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1 Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of and marketing authorisation holders in the Member s 1

2 Austria Austria Austria Austria Belgium Belgium Belgium AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien, Austria AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien, Austria AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien, Austria AstraZeneca Österreich GmbH, Schwarzenbergplatz 7, A-1037 Wien, Austria NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium Crestor 5 mg Filmtabletten 5 mg Film coated tablets Oral use Crestor 10 mg 10 mg Film coated tablets Oral use Filmtabletten Crestor 20 mg 20 mg Film coated tablets Oral use Filmtabletten Crestor 40 mg 40 mg Film coated tablets Oral use Filmtabletten 2

3 Belgium Bulgaria Bulgaria Bulgaria Croatia Croatia NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium AstraZeneca Pharmaceuticals AB, S Södertälje, Sweden AstraZeneca Pharmaceuticals AB, S Södertälje, Sweden AstraZeneca Pharmaceuticals AB, S Södertälje, Sweden AstraZeneca d.o.o. Radnička cesta Zagreb Croatia AstraZeneca d.o.o. Radnička cesta Zagreb Croatia Crestor 40 mg Film coated tablets Oral use Crestor 5 mg 5 mg Film coated tablets Oral use filmom obložene tablete Crestor 10 mg 10 mg Film coated tablets Oral use filmom obložene tablete 3

4 Croatia Croatia Cyprus Cyprus Cyprus Cyprus AstraZeneca d.o.o. Radnička cesta Zagreb Croatia AstraZeneca d.o.o. Radnička cesta Zagreb Croatia,, London W2 6BD,,, London W2 6BD,,, London W2 6BD,,, London W2 6BD, Crestor 20 mg filmom obložene tablete 20 mg Film coated tablets Oral use Crestor 40 mg 40 mg Film coated tablets Oral use filmom obložene tablete Crestor 40 mg Film coated tablets Oral use 4

5 Czech Republic Czech Republic Czech Republic Czech Republic Denmark Denmark, London W2 6BD, London W2 6BD, London W2 6BD, London W2 6BD AstraZeneca A/S Arne Jacobsens Allé København S Denmark AstraZeneca A/S Arne Jacobsens Allé København S Denmark Crestor 5 mg 5 mg Film coated tablets Oral use Crestor 10 mg 10 mg Film coated tablets Oral use Crestor 20 mg 20 mg Film coated tablets Oral use Crestor 40 mg 40 mg Film coated tablets Oral use 5

6 Denmark Denmark Estonia Estonia Estonia Finland AstraZeneca A/S Arne Jacobsens Allé København S Denmark AstraZeneca A/S Arne Jacobsens Allé København S Denmark AstraZeneca UK Ltd., London W2 6BD, AstraZeneca UK Ltd., London W2 6BD, AstraZeneca UK Ltd., London W2 6BD, AstraZeneca Oy Itsehallintokuja Espoo Finland Crestor 40 mg Film coated tablets Oral use 6

7 Finland Finland Finland France France France Germany AstraZeneca Oy Itsehallintokuja Espoo Finland AstraZeneca Oy Itsehallintokuja Espoo Finland AstraZeneca Oy Itsehallintokuja Espoo Finland AstraZeneca 1, Place Renault Rueil-Malmaison Cedex, France AstraZeneca 1, Place Renault Rueil-Malmaison Cedex, France AstraZeneca 1, Place Renault Rueil-Malmaison Cedex, France AstraZeneca GmbH, Wedel, Germany Crestor 40 mg Film coated tablets Oral use CRESTOR 5 mg 5 mg Film coated tablets Oral use Filmtabletten 7

8 Germany Germany Germany Greece Greece Greece Greece AstraZeneca GmbH, Wedel, Germany AstraZeneca GmbH, Wedel, Germany AstraZeneca GmbH, Wedel, Germany AstraZeneca SA 4 Theotokopoulou & Astronafton str Maroussi, Athens Greece AstraZeneca SA 4 Theotokopoulou & Astronafton str Maroussi, Athens Greece AstraZeneca SA 4 Theotokopoulou & Astronafton str Maroussi, Athens Greece AstraZeneca SA 4 Theotokopoulou & Astronafton str Maroussi, Athens Greece CRESTOR 10 mg Film coated tablets Oral use Filmtabletten 10 mg CRESTOR 20 mg 20 mg Film coated tablets Oral use Filmtabletten CRESTOR 40 mg 40 mg Film coated tablets Oral use Filmtabletten Crestor 40 mg Film coated tablets Oral use 8

9 Hungary Hungary Hungary Iceland Iceland Iceland AstraZeneca Kft., 1113 Budapest, Bocskai út , Hungary AstraZeneca Kft., 1113 Budapest, Bocskai út , Hungary AstraZeneca Kft., 1113 Budapest, Bocskai út , Hungary AstraZeneca A/S Arne Jacobsens Allé København S Denmark AstraZeneca A/S Arne Jacobsens Allé København S Denmark AstraZeneca A/S Arne Jacobsens Allé København S Denmark Crestor 5 mg filmtabletta 5 mg Film coated tablets Oral use Crestor 10 mg 10 mg Film coated tablets Oral use filmtabletta Crestor 20 mg 20 mg Film coated tablets Oral use filmtabletta 9

10 Iceland Ireland Ireland Ireland Ireland AstraZeneca A/S Arne Jacobsens Allé København S Denmark, 600 Capability Green, Luton, LU1 3LU,, 600 Capability Green, Luton, LU1 3LU,, 600 Capability Green, Luton, LU1 3LU,, 600 Capability Green, Luton, LU1 3LU, AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), Crestor 40 mg Film coated tablets Oral use Crestor Film coated tablets Oral use 10 mg Crestor 40 mg Film coated tablets Oral use 10

11 AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), Crestor 40 mg Film coated tablets Oral use Cirantan 5 mg Film coated tablets Oral use Cirantan 10 mg Film coated tablets Oral use Cirantan 20 mg Film coated tablets Oral use 11

12 AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza Basiglio (MI), Simesa S.P.A. Palazzo Galileo, Via F. Sforza, Basiglio (MI), Cirantan 40 mg Film coated tablets Oral use Provisacor 5 mg Film coated tablets Oral use Provisacor 10 mg Film coated tablets Oral use Provisacor 20 mg Film coated tablets Oral use Provisacor 40 mg Film coated tablets Oral use Simestat 5 mg Film coated tablets Oral use 12

13 Latvia Latvia Latvia Simesa S.P.A. Palazzo Galileo, Via F. Sforza, Basiglio (MI), Simesa S.P.A. Palazzo Galileo, Via F. Sforza, Basiglio (MI), Simesa S.P.A. Palazzo Galileo, Via F. Sforza, Basiglio (MI), London W2 6BD London W2 6BD London W2 6BD Simestat 10 mg Film coated tablets Oral use Simestat 20 mg Film coated tablets Oral use Simestat 40 mg Film coated tablets Oral use Crestor 5 mg 5 mg Film coated tablets Oral use apvalkotās tabletes Crestor 10 mg 10 mg Film coated tablets Oral use apvalkotās tabletes Crestor 20 mg 20 mg Film coated tablets Oral use apvalkotās tabletes 13

14 Latvia Lithuania Lithuania Lithuania Lithuania Luxembourg London W2 6BD London W2 6BD London W2 6BD London W2 6BD London W2 6BD NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium Crestor 40 mg apvalkotās tabletes 40 mg Film coated tablets Oral use Crestor 40 mg Film coated tablets Oral use 14

15 Luxembourg Luxembourg Luxembourg Malta Malta Malta NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium London W2 6BD London W2 6BD London W2 6BD Crestor 40 mg Film coated tablets Oral use 15

16 Malta The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands London W2 6BD AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands Crestor 40 mg Film coated tablets Oral use Crestor 40 mg Film coated tablets Oral use Cirantan 5 mg Film coated tablets Oral use 16

17 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands Cirantan 10 mg Film coated tablets Oral use Cirantan 20 mg Film coated tablets Oral use Cirantan 40 mg Film coated tablets Oral use Provisacor 5 mg Film coated tablets Oral use Provisacor 10 mg Film coated tablets Oral use Provisacor 20 mg Film coated tablets Oral use 17

18 The Netherlands The Netherlands The Netherlands The Netherlands The Netherlands Norway AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca BV Louis Pasteurlaan EE Zoetermeer The Netherlands AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway Provisacor 40 mg Film coated tablets Oral use Rosuvastatin 5 mg Film coated tablets Oral use AstraZeneca Rosuvastatin 10 mg Film coated tablets Oral use AstraZeneca Rosuvastatin 20 mg Film coated tablets Oral use AstraZeneca Rosuvastatin 40 mg Film coated tablets Oral use AstraZeneca 18

19 Norway Norway Norway Poland Poland Poland Poland AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway AstraZeneca AS Postboks 6050, Etterstad 0601 Oslo Norway AstraZeneca AB, S Södertälje, Sweden AstraZeneca AB, S Södertälje, Sweden AstraZeneca AB, S Södertälje, Sweden AstraZeneca AB, S Södertälje, Sweden Crestor 40 mg Film coated tablets Oral use Crestor 40 mg Film coated tablets Oral use 19

20 Portugal Portugal Portugal Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7 Queluz de Baixo Barcarena Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7 Queluz de Baixo Barcarena Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7 Queluz de Baixo Barcarena Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7 Queluz de Baixo Barcarena Portugal Crestor 5 mg 5 mg Film coated tablets Oral use Crestor 10 mg 10 mg Film coated tablets Oral use Crestor 20 mg 20 mg Film coated tablets Oral use Crestor 40 mg 40 mg Film coated tablets Oral use 20

21 Portugal Portugal Portugal Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7, Queluz de Baixo Barcarena Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7, Queluz de Baixo Barcarena Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7, Queluz de Baixo Barcarena Portugal AstraZeneca Produtos Farmacêuticos, Lda. Rua Humberto Madeira, 7, Queluz de Baixo Barcarena Portugal Visacor 5 mg 5 mg Film coated tablets Oral use Visacor 10 mg 10 mg Film coated tablets Oral use Visacor 20 mg 20 mg Film coated tablets Oral use Visacor 40 mg 40 mg Film coated tablets Oral use 21

22 Romania Romania Romania Romania Slovak Republic Slovak Republic, London W2 6BD,, London W2 6BD,, London W2 6BD,, London W2 6BD, AstraZeneca UK Ltd London, W2 6BD, AstraZeneca UK Ltd London, W2 6BD, Crestor 5 mg comprimate filmate 5 mg Film coated tablets Oral use Crestor 10 mg 10 mg Film coated tablets Oral use comprimate filmate Crestor 20 mg 20 mg Film coated tablets Oral use comprimate filmate Crestor 40 mg 40 mg Film coated tablets Oral use comprimate filmate CRESTOR 5 mg 5 mg Film coated tablets Oral use CRESTOR 10 mg 10 mg Film coated tablets Oral use 22

23 Slovak Republic Slovak Republic Slovenia Slovenia Slovenia Slovenia AstraZeneca UK Ltd London, W2 6BD, AstraZeneca UK Ltd London, W2 6BD, London, W2 6BD, London, W2 6BD, London, W2 6BD, London, W2 6BD, CRESTOR 20 mg 20 mg Film coated tablets Oral use CRESTOR 40 mg 40mg Film coated tablets Oral use Crestor 5 mg 5 mg Film coated tablets Oral use filmsko obložene tablete Crestor 10 mg 10 mg Film coated tablets Oral use filmsko obložene tablete Crestor 20 mg 20 mg Film coated tablets Oral use filmsko obložene tablete Crestor 40 mg 40 mg Film coated tablets Oral use filmsko obložene tablete 23

24 Spain Spain Spain Spain Spain AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble. C/ Serrano Galvache 56, Madrid, Spain. AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble. C/ Serrano Galvache 56, Madrid, Spain. AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble. C/ Serrano Galvache 56, Madrid, Spain. AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble. C/ Serrano Galvache 56, Madrid, Spain. AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble. C/ Serrano Galvache 56, Madrid, Spain. Crestor 5 mg comprimidos recubiertos con película Crestor 10 mg comprimidos recubiertos con película Crestor 20 mg comprimidos recubiertos con película Crestor 40 mg comprimidos recubiertos con película Provisacor 5 mg comprimidos recubiertos con película 5 mg Film coated tablets Oral use 10 mg Film coated tablets Oral use 20 mg Film coated tablets Oral use 40 mg Film coated tablets Oral use 5 mg Film coated tablets Oral use 24

25 Spain Spain Spain Sweden Sweden Sweden Sweden AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble. C/ Serrano Galvache 56, Madrid, Spain. AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble. C/ Serrano Galvache 56, Madrid, Spain. AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble. C/ Serrano Galvache 56, Madrid, Spain. AstraZeneca AB, S Södertälje Sweden AstraZeneca AB, S Södertälje Sweden AstraZeneca AB, S Södertälje Sweden AstraZeneca AB, S Södertälje Sweden Provisacor 10 mg comprimidos recubiertos con película 10 mg Film coated tablets Oral use Provisacor 20 mg 20 mg Film coated tablets Oral use comprimidos recubiertos con película Provisacor 40 mg 40 mg Film coated tablets Oral use comprimidos recubiertos con película Crestor 40 mg Film coated tablets Oral use 25

26 United Kingdom United Kingdom United Kingdom United Kingdom, 600 Capability Green, Luton, LU1 3LU,, 600 Capability Green, Luton, LU1 3LU,, 600 Capability Green, Luton, LU1 3LU,, 600 Capability Green, Luton, LU1 3LU, Crestor 40 mg Film coated tablets Oral use 26

27 Annex II Amendments to the Summary of Product Characteristics and Package Leaflet This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure and valid at the time of the Commission Decision. The product information may be subsequently updated by the Member competent authorities, in liaison with the Reference Member, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC. 27

28 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR CRESTOR AND ASSOCIATED NAMES 4. CLINICAL PARTICULARS 4.1 Therapeutic indications [The wording of the indication for treatment of hypercholesterolaemia should be replaced with the following:] Treatment of hypercholesterolaemia Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. 4.2 Posology and method of [Existing information on the paediatric population should be replaced with the following:] Paediatric population Paediatric use should only be carried out by specialists. Children and adolescents 6 to 17 years of age (Tanner Stage <II-V) In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily. In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population. In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily. Safety and efficacy of doses greater than 20 mg have not been studied in this population. Titration should be conducted according to the individual response and tolerability in paediatric patients, as recommended by the paediatric treatment recommendations (see Section 4.4). Children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment initiation; this diet should be continued during rosuvastatin treatment. Experience in children with homozygous familial hypercholesterolaemia is limited to a small number of children aged between 8 and 17 years. The 40 mg tablet is not suitable for use in paediatric patients. Children younger than 6 years The safety and efficacy of use in children younger than 6 years has not been studied. Therefore, Crestor is not recommended for use in children younger than 6 years. 4.4 Special warnings and precautions for use [Existing information on the paediatric population should be replaced with the following:] Paediatric population The evaluation of linear growth (height), weight, BMI (body mass index), and secondary characteristics of sexual maturation by Tanner staging in paediatric patients 6 to 17 years of age taking rosuvastatin 28

29 is limited to a two-year period. After two years of study treatment, no effect on growth, weight, BMI or sexual maturation was detected (see Section 5.1). In a clinical trial of children and adolescents receiving rosuvastatin for 52 weeks, CK elevations >10xULN and muscle symptoms following exercise or increased physical activity were observed more frequently compared to observations in clinical trials in adults (see Section 4.8). 5.1 Pharmacodynamic properties [Existing information on the paediatric population should be replaced with the following:] Paediatric population In a double-blind, randomized, multi-centre, placebo-controlled, 12-week study (n=176, 97 male and 79 female) followed by a 40-week (n=173, 96 male and 77 female), open-label, rosuvastatin dosetitration phase, patients years of age (Tanner stage II-V, females at least 1 year postmenarche) with heterozygous familial hypercholesterolaemia received rosuvastatin 5, 10 or 20 mg or placebo daily for 12 weeks and then all received rosuvastatin daily for 40 weeks. At study entry, approximately 30% of the patients were years and approximately 17%, 18%, 40%, and 25% were Tanner stage II, III, IV, and V, respectively. LDL-C was reduced 38.3%, 44.6%, and 50.0% by rosuvastatin 5, 10 and 20 mg, respectively, compared to 0.7% for placebo. At the end of the 40-week, open-label, titration to goal, dosing up to a maximum of 20 mg once daily, 70 of 173 patients (40.5%) had achieved the LDL-C goal of less than 2.8 mmol/l. After 52 weeks of study treatment, no effect on growth, weight, BMI or sexual maturation was detected (see Section 4.4). This trial (n=176) was not suited for comparison of rare adverse drug events. Rosuvastatin was also studied in a 2-year open-label, titration-to-goal study in 198 children with heterozygous familial hypercholesterolaemia aged 6 to 17 years (88 male and 110 female, Tanner stage <II-V). The starting dose for all patients was 5 mg rosuvastatin once daily. Patients aged 6 to 9 years (n=64) could titrate to a maximum dose of 10 mg once daily and patients aged 10 to 17 years (n=134) to a maximum dose of 20 mg once daily. After 24 months of treatment with rosuvastatin, the LS mean percent reduction from the baseline value in LDL-C was -43% (Baseline: 236 mg/dl, Month 24: 133 mg/dl). For each age group, the LS mean percent reductions from baseline values in LDL-C were -43% (Baseline: 234 mg/dl, Month 24: 124 mg/dl), -45% (Baseline: 234 mg/dl, 124 mg/dl ), and -35% (Baseline: 241 mg/dl, Month 24: 153 mg/dl) in the 6 to <10, 10 to <14, and 14 to <18 age groups, respectively. Rosuvastatin 5 mg, 10 mg, and 20 mg also achieved statistically significant mean changes from baseline for the following secondary lipid and lipoprotein variables: HDL-C, TC, non-hdl-c,ldl-c/hdl- C, TC/HDL-C, TG/HDL-C, non HDL C/HDL-C, ApoB, ApoB/ApoA-1. These changes were each in the direction of improved lipid responses and were sustained over 2 years. No effect on growth, weight, BMI or sexual maturation was detected after 24 months of treatment (see Section 4.4). The European Medicines Agency has waived the obligation to submit the results of studies with rosuvastatin in all subsets of the paediatric population in the treatment of homozygous familial hypercholesterolaemia, primary combined (mixed) dyslipidaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use). 5.2 Pharmacokinetic properties [Existing information on the paediatric population should be replaced with the following:] Paediatric population: Two pharmacokinetic studies with rosuvastatin (given as tablets) in paediatric patients with heterozygous familial hypercholesterolaemia or 6-17 years of age (total of

30 patients) demonstrated that exposure in paediatric patients appears comparable to or lower than that in adult patients. Rosuvastatin exposure was predictable with respect to dose and time over a 2-year period. 30

31 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR CRESTOR AND ASSOCIATED NAMES 1. What CRESTOR is and what it is used for [Existing wording of this section should be replaced with the following:] CRESTOR belongs to a group of medicines called statins. You have been prescribed CRESTOR because: You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Crestor is used in adults, adolescents and children 6 years or older to treat high cholesterol. You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol-lowering diet and exercise while you are taking CRESTOR. Or You have other factors that increase your risk of having a heart attack, stroke or related health problems. 2. What you need to know before you take CRESTOR [Existing information on the paediatric population should be replaced with the following:] Children and adolescents If the patient is under 6 years old: CRESTOR should not be given to children younger than 6 years. If the patient is below 18 years of age: The CRESTOR 40 mg tablet is not suitable for use in children and adolescents below 18 years of age. 3. How to take CRESTOR [Existing information on the paediatric population should be replaced with the following:] Use in children and adolescents aged 6 17 years The usual start dose is 5 mg. Your doctor may increase your dose to find the right amount of CRESTOR for you. The maximum daily dose of CRESTOR is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years. Take your dose once a day. CRESTOR 40 mg tablet should not be used by children. 31

32 Annex III Conditions of the marketing authorisations 32

33 National Competent Authorities (NCAs), coordinated by the Reference Member where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders (MAHs): An updated version of the Risk Management Plan will be submitted to National Competent Authorities within 3 months of the Commission Decision for this procedure, to reflect the updated information on the paediatric population as agreed by CHMP. 33

Plendil retard 2,5 mg - Filmtabletten

Plendil retard 2,5 mg - Filmtabletten Annex I List of the names, pharmaceutical form, strength of the medicinal product, route of administration, Marketing Authorisation Holders in the Member States 1 Member State EU/EEA Marketing authorisation