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Pharmeuropa 33.4 just released

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European Pharmacopoeia
Public enquiry
News
05 October 2021
Strasbourg, France

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 33.4 is 31 December 2021.

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 41 drafts published in Pharmeuropa 33.4 are listed here.

 

 

Drafts published in Pharmeuropa 33.4 (end of commenting period: 31 December 2021)

Group

1

2.2.35. Osmolality

Reference number: PA/PH/Exp. MG/T (21) 4 ANP

Text number: 20235

Direct link

MG

2

2.9.48. Particle size and shape determination by image analysis

Reference number: PA/PH/Exp. POW/T (15) 9 ANP

Text number: 20948

Direct link

POW

3

Adhatoda vasica leaf

Reference number: PA/PH/Exp. 13A/T (18) 25 ANP

Text number: 2738

Direct link

13A

4

Ampicillin sodium

Reference number: PA/PH/Exp. 7/T (21) 59 ANP

Text number: 0578

Direct link

7

5

Betamethasone valerate

Reference number: PA/PH/Exp. SIT/T (21) 38 ANP

Text number: 0811

Direct link

10B

6

Buserelin

Reference number: PA/PH/Exp. 6/T (21) 50 ANP

Text number: 1077

Direct link

6

7

Cholesterol

Reference number: PA/PH/Exp. VIT/T (19) 40 ANP

Text number: 0993

Direct link

VIT

8

Coccidiosis vaccine (live) for chickens

Reference number: PA/PH/Exp. 15V/T (21) 28 ANP

Text number: 2326

Direct link

15V

9

Ether

Reference number: PA/PH/Exp. 10D/T (18) 53 ANP R1

Text number: 0650

Direct link

10D

10

Flumetasone pivalate

Reference number: PA/PH/Exp. 10B/T (19) 158 ANP

Text number: 1327

Direct link

10B

11

Fluorocholine (18F) injection

Reference number: PA/PH/Exp. 14/T (21) 31 ANP

Text number: 2793

Direct link

14

12

Goldenrod

Reference number: PA/PH/Exp. 13B/T (21) 15 ANP

Text number: 1892

Direct link

13B

13

Goldenrod, European

Reference number: PA/PH/Exp. 13B/T (21) 16 ANP

Text number: 1893

Direct link

13B

14

Indometacin

Reference number: PA/PH/Exp. SIT/T (21) 35 ANP

Text number: 0092

Direct link

10A

15

Ketoconazole

Reference number: PA/PH/Exp. SIT/T (21) 37 ANP

Text number: 0921

Direct link

10B

16

Lysine acetate

Reference number: PA/PH/Exp. 10D/T (21) 33 ANP

Text number: 2114

Direct link

10D

17

Methylprednisolone acetate

Reference number: PA/PH/Exp. SIT/T (21) 19 ANP

Text number: 0933

Direct link

10B

18

Mirabegron

Reference number: PA/PH/Exp. P4/T (19) 58 ANP

Text number: 3132

Direct link

P4

19

Monoclonal antibodies for human use

Reference number: PA/PH/Exp. MAB/T (21) 14 ANP

Text number: 2031

Direct link

MAB

20

Nicardipine hydrochloride

Reference number: PA/PH/Exp. SIT/T (21) 34 ANP

Text number: 2776

Direct link

10D

21

Oxygen (98 per cent)

Reference number: PA/PH/Exp. 9G/T (18) 2 ANP R3

Text number: 3098

Direct link

9G

22

Polysorbate 40

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

Text number: 1914

Direct link

13H

23

Polysorbate 20

Reference number: PA/PH/Exp. EXP/T (21) 14 ANP

Text number: 0426

Direct link

13H

24

Polysorbate 60

Reference number: PA/PH/Exp. EXP/T (21) 16 ANP

Text number: 0427

Direct link

13H

25

Polysorbate 80

Reference number: PA/PH/Exp. EXP/T (21) 17 ANP

Text number: 0428

Direct link

13H

26

Prednisolone

Reference number: PA/PH/Exp. SIT/T (21) 20 ANP

Text number: 0353

Direct link

10B

27

Prednisone

Reference number: PA/PH/Exp. 10B/T (21) 63 ANP

Text number: 0354

Direct link

10B

28

Promazine hydrochloride

Reference number: PA/PH/Exp. 10A/T (21) 9 ANP

Text number: 1365

Direct link

10A

29

Propylene glycol monocaprylate

Reference number: PA/PH/Exp. 13H/T (20) 29 ANP R1

Text number: 2799

Direct link

13H

30

Pumpkin seed

Reference number: PA/PH/Exp. 13B/T (20) 1 ANP

Text number: 2941

Direct link 

13B

31

Rutoside trihydrate

Reference number: PA/PH/Exp. 11/T (21) 36 ANP

Text number: 1795

Direct link

10A

32

Saxagliptin monohydrate

Reference number: PA/PH/Exp. P4/T (19) 48 ANP

Text number: 3136

Direct link

P4

33

Sildenafil citrate

Reference number: PA/PH/Exp. SIT/T (21) 36 ANP

Text number: 2270

Direct link

10B

34

Somatropin

Reference number: PA/PH/Exp. 6/T (21) 13 ANP

Text number: 0951

Direct link

6

35

Somatropin concentrated solution

Reference number: PA/PH/Exp. 6/T (21) 12 ANP

Text number: 0950

Direct link

6

36

Somatropin injection

Reference number: PA/PH/Exp. 6/T (21) 15 ANP

Text number: 2370

Direct link

6

37

Somatropin powder for injection

Reference number: PA/PH/Exp. 6/T (21) 14 ANP

Text number: 0952

Direct link

6

38

Tazobactam

Reference number: PA/PH/Exp. 7/T (19) 34 ANP

Text number: 2210

Direct link

7

39

Technetium (99mTc) sestamibi injection

Reference number: PA/PH/Exp. 14/T (21) 21 ANP

Text number: 1926

Direct link

14

40

Thiopental sodium and sodium carbonate

Reference number: PA/PH/Exp. 10A/T (13) 22 ANP

Text number: 0212

Direct link

10A

41

Winter ulcer vaccine (inactivated, oil-adjuvanted, injectable) for salmonids

Reference number: PA/PH/Exp. 15V/T (18) 45 ANP R1

Text number: 2151

Direct link

15V

 

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