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C\_2007092EN.01002201.xml


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| 27.4.2007 | EN | Official Journal of the European Union | C 92/22 |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2007 to 31 March 2007

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC[(1)](#ntr1-C_2007092EN.01002201-E0001) or Article 38 of Directive 2001/82/EC[(2)](#ntr2-C_2007092EN.01002201-E0002))

(2007/C 92/16)

—   Suspension of a national marketing authorization

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| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| 20.3.2007 | Simvastatin | See Annex 1 | See Annex 1 | 22.3.2007 |

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[(1)](#ntc1-C_2007092EN.01002201-E0001)  [OJ L 311, 28.11.2001, p. 67](http://publications.europa.eu/resource/oj/JOL_2001_311_R_TOC).

[(2)](#ntc2-C_2007092EN.01002201-E0002)  [OJ L 311, 28.11.2001, p. 1](http://publications.europa.eu/resource/oj/JOL_2001_311_R_TOC).

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ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

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| Member State | Marketing Authorisation Holder (name and address) | Invented name | Strength | Pharmaceutical form | Route of administration |
| Denmark[(1)](#ntr1-C_2007092EN.01002301-E0001) | | | | --- | | BMM Pharma AB | | Blasieholmsgatan 2 | | S-111 48 Stockholm | | SIMVASTATIN BMM PHARMA | 10 mg | Film-coated tablets | Oral use |
| 20 mg | Film-coated tablets | Oral use |
| 40 mg | Film-coated tablets | Oral use |
| 80 mg | Film-coated tablets | Oral use |
| Finland[(2)](#ntr2-C_2007092EN.01002301-E0002) | | | | --- | | BMM Pharma AB | | Blasieholmsgatan 2 | | S-111 48 Stockholm | | SIMVASTATIN BMM PHARMA | 10 mg | Film-coated tablets | Oral use |
| 20 mg | Film-coated tablets | Oral use |
| 40 mg | Film-coated tablets | Oral use |
| 80 mg | Film-coated tablets | Oral use |
| Norway | | | | --- | | BMM Pharma AB | | Blasieholmsgatan 2 | | S-111 48 Stockholm | | SIMVASTATIN BMM PHARMA | 10 mg | Film-coated tablets | Oral use |
| 20 mg | Film-coated tablets | Oral use |
| 40 mg | Film-coated tablets | Oral use |
| 80 mg | Film-coated tablets | Oral use |
| Sweden[(3)](#ntr3-C_2007092EN.01002301-E0003) | | | | --- | | BMM Pharma AB | | Blasieholmsgatan 2 | | S-111 48 Stockholm | | SIMVASTATIN BMM PHARMA | 10 mg | Film-coated tablets | Oral use |
| 20 mg | Film-coated tablets | Oral use |
| 40 mg | Film-coated tablets | Oral use |
| 80 mg | Film-coated tablets | Oral use |
| The Netherlands | | | | --- | | NeoPharma Limited | | 57 High Street | | RG29 1LF Odiham | | Hamts | | United Kingdom | | Slimvastatine | 10 mg | Film-coated tablets | Oral use |
| 20 mg | Film-coated tablets | Oral use |
| 40 mg | Film-coated tablets | Oral use |
| 80 mg | Film-coated tablets | Oral use |

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[(1)](#ntc1-C_2007092EN.01002301-E0001)  Simvastatin ‘BMM Pharma ’has in DK been applied for but not approved

[(2)](#ntc2-C_2007092EN.01002301-E0002)  Simvastatin ‘BMM Pharma ’has in FI been applied for but not approved

[(3)](#ntc3-C_2007092EN.01002301-E0003)  Simvastatin ‘BMM Pharma ’has been recognised by SV at day 90 of MRP but national MA not yet granted

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