1: Home (ALT-H)
2: HMA Joint (ALT-M)
3: Human Medicines (ALT-U)
- 3.1: Heads of Agencies (ALT-E)
- 3.2: CMD(h) (ALT-C)
- 3.3: MRI Product Index (ALT-R)
- 3.4: Directory (ALT-I)
4: Veterinary Medicines (ALT-V)

You are here: Human Medicines > CMD(h) > Paediatric Regulation > Article 45 and previous Worksharing

3.2.1: About CMDh (ALT-O)
3.2.2: Statistics (ALT-S)
3.2.3: Press Releases (ALT-P)
3.2.4: Procedural Guidance (ALT-L)
3.2.5: CMDh-Referrals
3.2.6: Product Information (ALT-T)
3.2.7: Advice from CMDh
3.2.8: Templates
3.2.9: CMD subgroups / working groups (ALT-G)
3.2.10: Paediatric Regulation (ALT-N)
- 3.2.10.1: Guidance Documents
- 3.2.10.2: Article 45 and previous Worksharing (ALT-4)
- 3.2.10.3: Assessment Reports
3.2.11: Questions & Answers (ALT-Q)
3.2.12: Contact Form
3.2.13: Contact Points
3.2.14: What's new history (ALT-W)

... related General Information

... related Assessment Reports

...Assessment Report Tempates

Worksharing on Article 45

List of the active substances included in the work-sharing procedure (Latest update: June 2010)
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List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation (June 2010)
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Worksharing project on paediatric data

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List of active substances and agreed SPC wordings - EU work sharing procedure in the assessment of paediatric data (Latest update: April 2010)
Excel version - Click here