008 A meeting with the Paediatric Cmmittee tk place n 27 August Westferry Circus, Canary Wharf, Lndn, E14 4HB, UK Tel. (44-20) Fax (44-20) mail@emea.eurpa.eu

5 Opinin 1. The Paediatric Cmmittee, having assessed the prpsed paediatric investigatin plan in accrdance with Article 17 f Regulatin (EC) N 1901/2006 as amended, recmmends as set ut in the appended summary reprt : t agree the paediatric investigatin plan in accrdance with Article 18 f Regulatin (EC) N 1901/2006 as amended, t grant a waiver fr ne r mre subsets f the paediatric ppulatin in accrdance with Article 13 f Regulatin (EC) N 1901/2006 as amended and cncluded in accrdance with: Article 11(1)(a) f Regulatin (EC) N 1901/2006 as amended, n the grunds that the specific medicinal prduct is likely t be ineffective r unsafe in part r all f the paediatric ppulatin Article 11(1)(b) f Regulatin (EC) N 1901/2006 as amended, n the grunds that the disease r cnditin fr which the specific medicinal prduct is intended ccurs nly in adult ppulatins Article 11(1)(c) f Regulatin (EC) N 1901/2006 as amended, n the grunds that the specific medicinal prduct des nt represent a significant therapeutic benefit ver existing treatments fr paediatric patients The Icelandic and the Nrwegian Paediatric Cmmittee members agree with the abve-mentined recmmendatin f the Paediatric Cmmittee. 2. The measures and timelines f the agreed paediatric investigatin plan and the subset(s) f the paediatric ppulatin and cnditin(s) cvered by the waiver are set ut in the Annex I. This pinin is frwarded t the applicant and the Executive Directr f the Agency, tgether with its annex(es) and appendix(ces). Lndn, 29 August 2008 On behalf f the Paediatric Cmmittee Dr Daniel Brasseur, Chairman (Signature n file) EMEA/PDCO/445606/2008 Page 5/10

6 ANNEX I THE MEASURES AND TIMELINES OF THE AGREED PAEDIATRIC INVESTIGATION PLAN AND THE SUBSET(S) OF THE PAEDIATRIC POPULATION AND CONDITION(S) COVERED BY THE WAIVER EMEA/PDCO/445606/2008 Page 6/10

7 A. CONDITION(S) / DISEASE(S) Hypertensin Heart failure Heart failure after recent mycardial infarctin B. WAIVER Cnditin Hypertensin Subset(s) f the paediatric ppulatin, pharmaceutical frm(s) and rute(s) f administratin cvered The waiver applies t: - Preterm newbrn infants, term newbrn infants (0-27 d), infants and tddlers aged less than 6 mnths fr film-cated tablet, and hard gelatin capsule fr ral use Cnditin Heart failure Subset(s) f the paediatric ppulatin, pharmaceutical frm(s) and rute(s) f administratin cvered The waiver applies t - All paediatric age grups (0 t less than 18 years) fr film-cated tablet, hard gelatin capsule fr ral use Cnditin Heart failure after recent mycardial infarctin Subset(s) f the paediatric ppulatin, pharmaceutical frm(s) and rute(s) f administratin cvered The waiver applies t: - All paediatric age grups (0 t less than 18 years) fr film-cated tablet, hard gelatin capsule fr ral use EMEA/PDCO/445606/2008 Page 7/10

8 C. PAEDIATRIC INVESTIGATION PLAN C.1. Cnditin t be investigated Hypertensin Subset(s) cvered Infants and tddlers aged mre than 6 mnths, Children (2-11 y), Adlescents (12 years t less than 18 years) Frmulatin(s) Age apprpriate liquid frmulatin and strength fr ral use Prpsed PIP indicatin Treatment f Hypertensin Studies / Measures Hypertensin Area Subarea Number Descriptin Quality Frmulatin Age-apprpriate strength and industrially-prepared liquid frmulatin Clinical Efficacy Safety 1 Randmized, multicentre, duble-blind, parallel-grup active-cntrlled study t evaluate the safety and efficacy f valsartan cmpared with enalapril in 6 t less than 18 years ld Clinical Efficacy, Safety 1 Randmized, multicentre, duble-blind dse-ranging study in 6 mnths t less than 6 years ld children with hypertensin. Clinical Pharmackinetics 1 Biequivalence f extempraneus suspensin used in clinical trials versus new age-apprpriate liquid frmulatin Need fr specific measures fr lng term fllw up in relatin t ptential use in paediatric ppulatin: Yes Date f cmpletin f the paediatric investigatin plan: by September 2009 A deferral has been granted: N EMEA/PDCO/445606/2008 Page 8/10

9 ANNEX II INFORMATION ABOUT THE AUTHORISED MEDICINAL PRODUCT EMEA/PDCO/445606/2008 Page 9/10

10 EU Number N/A Invented name Strength Name Divan and 40 mg; assciated names 80 mg; 160 mg; 320 mg Pharmaceutical Frm film-cated tablet; hard gelatine capsule Rute f administratin Cntent Package Packaging (cncentratin) size ral N/A N/A N/A EMEA/PDCO/445606/ /10