Retour Pharmeuropa 36.2 just released

EDQM Strasbourg, France 04/04/2024
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Pharmeuropa 36.2 just released

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.2 is 30 June 2024.

Users and interested parties are welcome to comment on these drafts. It should be noted that:

  • although draft monographs must not be regarded as official standards, they will, once adopted by the Ph. Eur. Commission at a later date, become applicable and legally binding standards for the products concerned in all Ph. Eur. member states;
  • if general texts are not legally binding per se, they become mandatory when referred to in a monograph. Changes to general texts may therefore impact monographs.

It is therefore extremely important that users provide feedback on such drafts.

Comments made after adoption of the text and/or publication in the Ph. Eur. will be too late to be considered. Users may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe. This could ultimately lead to a situation where a product can no longer be marketed in Europe.

So don’t miss this opportunity to provide your comments. The 61 drafts published in Pharmeuropa 36.2 are listed here.

 

Drafts published in Pharmeuropa 36.2 (end of commenting period: 30 June 2024)

Group

1

2.5.25. Carbon monoxide in gases

Reference number: PA/PH/Exp. 9G/T (23) 12 ANP

Text number: 20525

Direct link

9G

2

2.6.41. High-throughput sequencing for the detection of viral extraneous agents

Reference number: PA/PH/Exp. 15/T (21) 27 ANP

Text number: 20641

Direct link

HTS

3

2.9.17. Test for extractable volume of parenteral preparations

Reference number: PA/PH/Exp. 12/T (20) 47 ANP

Text number: 20917

Direct link

12

4

2.9.54. Uniformity of delivered dose of inhalation and nasal preparations

Reference number: PA/PH/Exp. INH/T (18) 3 ANP

Text number: 20954

Direct link

INH

5

5.32. Cell-based preparations for human use

Reference number: PA/PH/Exp. CTP/T (21) 10 ANP

Text number: 53200

Direct link

CTP

6

5.36. mRNA vaccines for human use

Reference number: PA/PH/Exp. mRNAVAC/T (23) 9 ANP

Text number: 53600

Direct link

mRNAVAC

7

5.37. Recombinant viral vectored vaccines for human use

Reference number: PA/PH/Exp. 15/T (23) 56 ANP

Text number: 53700

Direct link

15V

8

5.39. mRNA substances for the production of mRNA vaccines for human use

Reference number: PA/PH/Exp. mRNAVAC/T (23) 8 ANP

Text number: 53900

Direct link

mRNAVAC

9

5.40. DNA template for the preparation of mRNA substances

Reference number: PA/PH/Exp. mRNAVAC/T (23) 7 ANP

Text number: 54000

Direct link

mRNAVAC

10

Amlodipine besilate

Reference number: PA/PH/Exp. 11/T (24) 3 ANP

Text number: 1491

Direct link

11

11

Aprotinin

Reference number: PA/PH/Exp. 6/T (23) 41 ANP

Text number: 0580

Direct link

6

12

Aprotinin concentrated solution

Reference number: PA/PH/Exp. 6/T (23) 39 ANP

Text number: 0579

Direct link

6

13

Bromperidol decanoate

Reference number: PA/PH/Exp. 10B/T (21) 88 ANP R1

Text number: 1397

Direct link

10B

14

Calendula for homoeopathic preparations

Reference number: PA/PH/Exp. HOM/T (08) 30 ANP

Text number: 2492

Direct link

HOM

15

Cefixime trihydrate

Reference number: PA/PH/Exp. 7/T (13) 138 ANP

Text number: 1188

Direct link

7

16

Cellulose acetate butyrate

Reference number: PA/PH/Exp. EXP/T (24) 8 ANP

Text number: 1406

Direct link

CEL

17

Chamomilla for homoeopathic preparations

Reference number: PA/PH/Exp. HOM/T (08) 29 ANP

Text number: 2493

Direct link

HOM

18

Cholesterol

Reference number: PA/PH/Exp. SIT/T (23) 37 ANP

Text number: 0993

Direct link

VIT

19

Chymotrypsin

Reference number: PA/PH/Exp. 6/T (23) 38 ANP

Text number: 0476

Direct link

6

20

Clonazepam

Reference number: PA/PH/Exp. 10B/T (24) 6 ANP

Text number: 0890

Direct link

10B

21

Clopidogrel besilate

Reference number: PA/PH/Exp. 10C/T (23) 43 ANP

Text number: 2790

Direct link

10C

22

Codergocrine mesilate

Reference number: PA/PH/Exp. 11/T (23) 97 ANP

Text number: 2060

Direct link

11

23

Danaparoid sodium

Reference number: PA/PH/Exp. 6/T (23) 40 ANP

Text number: 2090

Direct link

6

24

Daunorubicin hydrochloride

Reference number: PA/PH/Exp. 7/T (23) 66 ANP

Text number: 0662

Direct link

7

25

Ear preparations

Reference number: PA/PH/Exp. 12/T (23) 37 ANP

Text number: 0652

Direct link

12

26

Felodipine

Reference number: PA/PH/Exp. SIT/T (23) 36 ANP

Text number: 1013

Direct link

11

27

Fleeceflower root

Reference number: PA/PH/Exp. TCM/T (23) 93 ANP

Text number: 2433

Direct link

TCM

28

Foot-and-mouth disease (ruminants) vaccine (inactivated)

Reference number: PA/PH/Exp. 15V/T (23) 38 ANP

Text number: 0063

Direct link

15V

29

Fourstamen stephania root

Reference number: PA/PH/Exp. TCM/T (24) 9 ANP

Text number: 2478

Direct link

13A

30

Glycerol monostearate 40-55

Reference number: PA/PH/Exp. EXP/T (24) 4 ANP

Text number: 0495

Direct link

13H

31

Heparin calcium

Reference number: PA/PH/Exp. 6/T (23) 36 ANP

Text number: 0332

Direct link

6

32

Heparin sodium

Reference number: PA/PH/Exp. 6/T (23) 37 ANP

Text number: 0333

Direct link

6

33

Hydroxyzine hydrochloride

Reference number: PA/PH/Exp. 10B/T (23) 62 ANP

Text number: 0916

Direct link

10B

34

Kanamycin acid sulfate

Reference number: PA/PH/Exp. 7/T (23) 67 ANP

Text number: 0033

Direct link

7

35

Kanamycin monosulfate monohydrate

Reference number: PA/PH/Exp. 7/T (23) 68 ANP

Text number: 0032

Direct link

7

36

L-Malic acid

Reference number: PA/PH/Exp. 10D/T (22) 23 ANP R1

Text number: 3143

Direct link

10D

37

Linagliptin

Reference number: PA/PH/Exp. P4/T (21) 41 ANP

Text number: 3173

Direct link

P4

38

Macrogol poly(vinyl acetate)-poly(vinylcaprolactam) grafted copolymer

Reference number: PA/PH/Exp. P4/T (19) 94 ANP

Text number: 3156

Direct link

P4

39

Macrogolglycerol hydroxystearate

Reference number: PA/PH/Exp. EXP/T (24) 7 ANP

Text number: 1083

Direct link

13H

40

Macrogolglycerol ricinoleate

Reference number: PA/PH/Exp. EXP/T (24) 6 ANP

Text number: 1082

Direct link

13H

41

Metronidazole benzoate

Reference number: PA/PH/Exp. 10A/T (24) 8 ANP

Text number: 0934

Direct link

10A

42

Myrtle oil

Reference number: PA/PH/Exp. 13A/T (13) 16 ANP

Text number: 2823

Direct link

13A

43

Nasal preparations

Reference number: PA/PH/Exp. 12/T (23) 6 ANP

Text number: 0676

Direct link

12

44

Octenidine dihydrochloride

Reference number: PA/PH/Exp. 10A/T (18) 186 ANP

Text number: 3075

Direct link

10A

45

Preparations for inhalation

Reference number: PA/PH/Exp. INH/T (23) 7 ANP

Text number: 0671

Direct link

INH

46

Pressurised pharmaceutical preparations

Reference number: PA/PH/Exp. 12/T (23) 27 ANP

Text number: 0523

Direct link

12

47

Procaine hydrochloride

Reference number: PA/PH/Exp. 10A/T (23) 87 ANP

Text number: 0050

Direct link

10A

48

Rifamycin sodium

Reference number: PA/PH/Exp. 7/T (23) 69 ANP

Text number: 0432

Direct link

7

49

Sevelamer carbonate

Reference number: PA/PH/Exp. 10A/T (18) 190 ANP

Text number: 2747

Direct link

10A

50

Sevelamer hydrochloride

Reference number: PA/PH/Exp. 10A/T (18) 191 ANP

Text number: 2748

Direct link

10A

51

Streptomycin sulfate

Reference number: PA/PH/Exp. 7/T (23) 70 ANP

Text number: 0053

Direct link

7

52

Sufentanil

Reference number: PA/PH/Exp. 10B/T (22) 46 ANP

Text number: 1569

Direct link

10B

53

Sufentanil citrate

Reference number: PA/PH/Exp. 10B/T (22) 47 ANP

Text number: 1269

Direct link

10B

54

Suxamethonium chloride dihydrate

Reference number: PA/PH/Exp. 10A/T (17) 118 ANP R1

Text number: 0248

Direct link

10A

55

Tiabendazole for veterinary use

Reference number: PA/PH/Exp. 10A/T (24) 9 ANP

Text number: 0866

Direct link

10A

56

Tobramycin

Reference number: PA/PH/Exp. 7/T (23) 71 ANP

Text number: 0645

Direct link

7

57

Trypsin

Reference number: PA/PH/Exp. 6/T (23) 42 ANP

Text number: 0694

Direct link

6

58

Urokinase

Reference number: PA/PH/Exp. 6/T (23) 43 ANP

Text number: 0695

Direct link

6

59

Ursodeoxycholic acid

Reference number: PA/PH/Exp. 11/T (24) 6 ANP

Text number: 1275

Direct link

11

60

Vaccines for human use

Reference number: PA/PH/Exp. 15/T (22) 28 ANP

Text number: 0153

Direct link

15

61

Zanamivir hydrate

Reference number: PA/PH/Exp. 10C/T (23) 44 ANP

Text number: 2611

Direct link

10C