Updated PRAC PRAC Comments from Rapporteur AR Rapporteur AR PRAC/MAH (**) (***)
PRAC Recommendation
CAT/CHMP members comments (**)
CAT Opinion
CHMP Opinion
A43
30/07/2020
28/09/2020
28/10/2020
12/11/2020
26/11/2020
01/12/2020
04/12/2020
10/12/2020
A44
17/09/2020
16/11/2020
16/12/2020
31/12/2020
14/01/2021
19/01/2021
22/01/2021
28/01/2021
A45
15/10/2020
14/12/2020
13/01/2021
28/01/2021
11/02/2021
16/02/2021
19/02/2021
25/02/2021
A46
12/11/2020
11/01/2021
10/02/2021
25/02/2021
11/03/2021
16/03/2021
19/03/2021
25/03/2021
A47
11/12/2020
09/02/2021
11/03/2021
26/03/2021
09/04/2021
13/04/2021
16/04/2021
22/04/2021
A48
07/01/2021
08/03/2021
07/04/2021
22/04/2021
06/05/2021
07/05/2021
12/05/2021
20/05/2021
A49
11/02/2021
12/04/2021
12/05/2021
27/05/2021
10/06/2021
15/06/2021
18/06/2021
24/06/2021
A50
11/03/2021
10/05/2021
09/06/2021
24/06/2021
08/07/2021
13/07/2021
16/07/2021
22/07/2021
A52
07/05/2021
06/07/2021
05/08/2021
20/08/2021
03/09/2021
07/09/2021
10/09/2021
16/09/2021
A53
03/06/2021
02/08/2021
01/09/2021
16/09/2021
30/09/2021
05/10/2021
08/10/2021
14/10/2021
A54
01/07/2021
31/08/2021
29/09/2021
14/10/2021
28/10/2021
02/11/2021
05/11/2021
11/11/2021
A55
05/08/2021
04/10/2021
03/11/2021
18/11/2021
02/12/2021
07/12/2021
10/12/2021
16/12/2021
A51
(*) As there is no submission cut-off date, any ATMP PSUR submitted until the day before procedure start will be started on the procedure start date. (**) Comments from PRAC, CAT or CHMP members are not made available to Marketing Authorisation Holders (MAHs). (***) An updated AR is optional and dependent on the comments received from the MAH and PRAC members which create the need for the update.
Sep 13, 2017 - Authorisation number. National Authorisation Number. MAH of product in the member state. Member State where product is authorised. ENTEROGERMINA 6 miliardi/2 g polvere per sospensione orale not available. 013046103. SANOFI SPA. IT. NOR
Nov 30, 2017 - Page 2/8. Product Name. (in authorisation country). MRP/DCP Authorisation. Number. National Authorisation. Number. MAH of product in the Member. State. Member State where product is authorised. Sporanox 10 ... Trisporal O.S.-drank 10 m
Oct 26, 2017 - MRP/DCP Authorisation number. National Authorisation Number. MAH of product in the member state. Member State where product is authorised obložene tablete. OPERATIONS LUXEMBOURG S.A.. FROTAN 2,5 mg filmsko obložene tablete. FR/H/0199
Apr 12, 2018 - Human Medicines Evaluation Division. List of nationally authorised medicinal products ... List of nationally authorised medicinal products. EMA/234056/2018. Page 3/4. Product Name (in authorisation country). MRP/DCP Authorisation numbe
European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 11 October 2017. EMA/764352/2017. Human Medicines Evaluation Division. List of nationally authorised medicinal products. Active substance(s): amlodipine.
