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Medicine name

Active substance / international non-proprietary name (INN) / common name

Medicine

Paediatric investigation plans Remove Paediatric investigation plans filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter European public assessment reports (EPAR) (2041) Apply European public assessment reports (EPAR) filter Summaries of opinion (102) Apply Summaries of opinion filter Withdrawn applications (327) Apply Withdrawn applications filter Orphan designations (2782) Apply Orphan designations filter Maximum residue limits (802) Apply Maximum residue limits filter Opinions on maximum residue limits (13) Apply Opinions on maximum residue limits filter Periodic safety update report single assessments (2612) Apply Periodic safety update report single assessments filter Shortages (50) Apply Shortages filter Opinions on medicines for use outside EU (15) Apply Opinions on medicines for use outside EU filter

PIP decision type

P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) (668) Apply P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter PM: decision on the application for modification of an agreed PIP (902) Apply PM: decision on the application for modification of an agreed PIP filter RP: decision refers to a refusal on a proposed Paediatric Investigation Plan (19) Apply RP: decision refers to a refusal on a proposed Paediatric Investigation Plan filter RPM: decision refers to a refusal on the application for modification of an agreed PIP (22) Apply RPM: decision refers to a refusal on the application for modification of an agreed PIP filter RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) (36) Apply RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter W: decision granting a waiver in all age groups for all conditions or indications (1085) Apply W: decision granting a waiver in all age groups for all conditions or indications filter

PIP condition / indication

Pharmaceutical form(s)

Route(s) of administration

Decision date

From:

To:

PIP compliance check

Yes (299) Apply Yes filter

Date of opinion

From:

To:

Compliance procedure number

Referral name

Referral status

European Commission final decision (543) Apply European Commission final decision filter CMDh final position (19) Apply CMDh final position filter Procedure started (5) Apply Procedure started filter

Referral safety status

Yes (97) Apply Yes filter

Referral type

Article 31 referrals (125) Apply Article 31 referrals filter Article 29(4) referrals (121) Apply Article 29(4) referrals filter Article 30 referrals (96) Apply Article 30 referrals filter Article 33 (45) Apply Article 33 filter Article 35 (45) Apply Article 35 filter Article 20 procedures (28) Apply Article 20 procedures filter Article 6(12) referrals (prior to January 2010) (21) Apply Article 6(12) referrals (prior to January 2010) filter Article 34 (20) Apply Article 34 filter Article 107 procedures (prior to July 2012) (15) Apply Article 107 procedures (prior to July 2012) filter Article 29 paediatrics (9) Apply Article 29 paediatrics filter Article 36 referrals (prior to July 2012) (9) Apply Article 36 referrals (prior to July 2012) filter Article 107i procedures (9) Apply Article 107i procedures filter Article 13 (6) Apply Article 13 filter Article 13 referrals (6) Apply Article 13 referrals filter Article 6(13) referrals (prior to January 2010) (5) Apply Article 6(13) referrals (prior to January 2010) filter Article 78 (5) Apply Article 78 filter Articles 39 and 40 (4) Apply Articles 39 and 40 filter Article 5(11) referrals (prior to January 2010) (2) Apply Article 5(11) referrals (prior to January 2010) filter Article 82 (2) Apply Article 82 filter

Referral reference number

Referral decision making model

PRAC-CAT-CHMP-EC (1) Apply PRAC-CAT-CHMP-EC filter PRAC-CHMP-EC (32) Apply PRAC-CHMP-EC filter PRAC-CMDh (38) Apply PRAC-CMDh filter

Referral authorisation model

Centrally and nationally authorised products (mixed) (15) Apply Centrally and nationally authorised products (mixed) filter Centrally authorised product(s) (27) Apply Centrally authorised product(s) filter Nationally authorised product(s) (78) Apply Nationally authorised product(s) filter

Referral PRAC recommendation

No further action (1) Apply No further action filter Revocation (4) Apply Revocation filter Risk minimisation measures (35) Apply Risk minimisation measures filter Suspension (9) Apply Suspension filter Variation (14) Apply Variation filter

Referral procedure start date

From:

To:

Referral PRAC recommendation date

From:

To:

ATC code

Species

Medicine type

Accelerated assessment (45) Apply Accelerated assessment filter Additional monitoring (251) Apply Additional monitoring filter Biosimilar (2) Apply Biosimilar filter Conditional approval (44) Apply Conditional approval filter Exceptional circumstances (20) Apply Exceptional circumstances filter Generic (7) Apply Generic filter Orphan medicine (109) Apply Orphan medicine filter

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